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This is a randomized, open label, comparative Phase II trial being conducted to determine whether fecal microbiota transplant using Penn Microbiome Therapy (PMT) products helps standard therapy eradicate antibiotic-resistant bacteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESCRE/CRE BL-BLI | Experimental | MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) |
|
| ESCRE/CRE BL-BLI standard of care (SOC) | No Intervention | MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) standard of care (SOC) | |
| ESCRE/CRE carbapenem +/- BLI | Experimental | MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI |
|
| ESCRE/CRE carbapenem +/- BLI standard of care (SOC) | No Intervention | MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI standard of care (SOC) | |
| ESCRE/CRE Fluoroquinolone | Experimental | MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone |
|
| ESCRE/CRE Fluoroquinolone standard of care (SOC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMT | Drug | Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with resolution of index MDRO colonization of the gut | measured by selective stool culture, resolution will be defined as the absence of growth of the index MDRO on selective culture media. | 30 (+/-7)- day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) |
| Frequency of solicited adverse events (AEs) | randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) | |
| Frequency of serious adverse events (SAEs) | randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) | |
| Frequency of adverse events of special interest (AESIs) | randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) | |
| Frequency of medically attended adverse events (MAAEs) | randomization until 180 day visit after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication of gut colonization with the index MDRO | i.e., negative selective bacterial culture for the index MDRO to be assessed in addition to primary endpoint | 7 days and 90 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) |
| Eradication of gut colonization with any of the included MDROs |
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Inclusion Criteria:
Exclusion Criteria:
Evidence of colon/small bowel perforation at the time of study screening.
Unable to tolerate enteral and enema nutrition and medication administration (i.e., only able to tolerate intravenous nutrition and medications).
Goals of care are directed to comfort rather than curative measures.
Moderate or severe neutropenia within 10 calendar days prior to enrollment.
Known food allergy that could lead to anaphylaxis.
Known allergy to fecal microbiota transplant products or their components
Pregnancy or lactation
i. Male or female condoms
ii. Diaphragm or cervical cap with spermicide, if available
iii. Intrauterine device (IUD)
iv. Oral contraceptives or other hormonal contraception
Known gastrointestinal disease that could affect the safety of fecal microbiota transplant at time of enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| Brendan J Kelly | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University - Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Washington University |
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| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Randomized, open label, comparative
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| No Intervention |
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone standard of care (SOC) |
| MRSA lipo/glycopeptide | Experimental | MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide |
|
| MRSA lipo/glycopeptide standard of care (SOC) | No Intervention | MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide standard of care (SOC) |
| MRSA oxazolidinone | Experimental | MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone |
|
| MRSA oxazolidinone standard of care (SOC) | No Intervention | MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone standard of care (SOC) |
| MDR-PA BL-BLI | Experimental | MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) |
|
| MDR-PA BL-BLI standard of care (SOC) | No Intervention | MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) standard of care (SOC) |
| MDR-PA carbapenem +/- BLI | Experimental | MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI |
|
| MDR-PA carbapenem +/- BLI standard of care (SOC) | No Intervention | MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI standard of care (SOC) |
| MDR-PA Fluoroquinolone | Experimental | MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone |
|
| MDR-PA Fluoroquinolone standard of care (SOC) | No Intervention | MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone standard of care (SOC) |
| VRE lipopeptide | Experimental | MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide |
|
| VRE lipopeptide standard of care (SOC) | No Intervention | MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide standard of care (SOC) |
| VRE oxazolidinone | Experimental | MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone |
|
| VRE oxazolidinone standard of care (SOC) | No Intervention | MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone standard of care (SOC) |
| ESCRE/CRE cefepime/cefidericol | Experimental | MDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol |
|
| ESCRE/CRE cefepime/cefidericol standard of care (SOC) | No Intervention | MDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol standard of care (SOC) |
| MDR-PA cefepime/cefidericol | Experimental | MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol |
|
| MDR-PA cefepime/cefidericol standard of care (SOC) | No Intervention | MDRO: two-class non-susceptible Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol standard of care (SOC) |
|
| 7- , 30-, and 90-days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) |
| All-cause mortality | 30- and 60-days following SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) |
| Colectomy occurrence | within 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) |
| Cumulative days of hospitalization | from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) |
| Cumulative days of intensive care | from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) |
| Bacteria growth in blood samples | from randomization to 30 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) |
| Hospital admission | within 60 days of discharge from index hospitalization |
| Hospital admission | within 180 days after SCAIM (scheduled completion of appropriate inpatient antibiotics for the index MDRO infection) |
| Instances of worsened abdominal pain, fever, tachycardia, and hypotension | randomization until 180-day visit |
| Instances of aspiration (including reduced oxygen saturation, tachypnea, or respiratory distress (PMT-002 upper entral delivery only) | randomization until 180-day visit |
| Instances of fever, diarrhea, nausea and vomiting | 7-, 30-, 90- and 180 day follow up visits |
| Instances of new metabolic disease, including hyperglycemia, thyroid disease, weight gain or loss | 30-, 90- and 180 day follow up visits |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |