NCT00302640

Brief Summary

The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_2

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

February 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2006

Completed
Last Updated

May 31, 2012

Status Verified

May 1, 2012

First QC Date

March 13, 2006

Last Update Submit

May 30, 2012

Conditions

Rotavirus InfectionAdenoviridae InfectionNorovirus Infection

Outcome Measures

Primary Outcomes (1)

  • Time from first dose to resolution of symptoms.

    Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group

    P-0.0105

Secondary Outcomes (1)

  • Virologic response (negative ELISA) at day 7-10.

Study Arms (2)

Nitazoxanide

ACTIVE COMPARATOR

7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days

Drug: Alinia (nitazoxanide)

Placebo

PLACEBO COMPARATOR

7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days

Drug: Alinia (nitazoxanide)

Interventions

Alinia (nitazoxanide)DRUG
NitazoxanidePlacebo

Eligibility Criteria

AgeUp to 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age \<12 years.
  • Patients with diarrhea (defined as 3 or more stools per day with liquid or semi-solid consistency, the number and consistency of stools being unusual for that person).
  • Stool positive for adenovirus, norovirus or rotavirus by ELISA.

You may not qualify if:

  • Females who are pregnant, suspected of being pregnant or breastfeeding.
  • Other identified causes of diarrhea at screening.
  • Serious systemic disorders incompatible with the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rossignol JF, Abu-Zekry M, Hussein A, Santoro MG. Effect of nitazoxanide for treatment of severe rotavirus diarrhoea: randomised double-blind placebo-controlled trial. Lancet. 2006 Jul 8;368(9530):124-9. doi: 10.1016/S0140-6736(06)68852-1.

    PMID: 16829296RESULT

MeSH Terms

Conditions

Rotavirus InfectionsAdenoviridae InfectionsCaliciviridae Infections

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsDNA Virus Infections

Study Officials

  • Mona Abu-Zekry, MD

    Cairo University Children's Hospital, Cairo, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 14, 2006

Study Start

February 1, 2005

Study Completion

September 1, 2005

Last Updated

May 31, 2012

Record last verified: 2012-05