NCT00304369

Brief Summary

In this record review study, our objective is to determine the rates of cure, failure and relapse following treatment of C. difficile colitis with metronidazole.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

March 16, 2006

Last Update Submit

February 14, 2013

Conditions

Clostridium EnterocolitisPseudomembranous ColitisAntibiotic-Associated Colitis

Keywords

Clostridium difficile

Interventions

MetronidazoleDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • records of patients who have a fecal sample positive for C. difficile toxin and who are then treated for C. difficile colitis with oral metronidazole will be included in this study.

You may not qualify if:

  • Patients who did not receive at least 7 days of metronidazole

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

Enterocolitis, Pseudomembranous

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Daniel M Musher, M.D.

    Michael E. DeBakey VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 17, 2006

Study Start

June 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

US(1)