NCT02355938

Brief Summary

The primary purpose of this study is to compare the clinical outcomes of cure and recurrence of Clostridium difficile infection in spinal cord injured patients who are treated with oral Fidaxomicin vs. oral Vancomycin. The secondary aim of this study is to compare the overall costs of treatment of Clostridium difficile infection in the two study groups.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

2.7 years

First QC Date

January 30, 2015

Last Update Submit

October 12, 2016

Conditions

Clostridium DifficileSpinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Cure of Clostridium Difficile

    Decrease in number and frequency of loose stools

    10 Days

Secondary Outcomes (1)

  • Cost Benefit Analysis

    Hospitalization cost 6 months before and 6 months after treatment

Study Arms (2)

Fidaxomicin Arm

EXPERIMENTAL

Oral Fidaxomicin 200 mg every 12 hours (Placebo for 2 doses) for 10 days

Drug: Fidaxomicin 200 mgDrug: Placebo

Vancomycin Arm

ACTIVE COMPARATOR

Oral Vancomycin 125 mg every 6 hours for 10 days

Drug: Vancomycin

Interventions

Fidaxomicin 200 mgDRUG

Fidaxomicin 200 mg every 12 hours

Also known as: Dificid
Fidaxomicin Arm
PlaceboDRUG

1 dose of placebo every 6 hours x 2 doses

Also known as: Cellulose Capsule
Fidaxomicin Arm
VancomycinDRUG

Vancomycin 125 mg every 6 hours

Also known as: Vancocin
Vancomycin Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability of subject to provide an informed consent
  • Legally Authorized Representative-Adult must provide consent in case the subject is unable to consent
  • Diagnosis of Clostridium difficile disease based on clinical manifestations (change in bowel habits, at least 2 more unformed bowel movements as compared to baseline neurogenic bowel function in the same patient in the 24-hour period prior to randomization)
  • Lab data (positive polymerase chain reaction test for Clostridium difficile in a stool specimen obtained within 72 hours before randomization)
  • Patient has not received antibiotics that are active against Clostridium difficile for any more than 24 hours prior to being screened for this study.

You may not qualify if:

  • Receipt of agents (oral Vancomycin, oral or IV Metronidazole, oral rifamdin, oral bacitracin, or oral fusidic acid) that are active against Clostridium difficile for longer than 24 hours after randomization
  • Life-threatening or fulminant Clostridium difficile infection, presence of toxic megacolon, and history of inflammatory bowel disease (Crohn's disease and ulcerative colitis)
  • Allergy to study medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

FidaxomicinCelluloseVancomycin

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsPolyketidesMacrocyclic CompoundsPolycyclic CompoundsGlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureGlycopeptidesGlycoconjugatesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Rabih O Darouiche, MD

    Michael E. DeBakey VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 4, 2015

Study Start

February 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Enrollment to low for statistical analysis.

Locations

US(1)