Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Romark Laboratories L.C.
• Treatments: Nitazoxanide

Criteria

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