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Trial record 7 of 24 for:    "Enterocolitis" | "Anti-Infective Agents"

Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00304356
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Daniel M. Musher MD, VA Medical Center, Houston

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Clostridium Enterocolitis
Pseudomembranous Colitis
Intervention Drug: Nitazoxanide
Enrollment 22
Recruitment Details Chart review at the Houston VA for patients treated with Nitazoxanide who have failed previous therapy.
Pre-assignment Details This is a retrospective chart review.
Arm/Group Title Nitazoxanide
Hide Arm/Group Description [Not Specified]
Period Title: Nitazoxanide
Started 27
Completed 22
Not Completed 5
Reason Not Completed
Physician Decision             5
Period Title: Nitazoxanide
Started 27
Completed 22
Not Completed 5
Reason Not Completed
Physician Decision             1
number is 0             1
Physician Decision             1
Physician Decision             1
Physician Decision             1
Arm/Group Title Nitazoxanide
Hide Arm/Group Description Patients with C. difficle who exhibit diarrhea and received nitazoxanide.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
27  (27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
0
   0.0%
Male
27
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title Nitazoxanide
Hide Description stopping of diarrhea
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nitazoxanide
Hide Arm/Group Description:
time diarrhea from C. difficile stopped.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
27
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nitazoxanide
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Nitazoxanide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nitazoxanide
Affected / at Risk (%)
Total   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nitazoxanide
Affected / at Risk (%)
Total   0/27 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniel Musher
Organization: VA Houston
Phone: 713-794-7386
EMail: daniel.musher@va.gov
Layout table for additonal information
Responsible Party: Daniel M. Musher MD, VA Medical Center, Houston
ClinicalTrials.gov Identifier: NCT00304356     History of Changes
Other Study ID Numbers: H-15601
First Submitted: March 16, 2006
First Posted: March 17, 2006
Results First Submitted: February 19, 2013
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017