PMT for MDRO Decolonization
Multidrug Resistant Bacterial Infection, Enterobacteriaceae Infections, Pseudomonas Aeruginosa
About this trial
This is an interventional treatment trial for Multidrug Resistant Bacterial Infection
Eligibility Criteria
Inclusion Criteria: Multidrug-resistant organism (MDRO) infection of the bloodstream, respiratory tract, or urinary tract. Qualifying MDROs include extended-spectrum cephalosporin-resistant Enterobacterales (ESCRE) or carbapenem-resistant Enterobacterales (CRE), Pseudomonas aeruginosa resistant to two or more classes of antibiotics (MDR-PA), vancomycin-resistant Enterococcus (VRE), and methicillin-resistant Staphylococcus aureus (MRSA). On appropriate antibiotic treatment per clinical phenotypic susceptibility testing of the qualifying MDRO, and with a qualifying antibiotic class. Qualifying antibiotic classes include beta-lactam + beta-lactamase inhibitor, carbapenem (with or without betalactamase inhibitor), fluoroquinolone, lipopeptide, glycopeptide, or oxazolidinone. Expected duration of inpatient antibiotic treatment for index MDRO infection at least 5 days total. At least two calendar days remaining, and no more than 7 calendar days remaining prior to planned completion of antibiotic treatment for index MDRO infection. Age ≥ 18 years. 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 (ANC < 1000 cells/uL) or severe (ANC < 500 cells/uL) neutropenia. Known food allergy that could lead to anaphylaxis. Known allergy to fecal microbiota transplant products or their components Pregnancy or lactation For subjects of childbearing potential (ages 18 to 55) and who are randomized to receive the intervention, the subject must have a negative pregnancy test within 24 hours prior to product administration Female or male subjects (ages 18 to 55) of reproductive potential engaged in active sexual activity that could lead to a pregnancy must agree to use one of the following forms of birth control while receiving study medications and through day 28 following completion of treatment, at minimum: 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: Inflammatory Bowel Disease (IBD) Short Gut Syndrome Fistulas Bowel resection surgery Colitis
Sites / Locations
- Hospital of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Arm 19
Arm 20
Arm 21
Arm 22
Arm 23
Arm 24
Experimental
No Intervention
Experimental
No Intervention
Experimental
No Intervention
Experimental
No Intervention
Experimental
No Intervention
Experimental
No Intervention
Experimental
No Intervention
Experimental
No Intervention
Experimental
No Intervention
Experimental
No Intervention
Experimental
No Intervention
Experimental
No Intervention
ESCRE/CRE BL-BLI
ESCRE/CRE BL-BLI standard of care (SOC)
ESCRE/CRE carbapenem +/- BLI
ESCRE/CRE carbapenem +/- BLI standard of care (SOC)
ESCRE/CRE Fluoroquinolone
ESCRE/CRE Fluoroquinolone standard of care (SOC)
MRSA lipo/glycopeptide
MRSA lipo/glycopeptide standard of care (SOC)
MRSA oxazolidinone
MRSA oxazolidinone standard of care (SOC)
MDR-PA BL-BLI
MDR-PA BL-BLI standard of care (SOC)
MDR-PA carbapenem +/- BLI
MDR-PA carbapenem +/- BLI standard of care (SOC)
MDR-PA Fluoroquinolone
MDR-PA Fluoroquinolone standard of care (SOC)
VRE lipopeptide
VRE lipopeptide standard of care (SOC)
VRE oxazolidinone
VRE oxazolidinone standard of care (SOC)
ESCRE/CRE cefepime/cefidericol
ESCRE/CRE cefepime/cefidericol standard of care (SOC)
MDR-PA cefepime/cefidericol
MDR-PA cefepime/cefidericol standard of care (SOC)
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI)
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) standard of care (SOC)
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: carbapenem +/- BLI standard of care (SOC)
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone
MDRO: extended-spectrum cephalosporin resistant Enterobacterales ESCRE/CRE Antibiotic Class: Fluoroquinolone standard of care (SOC)
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: lipo/glycopeptide standard of care (SOC)
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone
MRDO: methicillin-resistant S. aureus (MRSA) Antibiotic Class: oxazolidinone standard of care (SOC)
MDRO: two-class resistant Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI)
MDRO: two-class resistant Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Beta Lactamase Inhibitors (BL-BLI) standard of care (SOC)
MDRO: two-class resistant Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI
MDRO: two-class resistant Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: carbapenem +/- BLI standard of care (SOC)
MDRO: two-class resistant Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone
MDRO: two-class resistant Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: Fluoroquinolone standard of care (SOC)
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: lipopeptide standard of care (SOC)
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone
MDRO: vancomycin resistant Enterococcus (VRE) Antibiotic Class: oxazolidinone standard of care (SOC)
MDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol
MDRO: ESCRE/CRE Antibiotic Class: cefepime/cefidericol standard of care (SOC)
MDRO: two-class resistant Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol
MDRO: two-class resistant Pseudomonas aeruginosa (MDR-PA) Antibiotic Class: cefepime/cefidericol standard of care (SOC)