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NCT Number: NCT01328925

Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.

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Key information

Conditions

Rotavirus Infection Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Viral Gastroenteritis Due to Rotavirus Virus Diseases

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cairo University Children's Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age < 6 years.
  • Patients with diarrhea (defined as 3 or more liquid stools per day).
  • Stool positive for rotavirus by ELISA.

Exclusion criteria

  • Other identified causes of diarrhea at screening (pathogenic protozoa, bacteria, viruses or lactose intolerance).
  • Serious systemic disorders incompatible with the study.

Treatment and study plan

Nitazoxanide

Drug

Nitazoxanide Oral Suspension dose based on age:

Age <12 months- 7.5 mg/kg by mouth twice daily for 3 days; Age 12-47 months- 100 mg/5 ml by mouth twice daily for 3 days; Age 48-72 months- 200 mg/10 ml by mouth twice daily for 3 days

Other names: Alinia, NTZ

Primary outcomes

  1. Time from first dose to resolution of symptoms.

    Time frame: Up to 14 days

    Resolution of all gastrointestinal symptoms associated with viral diarrhea at enrollment including abdominal pain or tenderness, distention, etc. with the patient not requiring anti-motility or other palliative treatment. Symptom resolution must be maintained for at least 48 hours to be considered valid.

Secondary outcomes

  1. Time from first dose to virologic response

    Time frame: Up to 14 days

    Daily stool samples will be analyzed by ELISA for the presence of rotavirus. Virologic response is defined by a negative ELISA stool test for rotavirus on 2 consecutive days.

  2. Time from first dose to hospital discharge

    Time frame: Up to 14 days

    For hospitalized patients, the study will monitor the time in hours from the first dose of study medication to discharge from the hospital.

  3. Volume of oral rehydration solutions consumed

    Time frame: Up to 14 days

  4. Frequency of intravenous rehydration required

    Time frame: Up to 14 days

  5. Stool weight

    Time frame: Up to 14 days

Sponsors and collaborators

Lead sponsor

Romark Laboratories L.C.

Industry

Registry information

Official study title

Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 5, 2011
Registry last updated
Apr 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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