Conditions: Influenza
Keywords: influenza
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 624
Healthy volunteers: no

Brief summary:
This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated influenza in adults and adolescents. The investigators hypothesize that treatment with Nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza infection. Secondarily, the investigators 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.

Detailed description:
A Randomized, Double-Blind, Placebo Controlled Study of Nitazoxanide in Adults and Adolescents with Acute Uncomplicated Influenza. The primary objectives of this study are to demonstrate the efficacy of nitazoxanide administered 300 mg two times per day for 5 days or 600 mg two times per day for 5 days in reducing the time to resolution of all clinical symptoms of influenza.

The study will also evaluate pharmacokinetics of nitazoxanide in a subset of 24 patients and the safety of the nitazoxanide regimen compared to a placebo via analysis of adverse events and laboratory safety tests.

Blood samples will be collected for all patients at baseline, day 7 and day 28, and for a subset of 24 patients aged 18-65 years (pharmacokinetics subset) on day 2. Urine samples will be collected at baseline and day 7. Nasal swabs will be collected at baseline and day 7 for all patients and on days 2, 3, 4 and 5 for a subset of patients (approximately 20% of patients).

Arms:
arm 1: 300 mg nitazoxanide tablet and 1 placebo tablet twice daily for 5 days arm 2: Two 300 mg nitazoxanide tablets(600mg) twice daily for 5 days arm 3: 2 placebo tablets twice daily for 5 days

Interventions: intervention 1: Nitazoxanide intervention 2: Nitazoxanide intervention 3: Placebo
Intervention descriptions: intervention 1: Tablets, 300 mg (one 300 mg tablet + 1 placebo tablet) with food twice daily for 5 days intervention 2: Tablets, 600 mg (two 300 mg tablets) with food twice daily for 5 days intervention 3: Tablets, (2 tablets) twice daily with food for 5 days

Protocol document: