NCT00683982

Brief Summary

Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be clinically important in time of hospitalization and reduction of duration of diarrhea secondary to rotavirus?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

August 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
Last Updated

May 26, 2008

Status Verified

May 1, 2008

Enrollment Period

9 months

First QC Date

May 22, 2008

Last Update Submit

May 23, 2008

Conditions

DiarrheaRotavirus Infection

Keywords

nitazoxanideProbioticsDiarrheaRotavirusChildren

Outcome Measures

Primary Outcomes (1)

  • Duration of diarrhea

    Hours

Secondary Outcomes (1)

  • Duration of hospitalization

    hours

Study Arms (3)

1

ACTIVE COMPARATOR

This group will receive oral nitazoxanide preparation

Drug: Nitazoxanide

2

ACTIVE COMPARATOR

This group will receive a mix combination of probiotics

Drug: Probiotic mix preparation

3

PLACEBO COMPARATOR

This is the control group receiving only oral or systemic hydration solutions

Other: Oral hydration solutions

Interventions

NitazoxanideDRUG

Nitazoxanide 15mg/Kg/day twice day for 3 days

Also known as: Noxom; Givotan
1
Probiotic mix preparationDRUG

Probiotic preparation 1 gram twice a day for 5 days

Also known as: Probiotic
2
Oral hydration solutionsOTHER

Oral hydration solutions as needed

Also known as: Rehsal 60, 2.5% Glucosaline
3

Eligibility Criteria

Age28 Days - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Positive stool sample for rotavirus test

You may not qualify if:

  • Severe malnourishment
  • Severe dehydration
  • History of diarrhea more than 3 days previous hospitalization
  • Use of antibiotics, probiotics or nitazoxanide 3 weeks before admission
  • Systemic infections
  • Severe chronic disease
  • Mixed enteric infections besides rotavirus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Pediatrico Albina Patiño

Cochabamba, Departamento de Cochabamba, 591, Bolivia

Location

MeSH Terms

Conditions

DiarrheaRotavirus Infections

Interventions

nitazoxanideProbiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsReoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Carlos N Teran, M.D

    Centro Pediatrico Albina Patiño

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 26, 2008

Study Start

August 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 26, 2008

Record last verified: 2008-05

Locations

BO(1)