Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza
| Status: | Terminated |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | January 2010 |
| End Date: | December 2010 |
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza
This is a randomized clinical trial designed to evaluate oral nitazoxanide compared to a
placebo in the treatment of acute uncomplicated influenza in adults. We hypothesize that
treatment with nitazoxanide will reduce the duration of symptoms in patients with confirmed
influenza infection. Secondarily, we hypothesize that treatment with nitazoxanide will reduce
the complications of influenza, severity of symptoms, time lost from work, time to return to
normal daily activities, and viral shedding.
placebo in the treatment of acute uncomplicated influenza in adults. We hypothesize that
treatment with nitazoxanide will reduce the duration of symptoms in patients with confirmed
influenza infection. Secondarily, we hypothesize that treatment with nitazoxanide will reduce
the complications of influenza, severity of symptoms, time lost from work, time to return to
normal daily activities, and viral shedding.
The study is conducted at approximately 25 sites in the United States. Subjects selected
based on symptoms will be randomized to receive oral nitazoxanide or placebo twice daily for
5 days. Subjects will be monitored by daily by telephone or home visit to monitor symptoms
and complications of influenza for safety and will be referred for medical care as required.
Subjects will complete a diary twice daily to record the presence and severity of symptoms,
ability to perform normal daily activities and time lost from work. Complications of
influenza (including sinusitis, otitis, bronchitis, pneumonia, central nervous system
disease) and other adverse events will be reported. Nasopharyngeal swabs will be collected at
Baseline (Day 0) and Day 7 for all patients and on Days 1 through 4 for a subset of patients
to test for influenza A (including novel H1N1), influenza B and 17 other respiratory viruses
by RT-PCR and culture and to evaluate quantitative viral shedding. The primary analysis will
be for patients with confirmed influenza, and secondary analyses will be conducted for
subjects with any respiratory virus and for all treated subjects.
based on symptoms will be randomized to receive oral nitazoxanide or placebo twice daily for
5 days. Subjects will be monitored by daily by telephone or home visit to monitor symptoms
and complications of influenza for safety and will be referred for medical care as required.
Subjects will complete a diary twice daily to record the presence and severity of symptoms,
ability to perform normal daily activities and time lost from work. Complications of
influenza (including sinusitis, otitis, bronchitis, pneumonia, central nervous system
disease) and other adverse events will be reported. Nasopharyngeal swabs will be collected at
Baseline (Day 0) and Day 7 for all patients and on Days 1 through 4 for a subset of patients
to test for influenza A (including novel H1N1), influenza B and 17 other respiratory viruses
by RT-PCR and culture and to evaluate quantitative viral shedding. The primary analysis will
be for patients with confirmed influenza, and secondary analyses will be conducted for
subjects with any respiratory virus and for all treated subjects.
Inclusion Criteria:
- Age 18 to 65 years
- Fever, respiratory symptoms and constitutional symptoms compatible with influenza
infection
- Influenza A or B infection in the local community
- Onset of illness no more than 48 hours before presentation
- Willing and able to provide comply with protocol requirements
Exclusion Criteria:
- Severity of illness requiring or anticipated to require in-hospital care
- High risk of complications from influenza per IDSA (Infectious Diseases Society of
America) guidelines or current CDC (Centers for Disease Control) criteria
- Females pregnant, breast-feeding or sexually active without birth control
- Vaccination for seasonal influenza or H1N1 on or after August 1, 2009
- Treatment with antiviral medication for influenza within 1 month prior to screening
- Treatment with nitazoxanide or any investigational drug within 1 month prior to
screening
- Known sensitivity to nitazoxanide or any excipients
- Unable to take oral medications
- Chronic kidney or liver disease or known impaired hepatic and/or renal function
- Other pre-existing chronic infection undergoing or requiring medical therapy
- Pre-existing illness placing subject at unreasonably increased risk by participation
in study
- Unlikely to comply with the requirements of this protocol
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