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Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH) (MATCH)

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ClinicalTrials.gov Identifier: NCT03005379
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: Fecal Microbiota Therapy (FMT) Drug: Placebo Phase 2 Phase 3

Detailed Description:

Clostridium difficile infection (CDI) is one of the most common nosocomial infections and is increasingly seen in non-hospitalized patients. Although more than 90% of patients have symptom resolution with a course of standard antimicrobial therapy, subsequent recurrence rates range from 15-30% (after the first CDI episode) to 40-50% (after the second and subsequent episodes). Fecal microbiota transplantation (FMT) has shown promise as an adjunct to standard antimicrobial therapy, reducing recurrence among FMT recipients to 15%.

The primary study goal is to assess the efficacy of FMT for the prevention of subsequent recurrent CDI, when administered after successful treatment of recurrent CDI with standard antimicrobial therapy. Secondary goals are to evaluate, the efficacy of FMT in terms of CDI severity, duration, the safety of FMT, and in the event of a positive study result, establish a mechanism for providing FMT within the VA system.

This study will enroll 390 participants. Participants will be randomized (1:1 ratio) to FMT or placebo, stratified by number of prior recurrent CDI episodes (1 versus >1). They will be assessed for symptoms of CDI, other study outcomes and any treatment-related adverse events at 2, 14, 28, 42, and 56 days, and month 3, 4, 5 and 6 after administration of the study treatment.

The primary outcome is recurrent CDI (definite or possible) or death within 56 days of randomization.

Definite recurrence is defined as any of the following: The new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis; Other clinical symptoms including ileus, toxic megacolon, or colectomy; PLUS Laboratory confirmation of C. difficile from a stool specimen by EIA toxin test. Possible recurrence is defined as the same clinical manifestations as above, but WITHOUT laboratory confirmation of C. difficile (stool test not sent, negative EIA toxin test result, or uninterpretable result).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: CSP #2004 - Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Active Comparator: 1
Fecal Microbiota Therapy (FMT)
Drug: Fecal Microbiota Therapy (FMT)
Oral capsule-delivered FMT

Placebo Comparator: 2
Placebo
Drug: Placebo
Oral capsule-delivered placebo




Primary Outcome Measures :
  1. Recurrent CDI (definite or probable) or death [ Time Frame: Within 56 days of randomization ]

    The primary outcome is recurrent CDI (definite or probable) or death within 56 days of randomization.

    Definite recurrence is defined as any of the following:

    • The new onset of more than three loose or watery stools in 24 hours for two consecutive days
    • Other clinical symptoms including ileus, toxic mega colon, or colectomy PLUS
    • Laboratory confirmation of C. difficile from a stool specimen.

    Probable recurrence is defined as the same clinical manifestations as above, but WITHOUT laboratory confirmation of C. difficile (stool test not sent, negative result, or uninterpretable result).



Secondary Outcome Measures :
  1. Recurrent CDI (definite or possible), or death [ Time Frame: Within 6 months of randomization ]
    The incidence of recurrent CDI (definite or possible) or death within 6 months of randomization.

  2. Quality of Life [ Time Frame: 56 days from randomization ]
    The investigators will use a brief assessment of both overall and gastrointestinal health status, using a previously validated instrument.

  3. Number of CDI recurrences [ Time Frame: Within 6 months of randomization ]
    The number of CDI recurrences within 6 months for a patient is the count of separate CDI recurrences from randomization to 6 months after randomization.

  4. Diarrhea that is negative for C. difficile by EIA toxin test and PCR [ Time Frame: Within 56 days of randomization ]
    This is similar to probable recurrent CDI, but includes only episodes of diarrhea that test negative for C. difficile by EIA toxin test and PCR, not episodes that are not tested or are uninterpretable.

  5. Multiple related symptoms [ Time Frame: Within 6 months of randomization ]
    An assessment for non-diarrheal manifestations of CDI such as abdominal pain, urgency, and fecal incontinence will be performed.

  6. Definite recurrent CDI [ Time Frame: Within 56 days of randomization ]

    The incidence of definite recurrent CDI within 56 days of randomization. Definite recurrence is defined as any of the following:

    • The new onset of more than three loose or watery stools in 24 hours for two consecutive days
    • Other clinical symptoms including ileus, toxic mega colon, or colectomy PLUS
    • Laboratory confirmation of C. difficile from a stool specimen.

  7. Possible recurrent CDI [ Time Frame: Within 56 days of randomization ]
    The incidence of probable recurrent CDI within 56 days of randomization. Possible recurrence is defined as the same clinical manifestations as definite recurrent CDI, but WITHOUT laboratory confirmation of C. difficile (stool test not sent, negative result, or uninterpretable result).

  8. Death [ Time Frame: Within 56 days of randomization ]
    The incidence of death within 56 days of randomization.

  9. Diarrhea that is negative for C. difficile by EIA toxin testing but positive by PCR [ Time Frame: Within 56 days of randomization ]
    This is similar to possible recurrent CDI, but includes only episodes of diarrhea that test negative for C. difficile by EIA toxin test, not episodes that are not tested or are uninterpretable.


Other Outcome Measures:
  1. Adverse and Serious Adverse Events [ Time Frame: Within 6 months of randomization ]

    Safety outcomes to be collected include:

    • Serious adverse events, with a focus on SAEs involving hospitalization (new or prolonged), and all-cause mortality
    • Adverse events which may be related to FMT treatment. This includes adverse events which Site Investigators consider related/possibly related to the study treatment and all adverse events which occur within 14 days of study treatment (since an aggregate analysis of events temporally linked to treatment could show a causal relationship when compared to placebo)
    • Infectious transmissions which are plausibly linked to FMT treatment.
    • Development of new conditions theoretically linked to alterations in gut microbiota.



Information from the National Library of Medicine

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 recurrent CDI (defined as > 3 loose/watery stools/24h for 2 consecutive days with CDI treatment, and not explained by another diagnosis PLUS laboratory confirmation of C. difficile; or ileus, or toxic megacolon PLUS laboratory confirmation of C. difficile, occurring within 90 days of a prior CDI episode with similar symptoms and laboratory confirmation)
  2. Resolution or improvement of symptoms from most recent CDI episode, defined as no longer meeting the clinical definition for CDI for a 48 hour period during treatment, including not meeting the definition again after an initial improvement
  3. Within the enrollment window: 2 days after completion of antimicrobial therapy for CDI (to allow for a washout period) to 14 days after completion of therapy or 30 days after the onset of CDI whichever is later.
  4. Age 18 years
  5. Enrolled in a VHA facility
  6. Able and willing to provide informed consent

Exclusion Criteria:

  1. Unlikely to swallow capsules
  2. Pregnancy, planning to be pregnant, or breastfeeding
  3. Receipt of cytotoxic chemotherapy, intravenous or subcutaneous immune globulin, or confirmed neutropenia (absolute neutrophil count of < 1,000 cells/ L) within the past 3 months
  4. Inflammatory bowel disease or other chronic diarrheal disease/fecal incontinence predating CDI
  5. Ongoing antibiotic use other than those for the current episode of CDI
  6. Prior FMT
  7. Life expectancy of < 8 weeks
  8. Anaphylactic food allergy
  9. Active enrollment in another research study on antibiotics, probiotics, or FMT without investigators approval
  10. Presence of an ileostomy or colostomy
  11. HIV with CD4 count < 200 cells/�L in prior 3 months
  12. Decompensated cirrhosis
  13. Bone marrow/peripheral blood stem cell transplant in the past year
  14. Unlikely to follow study protocol

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): NCT03005379


Contacts
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Contact: Jane Zhang, PhD (203) 932-5711 ext 3779 jane.zhang@va.gov
Contact: Tassos Kyriakides (203) 932-5711 ext 3771 tassos.kyriakides@va.gov

Locations
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United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Dimitri M Drekonja, MD    612-725-2000 ext 4183    Dimitri.Drekonja@va.gov   
Contact: Ruth Anway, RN    (612) 467-2860    ruth.anway@va.gov   
Study Chair: Aasma Shaukat, MD MPH         
Study Chair: Dimitri M Drekonja, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Study Chair: Dimitri M Drekonja, MD Minneapolis VA Health Care System, Minneapolis, MN
Study Chair: Aasma Shaukat, MD MPH Minneapolis VA Health Care System, Minneapolis, MN

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03005379     History of Changes
Other Study ID Numbers: 2004
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Digital data underlying primary scientific publications from this study will be held as part of a data sharing resource maintained by the Cooperative Studies Program (CSP). Study data held for this purpose may include data, data content, format, and organization. The data may be available to the public and other VA and non-VA researchers under certain conditions and consistent with the informed consent and CSP policy which prioritize protecting subjects' privacy and confidentiality to the fullest extent possible.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
FMT
recurrent c. difficile
infectious disease
intestine
clinical trial
gastrointestinal
prevention
randomized
diarrhea
fecal microbiota therapy

Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents