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Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)

A Phase II, Randomized Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Severe or Severe-Complicated/Fulminant Clostridium Difficile Infection

NCT03970200•University of Pennsylvania

View on ClinicalTrials.gov

Summary

This is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. One or more episodes of CDI with symptoms including bowel movements altered in frequency or consistency from baseline.
•2\. Stool test positive for Clostridium difficile by enzyme immunoassay (EIA) by FDA-cleared assay within 7 days prior to enrollment.
•3\. Age ≥ 18 years
•4\. Meets any one of the listed criteria for severe or severe-complicated/fulminant disease within 72 hours of enrollment.
•5\. Receiving antibiotic treatment for S/SC(Severe-complicatedcategory)/F-CDI per current Infectious Diseases Society of America(IDSA) guidelines.
•Enrollment criteria details:
•1\. Must either meet ≥1 criteria in severe category or in severe complicated category to be enrolled
•2\. If the subject meets criteria in both categories, stratify to the higher severity category (severe complicated)
•3\. Detailed enrollment criteria definitions:
•a. white blood cells (WBC) ≥15,000 cells/uL - if any value in the time period meets this definition
+13 more criteria

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 Receipt of Fecal Microbiota Transplantation (FMT) or enrollment in a clinical trial for FMT within the last 3 months.
•7 COVID-19 infection, as defined by a positive nucleic acid or antigen test within the prior 14 days and symptoms consistent with COVID-19 infection

Locations (1)

Hospital of the Univeristy of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

January 16, 2020

Primary Completion Date

November 21, 2021

Completion Date

May 14, 2022

Last Updated

October 30, 2023

Enrollment

ACTUAL participants

Conditions

Severe Clostridium Difficile InfectionSevere-Complicated/Fulminant Clostridium Difficile Infection

Interventions

Penn Microbiome Therapy - 001

DRUG

Penn Microbiome Therapy - 002

DRUG

Penn Microbiome Therapy - 003

DRUG

Antibiotics

DRUG