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Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness

NCT02057757 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2018-08-01

Study results available
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Summary

Respiratory viruses are a significant cause of hospitalization for respiratory tract infections. This study will evaluate the safety, effectiveness, and tolerability of nitazoxanide (NTZ) in treating severe acute respiratory illness (SARI) in people who are hospitalized.

Conditions

  • Severe Acute Respiratory Illness

Interventions

DRUG

Nitazoxanide

Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.

DRUG

Placebo

Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Sponsors & Collaborators

  • Mexican Emerging Infectious Diseases Clinical Research Network

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Lourdes Guerrero Almeida, M.D. · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  • Ana Gamiño, M.D. · Hospital Infantil de Mexico Federico Gomez

  • Arturo Galindo Fraga, M.D. · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  • Sarbelio Moreno, M.D. · Hospital Infantil de Mexico Federico Gomez

  • Javier Araujo Melendez, M.D. · Hospital Central "Dr. Ignacio Morones Prieto"

  • Alejandra Ramirez Venegas, M.D. · Instituto Nacional de Enfermedades Respiratorias

  • Beatriz Llamosas Gallardo, M.D. · Instituto Nacional de Pediatria

  • Yuri Roldan Aragon, M.D. · Hospital General Dr. Aurelio Valdivies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-05-31
Completion
2018-01-31

Countries

  • Mexico

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02057757 on ClinicalTrials.gov