- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03107169
Treatment of Initial Clostridium Difficile Infection
April 15, 2017 updated by: Adrián Camacho-Ortiz, Universidad Autonoma de Nuevo Leon
Fecal Microbiota Transplant Versus Vancomycin for Treatment of Initial Clostridium Difficile Infection
Investigators designed an open, two-arm study to compare oral vancomycin with a fecal microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Investigators designed an open, two-arm study to compare oral vancomycin with an FMT-FURM as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients.
From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment.
Specimens are cultured to isolate C. difficile, and C. difficile are assessed for the presence of genes encoding enterotoxin (tcdB), cytotoxin (tcdA), the binary toxin A (cdtA), binary toxin B (cdtB), and deletions within the negative regulator of toxin A and B production (tcdC) by polymerase chain reaction (PCR).
The minimum inhibitory concentrations (MICs) of ciprofloxacin, moxifloxacin, erythromycin, clindamycin, vancomycin, metronidazole, linezolid, fidaxomicin, and tetracycline against C. difficile are measured using the agar dilution method.
Fecal samples and FMT-FURM are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
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
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of CDI (first episode)
- Older than 18 years old
Exclusion Criteria:
- Patients younger than 18 years old
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Vancomycin
Patients in this arm received vancomycin 250mg every 6 hrs for 10-14 days
|
Patients in the vancomycin group received oral vancomycin (250 mg every 6 h for 10-14 days)
Other Names:
|
Experimental: FMT-FURM
Patients in this arm receive FMT-FURM
|
Patients in the FMT group received FMT-FURM
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in number of evacuations
Time Frame: up to a 2 days
|
The cure of CDI was measured
|
up to a 2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 1, 2015
Primary Completion (Actual)
September 30, 2015
Study Completion (Actual)
September 30, 2015
Study Registration Dates
First Submitted
March 21, 2017
First Submitted That Met QC Criteria
April 10, 2017
First Posted (Actual)
April 11, 2017
Study Record Updates
Last Update Posted (Actual)
April 18, 2017
Last Update Submitted That Met QC Criteria
April 15, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IF14-005
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
No
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 Clostridium Difficile Infection
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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
-
University of PennsylvaniaTerminatedSevere Clostridium Difficile Infection | Severe-Complicated/Fulminant Clostridium Difficile InfectionUnited States
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Mikrobiomik Healthcare Company S.L.CompletedRecurrent Clostridium Difficile Infection | Primary Clostridium Difficile InfectionSpain
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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
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University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences Institute; North Carolina...CompletedClostridium DifficileUnited States
-
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
-
Chinese University of Hong KongUnknownClostridium Difficile Infection | Clostridium DifficileHong Kong
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