- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03970200
Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)
October 27, 2023 updated by: University of Pennsylvania
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
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).
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Hospital of the Univeristy of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: No investigational product
Participants who receive the antibiotics usually prescribed for C diff infection.
|
Standard of care antibiotics
|
Experimental: 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
|
Standard of care antibiotics
Fecal Microbiota for Transplant, suspension product
Other Names:
Fecal Microbiota for Transplant, capsule product
Other Names:
|
Experimental: 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).
|
Standard of care antibiotics
Fecal Microbiota for Transplant, enema product
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products.
Time Frame: 3 Days
|
The outcome will be satisfied when the subject is discharged from the hospital (not to hospice or palliative care) or, while the subject remains hospitalized, when the following criteria are met for 72 hours:
|
3 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause Mortality at 30 Days Following Last Fecal Microbiota Transplantation (FMT)
Time Frame: 30 Days
|
Number of deaths within 30 days of the last FMT
|
30 Days
|
All-cause Mortality at 60-days Following Last FMT
Time Frame: 60 Days
|
Number of deaths within 60 days of the last FMT
|
60 Days
|
Colectomy or Diverting Ileostomy Within 30 Days After Last FMT
Time Frame: 30 Days
|
30 Days
|
|
Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT
Time Frame: 30 Days
|
30 Days
|
|
Cumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT
Time Frame: 30 Days
|
30 Days
|
|
Bacteremia From Enrollment Until 30 Days After Last FMT
Time Frame: 30 Days
|
30 Days
|
|
Repeat Hospital Admission Within 60 Days of Discharge From Index Hospitalization
Time Frame: 60 Days
|
60 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ebbing Lautenbach, MD, MPH, MSCE, Division of Infectious Diseases, Department of Medicine, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 16, 2020
Primary Completion (Actual)
November 21, 2021
Study Completion (Actual)
May 14, 2022
Study Registration Dates
First Submitted
April 17, 2019
First Submitted That Met QC Criteria
May 29, 2019
First Posted (Actual)
May 31, 2019
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 27, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB # 832962
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Severe Clostridium Difficile Infection
-
Vedanta Biosciences, Inc.CompletedClostridium Difficile Infection | Clostridium Difficile Infection Recurrence | Clostridium Difficile | CDI | Clostridioides Difficile Infection | Clostridioides Difficile | Clostridioides Difficile Infection RecurrenceUnited States, Canada
-
Vedanta Biosciences, Inc.Not yet recruitingClostridium Difficile Infection Recurrence | Recurrent Clostridium Difficile Infection | Clostridium Difficile | Diarrhea Infectious | CDI | Clostridium Difficile Infections | Clostridioides Difficile Infection | C.Difficile Diarrhea | Clostridioides Difficile Infection Recurrence | C. Diff Infection
-
Mikrobiomik Healthcare Company S.L.CompletedRecurrent Clostridium Difficile Infection | Primary Clostridium Difficile InfectionSpain
-
University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences Institute; North Carolina...CompletedClostridium DifficileUnited States
-
University Health Network, TorontoTerminatedRecurrent Clostridium Difficile Infection | Laboratory Confirmed Clostridium Difficile InfectionCanada
-
University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)Enrolling by invitationClostridium Difficile Infection | Clostridium Difficile | C Difficile ColitisUnited States
-
Hospital Universitario Evangelico de CuritibaNot yet recruitingClostridium Difficile Infections
-
DeinoveRecruitingClostridium Difficile (C. Difficile)United States, Canada
-
MJM BontenUniversiteit Antwerpen; Universitätsklinikum Köln; Da VolterraCompletedClostridium DifficileGermany, Spain, France, Greece, Netherlands, Romania
-
Astellas Pharma Europe Ltd.Cubist Pharmaceuticals LLCTerminatedClostridium DifficileSpain, France, Germany, Greece, Denmark, Austria, Poland
Clinical Trials on Antibiotics
-
Eastern Virginia Medical SchoolNot yet recruitingPreterm Premature Rupture of Membrane
-
Centre Hospitalier Universitaire, AmiensRecruiting
-
Rush University Medical CenterRothman Institute OrthopaedicsCompletedArthroplasty | InfectionUnited States
-
Atlantic Health SystemRecruitingStress Urinary Incontinence | Postoperative Urinary Tract Infection | Urethral BulkingUnited States
-
Southern Illinois UniversityWashington University School of MedicineCompleted
-
Prisma Health-UpstateTerminated
-
Brigham and Women's HospitalDana-Farber Cancer InstituteNot yet recruitingFebrile Neutropenia | Hematologic Malignancy | Antibiotic Stewardship
-
Washington University School of MedicineSt. Louis UniversityTerminatedThe Primary Outcome of This Study Will be the Rate of EndometritisUnited States
-
Children's Hospital of PhiladelphiaCompletedAcute Otitis Media | Acute Sinusitis | Group A Streptococcal PharyngitisUnited States
-
Lady Hardinge Medical CollegeRecruitingAntibiotic Stewardship | Early-Onset Neonatal SepsisIndia