Severe Acute Respiratory Illness Clinical Trial
Official title:
A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Nitazoxanide Versus Placebo in Addition to Standard Care for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness
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.
Respiratory viral infections are one of the most common causes of illness in the world. These
infections are major causes of SARI and can lead to severe outcomes, including
hospitalization and death. NTZ is a medication that is approved in the United States and
Mexico to treat gastrointestinal parasitic diseases. This study will evaluate the use of NTZ
to treat SARI. The purpose of this study is to evaluate the safety, effectiveness, and
tolerability of NTZ, in combination with standard care, in treating SARI in people who are
hospitalized.
Participants will be hospitalized and study entry assessments will include medical
assessments, blood collection, and a nasopharyngeal swab or wash. Participants will then be
randomly assigned to receive NTZ or placebo for 5 days. Participants younger than 12 years
will receive an oral suspension formulation of NTZ or placebo; participants 12 years and
older will receive NTZ or placebo tablets. All participants will also receive standard of
care treatment for acute severe viral respiratory infections, which may include antibiotics
and/or treatment for influenza. They will be discharged from the hospital based on their
doctors' recommendations. Participants will record their temperature and symptoms in a daily
diary, which will be reviewed by study staff during study visits. Follow-up visits will occur
on Days 3, 7, 14, and 28, and may occur as inpatient or outpatient visits. These visits may
include the same assessments that occurred at baseline, as well as physical examinations,
depending on the visit. Participants who are still hospitalized at Day 28 will be followed by
study staff until they are discharged from the hospital.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01432340 -
Seasonal Influenza Vaccine Effectiveness Study in Kenya
|
N/A |