NCT00304408

Brief Summary

The purpose of this study is three fold: 1)To collect serum from patients with documented Clostridium difficile infection and test for the presence of antibody to C. difficile toxin at the start and at the end of therapy, and again if a relapse or recurrence occurs. 2)To collect stool samples for test of C. difficile toxin at similar time intervals. 3)To assay random serum samples from the VA lab in order to determine the rate of antibody to C. difficile toxin in our patient population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2005

Typical duration for all trials

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

January 1, 2005

Completed
1.2 years 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
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

September 10, 2010

Status Verified

September 1, 2010

Enrollment Period

3 years

First QC Date

March 16, 2006

Last Update Submit

September 9, 2010

Conditions

Clostridium EnterocolitisPseudomembranous ColitisAntibiotic-Associated Colitis

Keywords

Clostridium difficile

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients positive for C. difficile.

You may qualify if:

  • All patients at the Houston VA with documented C. difficile infection

You may not qualify if:

  • None

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

Condition Hierarchy (Ancestors)

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

Study Officials

  • Daniel M Musher, M.D.

    Michael E. DeBakey VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 17, 2006

Study Start

January 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

September 10, 2010

Record last verified: 2010-09

Locations

US(1)