Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

Romark Laboratories

Status and phase

Terminated

Phase 2

Conditions

Influenza

Treatments

Drug: Placebo

Drug: Nitazoxanide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01056380

RM01-2027

Details and patient eligibility

About

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.

Full description

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.

Enrollment

79 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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