Clinical trial NCT03973697: Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection
Official title: A Phase II, Randomized Trial to Evaluate the Optimal Dosing of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Recurrent Clostridium Difficile Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Recurrent Clostridium Difficile Infection
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open label, comparative
Primary purpose: TREATMENT

Brief summary: This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).


Eligibility criteria: Inclusion Criteria:

1. Second or greater episode of CDI (first or greater recurrence) within 12 months, with symptoms including bowel movement altered in frequency or consistency from baseline.
2. Stool positive for C. difficile toxin by EIA or toxin gene by NAAT within 60 days of enrollment.
3. At least one additional prior positive stool test for C. difficile within the prior 12 months (EIA or NAAT as above).
4. Age ≥ 18 years.
5. Minimum of 72 hours of receipt of standard-of-care (vancomycin or fidaxomicin) antibiotic treatment for R-CDI prior to intervention.

Exclusion Criteria:

1. Evidence of colon/small bowel perforation at the time of study screening
2. Goals of care are directed to comfort rather than curative measures.
3. Moderate (ANC \< 1000 cells/uL) or severe (ANC \< 500 cells/uL) neutropenia.
4. Known food allergy that could lead to anaphylaxis.
5. Pregnancy

   a. For subjects of childbearing potential (ages 18 to 55), the subject must have a negative urine pregnancy test within 48 hours of consent and no more than 48 hours prior to first product administration
6. Meeting criteria for severe, severe-complicated/fulminant CDI within 24 hours of planned trial enrollment. We define severe or severe-complicated/fulminant CDI as any one of the following: (1) leukocytosis with peripheral WBC ≥ 15,000 cells/mL; (2) hypotension with systolic blood pressure sustained \< 90mmHg for three or more hours or requiring pressors; (3) provider documentation of ileus or radiologic evidence of bowel dilation or megacolon; (4) acute kidney injury with increase in baseline serum creatinine level by ≥50% or new dialysis initiation; (5) serum lactate \> 2.2 mmol/L; or (6) ≥ 3 systemic inflammatory response syndrome (SIRS) criteria (which include heart rate \> 90 beats per minute, respiratory rate \> 20 breaths per minute or PaCO2 \< 32 mmHg, temperature \>38ºC or \<36ºC, WBC \> 12,000 cells/uL, \<4,000 cells/uL, or \>10% immature (band) forms).
7. Receipt of FMT or enrollment in a clinical trial for FMT within the last 3 months.

Primary outcomes:
measure: Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control.
timeFrame: 8 weeks
Secondary outcomes:
measure: All-cause Mortality at 30-days Following Last FMT
timeFrame: 30 days
measure: All-cause Mortality at 60-days Following Last FMT
timeFrame: 60 days
measure: Colectomy or Diverting Ileostomy Within 30 Days After Last FMT
timeFrame: 30 days
measure: Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT
timeFrame: 30 days
measure: Cumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT
timeFrame: 30 Days
measure: Bacteremia From Enrollment Until 30 Days After Last FMT
timeFrame: 30 days
measure: Hospital Admission Within 60 Days of Discharge From Index Hospitalization
timeFrame: 60 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the Univeristy of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ebbing Lautenbach, MD, MPH, MSCE
role: PRINCIPAL_INVESTIGATOR
References: