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

Participant milestones
Measure
Nitazoxanide
Nitazoxanide
STARTED
27
Nitazoxanide
COMPLETED
22
Nitazoxanide
NOT COMPLETED
5

Reasons for withdrawal

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

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 days

stopping of diarrhea

Outcome measures

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

Daniel Musher

VA Houston

Phone: 713-794-7386

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place