Trial Outcomes & Findings for Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection (NCT NCT00304356)
NCT ID: NCT00304356
Last Updated: 2017-12-15
Results Overview
stopping of diarrhea
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
22 participants
Primary outcome timeframe
30 days
Results posted on
2017-12-15
Participant Flow
Chart review at the Houston VA for patients treated with Nitazoxanide who have failed previous therapy.
This is a retrospective chart review.
Participant milestones
| Measure |
Nitazoxanide
|
|---|---|
|
Nitazoxanide
STARTED
|
27
|
|
Nitazoxanide
COMPLETED
|
22
|
|
Nitazoxanide
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Nitazoxanide
|
|---|---|
|
Nitazoxanide
Physician Decision
|
1
|
|
Nitazoxanide
number is 0
|
1
|
Baseline Characteristics
Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection
Baseline characteristics by cohort
| Measure |
Nitazoxanide
n=27 Participants
Patients with C. difficle who exhibit diarrhea and received nitazoxanide.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysstopping of diarrhea
Outcome measures
| Measure |
Nitazoxanide
n=27 Participants
time diarrhea from C. difficile stopped.
|
|---|---|
|
Nitazoxanide
|
27 participants
|
Adverse Events
Nitazoxanide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place