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PMT for Severe-CDI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03970200
Recruitment Status : Terminated (Administrative reasons.)
First Posted : May 31, 2019
Last Update Posted : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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).

Condition or disease Intervention/treatment Phase
Severe Clostridium Difficile Infection Severe-Complicated/Fulminant Clostridium Difficile Infection Drug: Penn Microbiome Therapy - 001 Drug: Penn Microbiome Therapy - 002 Drug: Penn Microbiome Therapy - 003 Drug: Antibiotics Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, open label, comparative
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 16, 2020
Actual Primary Completion Date : November 21, 2021
Actual Study Completion Date : May 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: No investigational product
Participants who receive the antibiotics usually prescribed for C diff infection.
 Drug: Antibiotics
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
 Drug: Penn Microbiome Therapy - 002
Fecal Microbiota for Transplant, suspension product
Other Name: PMT-002

Drug: Penn Microbiome Therapy - 003
Fecal Microbiota for Transplant, capsule product
Other Name: PMT-003

Drug: Antibiotics
Standard of care antibiotics
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).
 Drug: Penn Microbiome Therapy - 001
Fecal Microbiota for Transplant, enema product
Other Name: PMT-001

Drug: Antibiotics
Standard of care antibiotics


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with resolution of symptoms after treatment with one of the PMT suite of products. [ Time Frame: 7 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:

    • If radiology study or studies performed, ileus/dilation/megacolon either not noted or noted as resolved
    • Ileus/megacolon either noted as resolved by any provider documentation or not noted
    • WBC<15,000 cells/uL
    • Serum creatinine decreased, unchanged, or increased by ≤0.2 mg/dL over 72 hours (if not receiving continuous renal replacement therapy (CRRT) or hemodialysis (HD))
    • Lactate ≤2.2 mmol/L (if measured by clinical care team)
    • No vasopressors used (including epinephrine, norepinephrine, phenylephrine, or vasopressin)
    • Temperature <38.5 °C and ≥35.6°C
    • < 8 bowel movements per day and < 600 mL unformed stool (if volume recorded)
    • Meeting fewer than 3 systemic inflammatory response syndrome (SIRS) criteria


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
    • All-cause mortality at 30- and 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
    • Repeat hospital admission within 60 days of discharge from index hospitalization

  2. Frequency solicited adverse events (AEs) as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
  3. Frequency serious adverse events (SAEs) as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
  4. Frequency of AEs of special interest (AESIs) as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]

Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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/F-CDI per current 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. 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. 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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970200


Locations
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United States, Pennsylvania
Hospital of the Univeristy of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Ebbing Lautenbach, MD, MPH, MSCE Division of Infectious Diseases, Department of Medicine, University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03970200    
Other Study ID Numbers: IRB # 832962
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Clostridium Infections
Disease Attributes
Pathologic Processes
 Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Anti-Bacterial Agents
Anti-Infective Agents