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Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

Primary Purpose

Recurrent Clostridium Difficile Infection

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Penn Microbiome Therapy - 001

Penn Microbiome Therapy - 002

Penn Microbiome Therapy - 003

About this trial

This is an interventional treatment trial for Recurrent Clostridium Difficile Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Stool positive for C. difficile toxin by EIA or toxin gene by NAAT within 60 days of enrollment.
At least one additional prior positive stool test for C. difficile within the prior 12 months (EIA or NAAT as above).
Age ≥ 18 years.
Minimum of 72 hours of receipt of standard-of-care (vancomycin or fidaxomicin) antibiotic treatment for R-CDI prior to intervention.

Exclusion Criteria:

Evidence of colon/small bowel perforation at the time of study screening
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.
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
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).
Receipt of FMT or enrollment in a clinical trial for FMT within the last 3 months.

Sites / Locations

Hospital of the Univeristy of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Single dose of PMT

Two doses of PMT

Arm Description

Administered within 24 hours

Outcomes

Primary Outcome Measures

Number of subjects with resolution of symptoms after treatment with one of the PMT suite of products or control.

Clinical outcome will be compared by determining the proportion of subjects with clinical resolution of diarrhea without recurrence in subjects with R-CDI at 8 weeks (56 days) following FMT.

Secondary Outcome Measures

Number of subjects with resolution of symptoms in relation to the amount of drug product administered versus the quantitative culture the drug product.

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5.0

Frequency of solicited adverse events (AEs) as assessed by CTCAE V5.0

Frequency of serious adverse events (SAEs) as assessed by CTCAE V5.0

Frequency of AEs of special interest (AESIs) as assessed by CTCAE V5.0

All-cause mortality at 30-days following last FMT

All-cause mortality at 60-days following last FMT

Colectomy or diverting ileostomy within 30 days after last FMT

Cumulative days of hospitalization from enrollment until 30 days after FMT

Cumulative days in intensive care unit from enrollment until 30 days after last FMT

Bacteremia from enrollment until 30 days after last FMT

Hospital admission within 60 days of discharge from index hospitalization

Full Information

NCT ID

NCT03973697

First Posted

April 17, 2019

Last Updated

June 16, 2022

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT03973697

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Terminated

Why Stopped

Administrative reasons

Study Start Date

January 13, 2020 (Actual)

Primary Completion Date

August 11, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Clostridium Difficile Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized, open label, comparative

Masking

None (Open Label)

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single dose of PMT

Arm Type

Experimental

Arm Title

Two doses of PMT

Arm Type

Experimental

Arm Description

Administered within 24 hours

Intervention Type

Drug

Intervention Name(s)

Penn Microbiome Therapy - 001

Other Intervention Name(s)

PMT-001

Intervention Description

Fecal Microbiota for Transplant, enema product

Intervention Type

Drug

Intervention Name(s)

Penn Microbiome Therapy - 002

Other Intervention Name(s)

PMT-002

Intervention Description

Fecal Microbiota for Transplant, suspension product

Intervention Type

Drug

Intervention Name(s)

Penn Microbiome Therapy - 003

Other Intervention Name(s)

PMT-003

Intervention Description

Fecal Microbiota for Transplant, capsule product

Primary Outcome Measure Information:

Title

Number of subjects with resolution of symptoms after treatment with one of the PMT suite of products or control.

Description

Clinical outcome will be compared by determining the proportion of subjects with clinical resolution of diarrhea without recurrence in subjects with R-CDI at 8 weeks (56 days) following FMT.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Number of subjects with resolution of symptoms in relation to the amount of drug product administered versus the quantitative culture the drug product.

Time Frame

8 weeks

Title

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5.0

Time Frame

180 Days

Title

Frequency of solicited adverse events (AEs) as assessed by CTCAE V5.0

Time Frame

180 Days

Title

Frequency of serious adverse events (SAEs) as assessed by CTCAE V5.0

Time Frame

180 Days

Title

Frequency of AEs of special interest (AESIs) as assessed by CTCAE V5.0

Time Frame

180 Days

Title

All-cause mortality at 30-days following last FMT

Time Frame

30 days

Title

All-cause mortality at 60-days following last FMT

Time Frame

60 days

Title

Colectomy or diverting ileostomy within 30 days after last FMT

Time Frame

30 days

Title

Cumulative days of hospitalization from enrollment until 30 days after FMT

Time Frame

30 days

Title

Cumulative days in intensive care unit from enrollment until 30 days after last FMT

Time Frame

30 Days

Title

Bacteremia from enrollment until 30 days after last FMT

Time Frame

30 days

Title

Hospital admission within 60 days of discharge from index hospitalization

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Stool positive for C. difficile toxin by EIA or toxin gene by NAAT within 60 days of enrollment. At least one additional prior positive stool test for C. difficile within the prior 12 months (EIA or NAAT as above). Age ≥ 18 years. Minimum of 72 hours of receipt of standard-of-care (vancomycin or fidaxomicin) antibiotic treatment for R-CDI prior to intervention. Exclusion Criteria: Evidence of colon/small bowel perforation at the time of study screening 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. 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 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). Receipt of FMT or enrollment in a clinical trial for FMT within the last 3 months.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ebbing Lautenbach, MD, MPH, MSCE

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital of the Univeristy of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

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