Case Studies

Emergency Cases Treated with Investigational PhageBank™

When seeking expanded access to any investigational medical product, it is critical that the patient and his/her treating physician consider all possible risks. Investigational medical products, by definition, have not yet been evaluated for safety or effectiveness by the FDA and have not yet been approved. An investigational medical product may cause unexpected side effects, some of which could be serious. Additional information regarding expanded access can be found at the FDA.

The following expanded access case studies are provided in the spirit of dissemination and exchange of scientific information concerning APT’s investigational PhageBank™ therapy. The administration of PhageBank for these cases was not within a carefully controlled clinical trial and therefore the results cannot be construed as validation of PhageBank’s safety and efficacy.

10Pathogens (2 infections were polymicrobial)

Bacterial SpeciesCases
Achromobacter xylosoxidans1
Acinetobacter baumannii5
Burkholderia cenocepacia1
Burkholderia dolosa1
Burkholderia gladioli1
Escherichia coli2
Klebsiella pneumoniae4
Pseudomonas aeruginosa8
Staphylococcus aureus4
Staphylococcus epidermidis1

11Infection Types

Infection TypeCases
Bacteremia2
Central Nervous System Infection1
Graft Infection1
Intra-abdominal infection1
Lung infection5
LVAD Infection3
Mastoiditis1
Osteomyletis3
Prosthetic joint infection7
Urinary Tract Infection2
Wound infection3

Intra-abdominal infection

San Diego, CA

Patient1
Age68
GenderMale
Year2017
Phage RouteIV & Percutaneous
PathogenAcinetobacter baumannii

Patient #1, a 68 year old male, developed a multidrug resistant Acinetobacter baumannii infected pancreatic pseudocyst. Despite multiple antibiotic courses, the patient deteriorated over a four month period and became comatose. Bacteriophage therapy was administered. A marked improvement in the patient’s condition was observed within 48 hours of starting intravenous therapy. Following 11 weeks of therapy, the patient made a full recovery. This case was published in the journal Antimicrobial Agents and Chemotherapy as “Development and Use of Personalized Bacteriophage-Based Therapeutic Cocktails to Treat a Patient with a Disseminated Resistant Acinetobacter baumannii Infection” (Schooley 2017).

Bacteremia

Washington, DC

Patient2
Age2
GenderMale
Year2017
Phage RouteIV
PathogenPseudomonas aeruginosa

Patient #2, a 2 year old male with a history of DiGeorge Syndrome and complex congenital heart disease. Following cardiac surgery, he developed a recalcitrant multidrug resistant Pseudomonas aeruginosa bacteremia. Bacteriophage therapy was initiated intravenously, but then held due to progressive heart failure. Despite premature cessation of therapy, blood cultures obtained 4 and 5 days subsequently were sterile. Therapy was resumed 11 days after cessation, and blood cultures that had become positive reverted back to sterile. Unfortunately, the patient decompensated, presumably due to progression of undrained fluid collections, antecedent influenza infection, and end-stage cardiac failure. This case was published in the Journal of Pediatric Infectious Diseases Society as “Refractory Pseudomonas Bacteremia in a 2-Year-Old Sterilized by Bacteriophage Therapy” (Duplessis 2017).

Wound infection

San Diego, CA

Patient3
Age77
GenderMale
Year2017
Phage RouteIV
PathogenAcinetobacter baumannii

Patient #3, a 77 year old male, suffered a traumatic brain injury. He developed a craniectomy site infection with multidrug resistant Acinetobacter baumannii. Intravenous  bacteriophage therapy was administered for 8 days. The patient initially seemed more alert, but fever and leukocytosis persisted. The craniectomy site and skin flap healed well. Before receipt of the second phage cocktail, the patient’s family decided to withdraw care, and the patient died. This was published in the journal Open Forum Infectious Diseases as “Phage Therapy for a Multidrug-Resistant Acinetobacter baumannii Craniectomy Site Infection” (LaVergne 2018).

Lung infection

San Diego, CA

Patient4
Age67
GenderMale
Year2017
Phage RouteIV & Nebulizer
PathogenPseudomonas aeruginosa

Patient #4, a 67 year old male with a history of hypersensitivity pneumonitis and pulmonary fibrosis. He underwent bilateral lung transplantation in October 2016. His post-transplant course was complicated, including the development of two episodes of multidrug resistant Pseudomonas aeruginosa pneumonia. Bacteriophage therapy was administered via nebulizer and intravenously, along with adjunctive systemic antibiotics. Therapy was well tolerated without any attributable adverse events. Both episodes of pneumonia resolved, and the patient’s respiratory status improved. Patient was discharged from the hospital infection-free. This case is in the process of being submitted for publication to the Journal of Heart and Lung Transplantation as “Bacteriophage Therapy as an Adjunct to Systemic Antibiotics for Treatment of Multidrug Resistant Pseudomonas aeruginosa Pneumonia in a Lung Transplant Recipient” (Aslam 2018).

Lung infection

Pittsburgh, PA

Patient5
Age25
GenderFemale
Year2017
Phage RouteIV
PathogenBurkholderia cenocepacia

Patient #5, a 25 year old female with cystic fibrosis. She had a long history of multidrug resistant Burkholderia cenocepacia in her sputum. Despite her history, she was able to find a surgeon willing to perform a double lung transplant. Her post-transplant course was complicated by a re-emergence of the multidrug resistant Burkholderia cenocepacia in her blood, pneumonia and deteriorating respiratory status. The patient received two doses of intravenous bacteriophage therapy. She continued to decompensate over the next few hours and passed away due to progressive respiratory failure.

LVAD Infection

San Diego, CA

Patient6
Age60
GenderMale
Year2017
Phage RouteIV
PathogenPseudomonas aeruginosa

Patient #6, a 60 year old male with a left ventricular assist device infected with multidrug resistant Pseudomonas aeruginosa. His blood cultures were positive. He received 6 weeks of an intravenous bacteriophage mixture containing three phage. Phage was provided to the patient in four shipments. Drainage from the device became significantly less, and the patient eventually became culture negative. This case was a pioneer for the use of outpatient intravenous phage in the home without sequelae.

Osteomyletis

Jerusalem, Israel

Patient7
Age41
GenderMale
Year2018
Phage RouteIV
PathogenAcinetobacter baumannii & Klebsiella pneumoniae

Patient #7, a 41 year old male who sustained multiple traumas including the left knee. He developed a post-operative wound infection with multidrug resistant Klebsiella pneumoniae and Acinetobacter baumannii. A second muscle flap surgery was performed in a final attempt to save the patient’s leg. Following surgery, the patient received a two week course of intravenous bacteriophage therapy. His wound drainage became culture negative, and the muscle flap healed completely. He was discharged from the hospital and avoided above knee amputation.

Lung infection

Cleveland, OH

Patient8
Age28
GenderFemale
Year2018
Phage RouteIV
PathogenBurkholderia dolosa

Patient #8, a 28-year-old female with cystic fibrosis who developed a multidrug resistant Burkholderia dolosa infection in her lungs after having a bilateral lung transplant in early 2018. Despite multiple courses of antibiotics, the patient continued to deteriorate. Phage therapy was initiated in early September and additional doses were supplied in mid-September and early October. The patient’s bacterial titer dropped significantly, and the physician reported minor clinical improvements after 34 days of treatment. However, the patient suffered from an unrelated splenic pseudoaneurysm, and underwent a splenectomy and distal pancreatectomy at the end of October 2018. Despite a brief clinical hold, phage therapy was resumed in mid-November 2018. The patient’s physician reported that her infection had disseminated and decided to cease phage therapy in late November 2018. The patient was reported deceased late December 2018. 

Urinary Tract Infection & Bacteremia

Columbia, SC

Patient9
Age18
GenderFemale
Year2018
Phage RouteIV
PathogenEscherichia coli

Patient #9, an 18-year-old female who underwent a kidney transplant in March 2018 which prompted multiple episodes of bacteremia and urosepsis caused by an extended spectrum beta-lactamase (ESBL) producing strain of Escherichia coli. Phage therapy consisting of two different phage products with titers ranging from 1.0 x 10^9 to 1.0 x 10^10 PFU/mL was first administered intravenously in mid-September 2018. At this time the patient was still receiving standard of care antibiotics. The patient ended the course of antibiotics 15 days after start of phage therapy. The patient continued to received phage therapy. She was afebrile and showed marked clinical improvement after one week of treatment without antibiotics. The patient received phage therapy for a total of 23 days and was confirmed culture negative 11 days thereafter

Central Nervous System Infection

Rotterdam, Netheralands

Patient10
Age47
GenderMale
Year2018
Phage RouteIV
PathogenAcinetobacter baumannii

Patient #10, a 47-year-old male who suffered from significant head trauma after a motor vehicle accident. He was initially treated for a subdural hematoma, but soon after receiving surgery for facial fractures, he developed an abscess and ventriculitis caused by a multidrug resistant strain of Acinetobacter baumannii. The patient was in critical condition with dangerously high bacterial titers detected in his cerebral spinal fluid (CSF) prior to phage therapy. Treatment consisted of one phage strain administered intravenously starting in early November 2018. After 8 days of treatment, the patient’s CSF was culture negative for the MDR A. baumannii, however, he was culture positive for a strain of Klebsiella pneumoniae and Staphylococcus aureus. The patient’s physician reported brain death and announced deceased mid-November 2018.

Wound infection & Lung infection

Harefield, UK

Patient11
Age23
GenderMale
Year2018
Phage RouteIV
PathogenBurkholderia gladioli

Patient #11, a 23-year-old male with cystic fibrosis who developed a multidrug resistant Burkholderia gladioli infection in his chest cavity prior to a lung transplant in 2017. Since the transplant, the patient suffered from a sternal wound infection and recurrent bacteremia caused by the same bacterial pathogen. Phage therapy was initiated in early November 2018. The doctor reported marked clinical improvement after 11 days of treatment. After 35 doses of phage therapy, the patient had significant radiological improvement and was culture negative.  Patient is stable with significant clinical improvement of his sternal wound and has remained culture

Urinary Tract Infection

Syracuse, NY

Patient12
Age36
GenderMale
Year2019
Phage RouteIV & Intravesicular
PathogenEscherichia coli

Patient #12, a 36-year-old male who, due to a spinal injury, is an incomplete quadriplegic and has an ileal conduit. For over a year, he suffered from recurrent urinary tract infections (RUTI) and bacteremia caused by an extended spectrum beta-lactamase (ESBL) producing strain of Escherichia coli. His phage therapy began February consisted of two different phage products with titers between 1.0 x 10^8 and 7.0 x 10^ 8 PFU/mL. The treating physician administered the phage products twice daily intravenously during weekdays and directly into the patient's ileal conduit once per week. The patient began receiving antibiotics during their phage therapy to address sacral ulcer. At the doctor's request, therapy was stopped after 13 doses as the patient was now culture negative. The patient remained culture negative for two months but was readmitted into the hospital with reoccurring symptoms.

Lung infection

Columbia, SC

Patient13
Age10
GenderFemale
Year2019
Phage RouteIV
PathogenAchromobacter xylosoxidans

Patient #13, a 10-year-old female diagnosed with cystic fibrosis, who was admitted to the hospital for CF exacerbation with an Achromobacter xylosidans infection resistant to all available antibiotics. The patient was initially treated with the experimental antibiotic cefiderocol and 17 days later she began her phage therapy. During the first 5 days of phage therapy, the patient received both cefiderocol and phage. On the 5th day of the joint treatment the antibiotic regimen was stopped, and phage therapy continued. The patient received a single phage for therapy via IV with a titer of 2.35x10^9 PFU/mL and was released from hospital with significant clinical improvement.

Prosthetic joint infection

Rochester, MN

Patient14
Age61
GenderMale
Year2019
Phage RouteIV
PathogenKlebsiella pneumoniae

Patient #14, a 61-year-old male who suffers from bilateral knee osteoarthritis. In 2008, the patient had a right TKA which was complicated by several infections between 2009-2018 (treated with I & D and intensive antibiotic regimen), which lead to a spacer removal and replacement of the distal femoral modular component within the knee in 2019. At the site of surgery, his right knee became infected with an MDR, Klebsiella pneumoniae. The patient received 6 weeks of phage therapy via IV at a titer of 5e10 and ~20 EU/mL and experimental antibiotic cefidericol. The swelling seen at the site of infection dramatically decreased after the first infusion and at the end of therapy the patient had significant improvements in mobility, and blood testing results. Sensitivity testing showed that the bacterial isolate had developed resistance to the experimental antibiotics during therapy.

Osteomyletis

Jerusalem, Israel

Patient15
Age46
GenderMale
Year2019
Phage RouteIV
PathogenPseudomonas aeruginosa

Patient #15, a 46-year-old male who had multiple trauma 25 years ago during his service in the military. During this time, he had multiple prolonged admissions to the hospital where he eventually developed Pseudomonas aeruginosa osteomyletis in his left tibia. The most recent imaging at the site of infection suggested that the P. aeruginosa had spread up and down from original site. Patient received 2 weeks of phage therapy at titer of 1.3e11 PFU/ml, at 170 EU/mL and ceftazidime. Patient was released from the hospital with reduced lymphocyte count, and mild elevation of CRP.

Wound infection

Baltimore, MD

Patient16
Age45
GenderFemale
Year2019
Phage RouteIV
PathogenAcinetobacter baumannii & Klebsiella pneumoniae

Patient #16, a 45-year-old woman who underwent a liver transplant leading to septic shock from intra-abdominal infection. She underwent liver transplantation in April 2019 which was complicated by delayed closure, biliary leak, peritonitis, and ischemic bowel s/p multiple resections. Her abdomen was closed using mesh which developed DIC and bleeding. This infection was colonized with Pseudomonas aeruginosa, Klebsiella pneumoniae and Enterococcus faecium. The VRE was addressed with an antibiotic regimen and the patient received two phage P. aeruginosa and Klebsiella. The patient had noticeable improvement after the first few doses of the P.aeruginosa phage, but this improvement was overshadowed after the administration of the second phage. Observed phage interactions within the HRQT suggests that the K. pneumoniae phage inhibited the P.aeruginosa phage from attacking the patient bacteria. The patient was moved to comfort care after she suffered multiple system organ failure.

Prosthetic joint infection

San Diego, CA

Patient17
Age61
GenderFemale
Year2019
Phage RouteIV & IA
PathogenStaphylococcus aureus

Patient # 17 is a 61-year-old female with a chronic, persistently infected right prosthetic knee joint infection with methicillin-sensitive S. aureus (MSSA) present since Dec 2017. It remained infected with draining sinuses despite multiple rounds of IV antibiotics and surgeries. She received two weeks of phage therapy IV twice a day provided by another company and clinically responded. However, a few weeks after stopping phage her infection recurred and this company was not able to supply additional phage. The patient had since developed anti-phage neutralizing antibodies which neutralized 4 APT phage candidates. At the time of surgical debridement, hardware removal, and antibiotic spacer placement on 25September, 2019 and received an intra-operative dose of a single lytic phage. Multiple surgical cultures (surgical) were positive for MSSA. The patient continued and tolerated twice daily IV phage for 4 weeks using this phage and conducted home installation without adverse event. She responded clinically to combined phage and antibiotic therapy and experience a reduction in inflammatory markers (ESR, CRP). However, she subsequently developed recurrent swelling of the right knee for which she underwent aspiration of the knee joint. Synovial fluid was culture negative on 1Nov2019 and had minimal inflammatory cells. Phage was discontinued on 6Nov2019 and IV cefazolin was continued. She was admitted for a fall on November 17, 2019 and was diagnosed with a right hip fracture which required an open reduction and internal fixation. Her right knee was also more swollen and painful since the fall and synovial fluid analysis on 17Nov2019 showed 25,000 WBC/mL with 92% polymorphonuclear cells. On November 22, 2019 her physician reported that the S. aureus infection had cleared but the synovial fluid from the same knee was now culture positive for pan-susceptible P. aeruginosa. The patient received IV cefepime for the P. aeruginosa infection, though the treating physician requested a P. aeruginosa phage for treatment as well. The first dose was administered on February 12th intra-op followed by twice daily IV installations for one week. All her surgical cultures from 12Feb2020 were negative. No adverse events were reported during the treatment.

Prosthetic joint infection

Baltimore, MD

Patient18
Age71
GenderMale
Year2019
Phage RouteIV & IA
PathogenStaphylococcus aureus

Patient #18, a 71-year-old male with a morbid obesity (BMI 41) and hyperlipidemia presented with a chronic MRSA PJI. Twenty years prior he had a methicillin sensitive Staphylococcus aureus (MSSA) septic arthritis and intraosseous abscess of his right knee that was treated with intravenous (IV) cefazolin. One year later, he fractured his distal right femur, requiring open reduction and internal fixation with a lateral plate. He developed severe osteoarthritis over the subsequent decade, had a right knee arthroplasty in 2012 and a Staphylococcus epidermidis right knee PJI in 2014 which required debridement, antibiotics, and implant retention (DAIR), an a subsequent 2-stage revision. After a fall in 2016, he developed an MRSA infection and underwent two DAIR procedures. Multiple antibiotics were administered and he was transitioned to chronic oral doxycycline therapy. Once this was discontinued, his infection recurred and repeat arthrocentesis culture grew MRSA. Despite resumption of doxycycline, symptoms worsened. Since his distal femur fracture had healed poorly, a standard 2 stage revision was deemed not feasible and the patient refused amputation. Instead, he had a DAIR with IA and IV bacteriophage therapy. Intraoperatively, numerous sinus tracts, gross purulence, and extensive soft tissue infection were present. Extensive erosion of the distal femoral bone stock was present, and gross loosening of the prosthesis was evident. Therefore, prosthesis could not be salvaged. Explant of prosthesis components with placement of static vancomycin and tobramycin spacer was conducted. To allow for femoral reconstruction, clearance of the extensive MRSA infection was required. After surgery, he received two doses of IA bacteriophage, IV daptomycin and was started on daily phage therapy the next day. After the third IV dose of bacteriophage, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) increased to 136 and 86. The next day, AST and ALT were 692 and 462 and bacteriophage therapy was discontinued. Bilirubin, PT/INR, alkaline phosphate, and creatine kinase remained normal. Albumin decreased to 2.7 from baseline of 3.6, as had occurred with his numerous previous surgeries. Daily cumulative doses of Tylenol were less than 1.5 grams. Hepatitis A, B, and C serologies were negative. Tests for influenza, adenovirus, parainfluenza, enterovirus, RSV, EBV, CMV, mycoplasma, chlamydia, and coronavirus were negative. Ultrasound showed hepatomegaly, but no ductal or other abnormalities were seen. AST and ALT decreased to normal 10 days later. CRP trended to normal 14 days after surgery. IV daptomycin was continued for 6 weeks, and then antibiotics were stopped. Three weeks off antibiotics, the patient underwent a second debridement surgery to confirm clearance of infection and had resection of the grossly malunited distal femur fracture and heterotopic bone. Another static vancomycin spacer was inserted. No infection was seen operatively, but another IA bacteriophage dose was given. Eight cultures from soft tissues, femoral canal, and devitalized bone were all negative. Daily monitoring for 5 days showed no elevations in AST or ALT. Two months later, after optimization of BMI, implantation of a cemented distal femoral megaprosthesis was performed off antibiotics. Given the severity of the previous infection, an additional IA bacteriophage dose was given. Intraoperative cultures were again negative. No elevations in AST or ALT were observed. One week later, the patient was discharged to receive rehabilitation to strengthen his right lower extremity.

Osteomyletis

Sydney, Australia

Patient19
Age7
GenderFemale
Year2019
Phage RouteIV
PathogenPseudomonas aeruginosa

Patient #19, a 7-year-old female who sustained multiple injuries from a MVA in 2018. This accident led to a long hospital admission and multiple surgical interventions with metal hardware (bilaterally, from hips down) ultimately resulting in chronic multidrug resistant P. aeruginosa osteomyelitis of the left foot. Her physicians sought out phage therapy since futher surgery might destabilize the ankle joint resulting in amputation. Patient completed 2 weeks of therapy with a single phage. Two weeks after discharge her physician reported healing at the site of infection and increased mobility.

LVAD Infection

Jerusalem, Israel

Patient20
Age10
GenderFemale
Year2019
Phage RouteIV
PathogenPseudomonas aeruginosa

Patient #20 was a 10 year-old female with an inherited genetic dilated cardiomyopathy and had a Berlin heart inserted in January 2019. She had a prolonged hospital course that included colonization with Klebsiella pneumoniae and Pseudomonas aeruginosa, Clostridum difficile toxin-associated colitis and almost persistent bacteremia with P. aeruginosa. She recieved seven weeks of a single bacteriophage therapy intravenously and meropenem. She had a decline in her health while on treatment and experineced high fevers and decreased level of consciousness and both phage ane merepenem were discontinued. Alhough her daily cultures were negative and inflammatory markers remained within normal limits, phage and meropenem therapy was stopped due to high fever and major reduction in neurological response. After discontinuation of therapy, her cultures were positive for MDR P. aeruginosa and had the same antibiotic susceptibilities as her original cultures. Due to low consciousness level, with no known source of her resistant infection, failure to gain weight and tolerate feeds, her parents asked to discontinue suportive therapy and she passed away in January 2020.

Mastoiditis

Jerusalem, Israel

Patient21
Age69
GenderMale
Year2020
Phage RouteIV
PathogenPseudomonas aeruginosa

Patient #21, a 69 year-old male with a history of ischemic heart disease and non-insulin-dependent diabetes mellitus.  He was admitted in November 2019 with malignant otitis and mastoiditis on his left ear due to Pseudomonas aeruginosa. The patient was discharged on Dec 1st and readmitted with the same issue on Dec 8th suggesting failure on antibiotics.  On Dec 19th, he had a left radical mastoidectomy. Antibiotics were started postoperatively and phages were added 2 days later. Phages were given intravenously for 2 weeks and ceftazidime was administered for 6 weeks. No adverse events were observed during therapy and his treatment provided a good response. During a follow visit on 26Jan2020 he was noted to have good closure of the surgical wound.

LVAD Infection & Prosthetic joint infection

Columbia, SC

Patient22
Age69
GenderFemale
Year2020
Phage RouteIV
PathogenPseudomonas aeruginosa

Pateint #22, a 69 year-old woman with a past medical history of chronic kidney disease, hypothyroidism, severe congestive heart failure with reduced ejection fraction, prosthetic knee joint infection, and a history of bacteremia. In November 2016, she had a left ventricular assist device (LVAD) placed and a right knee arthroplasty. Over a 4 year period she developed multiple infections of her LVAD driveline and prosthetic joint infections ressistant to multiple antibiotics. In June 2019 she had a right knee incision and drainage procedure and a 1-stage revision. Her LVAD driveline was also debrided, she was discharged to rehabilitation on ceftolozane-tazobactam for a P. aeruginosa in her drive line and right knee and oral amoxicillin for E. faecalis in her drive line. Meropenem was added in June 2019 because her driveline isolate was resistant to ceftolozane-tazobactam. She had recurrent P. aeruginosa bacteremia in December 2019 after stopping ceftolozane/tazobactam (by her choice) in November 2019. These P. aeruginosa isolates had similar susceptibilities to those isolated in June 2019. Three P. aeruginosa isolates (from blood, right knee and drive line) were tested for phage susceptibility. Two matching phage were provided in February 2020 and the patient received her first phage intravenously along with ceftolozane/tazobactam and oral amoxicillin. Her C-reactive protein levels fell from 61 to 31.7 over her 3 weeks and her erythocyte sedimentation rate decreased from 104 to 89. Her LFTs were normal during most of her phage therapy, although she was noted to slightly increase in March 2020. Soreness in her knee joint decreased during her four weeks phage course. She was able to walk more on her knee and has had minimal driveline drainage. This case is ongoing.

Graft Infection

Bronx, NY

Patient23
Age73
GenderMale
Year2020
Phage RouteIV & IV
PathogenKlebsiella pneumoniae

Patient #23, a 73 year-old male with Type 2 diabetes mellitus, hypertension and severe peripheral vascular disease including a left femoral-popliteal bypass with vascular graft, left superior femoral artery and popliteal atherectom, left femoral profunda endarterectomy with patch angioplasty, left lower superior femoral artery stent and right femoral to left popliteal bypass. In January 2020, his surgical wounds broke down at both right femoral and left popliteal incisions. The wounds were noted to be non-purulent with sinus tracts probing to graft. Culture at both sites grew carbapenem resistant Klebsiella pneumonia and he also had a pseudoaneurysm at the right femoral anastomosis. Blood cultures were negative and there was no fever or leukocytosis. He was treated with multiple antibiotics from 17January to 4March, 2020. Exgraftment of the infected graft was considered with axillary-femoral graft bypass but patient refused this procedure. Even if he had accepted to undergo the procedure, the new graft would have had to be placed into an infected wound bed. Instead, he underwent a right femoral exploration with sartorius muscle flap closure to reduce the risk of spontaneous rupture of the pseudo-aneurysm. In January 2020, he was found to have new cardiomyopathy with severely reduced ejection fraction. The patient was told that the likelihood of cure with antibiotics alone was remote. He was treated with phage therapy (19 doses) starting on 2March, 2020. No adverse events were reported during treatment. In April 2020 he was noted to have left leg gangrene of first and second toe and occlusion of left common iliac artery. Despite these complications, he has reported no fevers or other signs and symptoms of systemic infection. He was also found to have greenish discharge from his left popliteal wound which was open since his initial evaluation in January 2020 and healing of his right groin wound. In May 2020, he had worsening pain in left foot and left calf which has prevented him from walking or sleeping well. At this point, the culture obtained in April showed Pseudomonas aeruginosa and was admitted for IV antibiotics and clearance for surgery. Cefepime was initiated from admission and continued to date. Due to his cardiac risks, he was transferred to another hospital for cardiac optimization before proceeding with the left above-knee-amputation. During this admission, he remained afebrile, without leukocytosis or other signs and symptoms of systemic infection. He is scheduled for vascular surgery and this case is ongoing.

Prosthetic joint infection

Rochester, MN

Patient24
Age34
GenderFemale
Year2020
Phage RouteIA
PathogenStaphylococcus aureus

Patient 24, a 39-year-old female with giant cell tumor of the right distal femur treated with distal femur replacement in 2016. She developed arthrofibrosis and underwent revision in December, 2018 and developed an methicillin sensitive Staphylococcus aureus (MSSA) infection which necessitated debridement, antibiotics and implant retention (DAIR) in January, 2019. She received multiple antibiotics due to intolerability. MSSA was again isolated during a second DAIR procedure in January 2020 and she required a third DAIR procedure in January 2020. She developed increased right leg pain and night sweats in March 2020 and an increase in inflammatory markers. Phage therapy was considered as a way to mitigate the infection and possibly thwart additional surgery (resection arthroplasty which would be highly disruptive and morbid). Aspiration of the right knee on 4/3/20 showed a WBC of 10,000 per cubic millimeter with 89% neutrophils and the culture was positive for MSSA. She was started on phage therapy on 4/3/20. She received a double dose IA and daily IV dosing. She did well clinically and reported 0 out of 10 pain. She is scheduled for repeat aspiration and the case is ongoing.

Prosthetic joint infection

Rochester, MN

Patient25
Age61
GenderMale
Year2020
Phage RouteIV & IA
PathogenStaphylococcus epidermidis

Patient 25, a 61 year-old male who had a primary left total hip arthroplasty in 1985 which required revisions in 1991, 2000, and 2004 complicated by infection with staphylococcus. He failed debridement, antibiotics and implant retention (DAIR) and required a two-stage exchange in 2004-2005 for Enterococcus cloacae, followed by further surgical interventions in 2008 (staphylococcus epidermidis), 2010 (staphylococcus epidermidis), 2013 with exchange of modular head due to a MSSA infection, and in 2014 with exchange of acetabular liner and modular head with insertion of antibiotic-impregnated cement due to a Enterobacter cloacae. infection. In 2016, he developed a Candida albicans infection while on chronic suppression with both minocycline and levofloxacin and had a second DAIR and on antibiotic suppressive treatment including fluconazole. In 2019, he developed a left lateral thigh fluid collection which was aspirated and grew minocycline-susceptible coagulase-negative staphylococci. He underwent a third DAIR in June 2019 and was maintained on chronic suppressive antimicrobial therapy. Despite this, the patient developed re-accumulation of fluid. Because of insufficient femoral bone stock, the only remaining surgical options were total femoral replacement done in stages which is highly morbid and unlikely to successfully eradicate the infection versus hip disarticulation. Since he had exhausted reasonable surgical and medical interventions, he was evaluated for phage therapy and the collection was aspirated (1 liter of bloody fluid) in April, 2020 which yielded a positive culture for oxacillin-resistant Staphylococcus epidermidis. Phage therapy was started intra-articularly (single dose) and daily intravenous doses x 10 days. He was maintained on levofloxacin, minocycline, and fluconazole. He did well clinically with minimal pain (this is baseline). A repeat aspiration is planned and the case is ongoing.

Prosthetic joint infection

Rochester, MN

Patient26
Age60
GenderMale
Year2020
Phage RouteIV & IA
PathogenStaphylococcus aureus

Patient 26, a 60-year-old man with multiple medical comorbidities including a thoracic aortic aneurysm, atrial fibrillation status post ablation, gastric bypass surgery 2014 complicated by postop gastric sleeve strictures requiring stenting, history of DVT, and multiple joint arthroplasties including bilateral total knee arthroplasty, total hip arthroplasty (THA) and total shoulder arthroplasty. He underwent primary left total hip arthroplasty on May 27, 2014 which was complicated by methicillin resistant Staphylococcus aureus (MRSA) bacteremia and prosthetic joint infection (PJI) in 2015 and treated with debridement, antibiotics, and implant retention (DAIR) followed by chronic antibiotic suppression, which he had significant difficulty tolerating. He had a subsequent left THA revision in 2018 due to a fracture after a fall and this was complicated by recurrent infection with cultures positive for MRSA and group B strep and he underwent a repeat revision. He had continued difficulty tolerating both IV abx (daptomycin) as well as bactrim/penicillin for chronic suppression. He developed loosening of the components in late 2018. Discussions were had about possibly performing a girdlestone procedure but due to significant anticipated loss of function, this was delayed. A repeat left THA aspiration in Feb 2020 cultured MRSA. Since then he had been having intermittent fevers despite suppression with Bactrim and penicillin VK. He had two hospital admissions in February 2020 and March 2020 with drainage, erythema, fevers, and rigors, and chest pain and was wheelchair bound. The patient had multiple medical complications and did poorly with 9 or 10 out of 10 pain, intermittent fevers and chills, inability to bear weight on left leg and copious and constant brown drainage. In April, 2020 he had a DAIR procedure and received 1 dose of phage intraoperatively. His (pre-phage) intra-operative cultures were positive for MRSA and was placed on vancomycin and rifampin. He received a double dose of IA phage the next day and received ten daily (single dose) IV doses over 14 days. He did well clinically, and all drainage stopped. Re-aspiration of the joint is planned and the case is ongoing.

 

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