NCT00304876

Brief Summary

The investigators propose to study intensively the bacteriology of feces in C. difficile associated diarrheal disease, using a variety of conventional and very up-to-date techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

2 active sites

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

October 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

September 10, 2010

Status Verified

September 1, 2010

Enrollment Period

1.3 years

First QC Date

March 16, 2006

Last Update Submit

September 9, 2010

Conditions

EnterocolitisPseudomembranous ColitisAntibiotic-Associated Colitis

Keywords

Clostridium difficile associated diarrhea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients positive for C. difficile

You may qualify if:

  • Patients with antibiotic-associated diarrhea with a positive assay for C. difficile toxin
  • Patients with antibiotic-associated diarrhea with 3 negative assays for C. difficile toxin
  • Patients with antibiotic-associated diarrhea that has failed to respond to conventional therapy
  • Hospitalized patients who have received \>2 antibiotics and who have no symptoms of diarrhea or abdominal discomfort

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Medical Research Institute

Baltimore, Maryland, 21205, United States

Location

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

EnterocolitisEnterocolitis, Pseudomembranous

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesClostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Daniel M Musher, M.D.

    Baylor College of Medicine, Houston VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 20, 2006

Study Start

October 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

September 10, 2010

Record last verified: 2010-09

Locations

US(2)