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

NCT ID: NCT03970200

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-16
• Study Completion Date: 2022-05-14

Brief 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).

Conditions

Severe Clostridium Difficile Infection; Severe-Complicated/Fulminant Clostridium Difficile Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No investigational product

Participants who receive the antibiotics usually prescribed for C diff infection.

Group Type: ACTIVE_COMPARATOR

Antibiotics

Intervention Type: DRUG

Standard of care antibiotics

Upper gastrointestinal Fecal Microbiota Transplantation

Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor

Group Type: EXPERIMENTAL

Penn Microbiome Therapy - 002

Intervention Type: DRUG

Fecal Microbiota for Transplant, suspension product

Penn Microbiome Therapy - 003

Intervention Type: DRUG

Fecal Microbiota for Transplant, capsule product

Antibiotics

Intervention Type: DRUG

Standard of care antibiotics

Lower gastrointestinal Fecal Microbiota Transplantation

Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).

Group Type: EXPERIMENTAL

Penn Microbiome Therapy - 001

Intervention Type: DRUG

Fecal Microbiota for Transplant, enema product

Antibiotics

Intervention Type: DRUG

Standard of care antibiotics

Interventions

Penn Microbiome Therapy - 001

Fecal Microbiota for Transplant, enema product

Intervention Type: DRUG

Penn Microbiome Therapy - 002

Fecal Microbiota for Transplant, suspension product

Intervention Type: DRUG

Penn Microbiome Therapy - 003

Fecal Microbiota for Transplant, capsule product

Intervention Type: DRUG

Antibiotics

Standard of care antibiotics

Intervention Type: DRUG

Other Intervention Names

PMT-001; PMT-002; PMT-003

Eligibility Criteria

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
• b. Hypotension with systolic blood pressure sustained < 90mmHg for three or more hours or requiring vasopressors (epinephrine, norepinephrine, phenylephrine, or vasopressin)
• c. Acute kidney injury - increase in serum creatinine level by ≥50% or new dialysis initiation
• i. If a baseline serum creatinine value is not available, acute kidney injury will be defined as a serum creatinine >1.5 mg/dL
• d. Temperature ≥38.5 °C or <35.6°C - one value needed in time period -
• e. Ileus, bowel dilation or megacolon
• i. Ileus: If noted in any provider documentation or problem list (search words "ileus") OR
• ii. If the words "dilated" "dilation" or "ileus" are noted in a radiology report on intestines/colon, or if "megacolon" noted
• f. Lactate >2.2 mmol/L - if any value in the time period meets this definition
• g. Systemic inflammatory response syndrome(SIRS) criteria
• i. Heart rate > 90 beats per minute
• ii. Respiratory rate > 20 breaths per minute or PaCO2 < 32 mmHg
• iii. Temperature >38ºC or <36ºC
• iv. WBC > 12,000 cells/uL, <4,000 cells/uL, or >10% immature (band) forms

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ebbing Lautenbach, MD, MPH, MSCE

Role: PRINCIPAL_INVESTIGATOR

Division of Infectious Diseases, Department of Medicine, University of Pennsylvania

Locations

Hospital of the Univeristy of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB # 832962

Identifier Type: -

Identifier Source: org_study_id