Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

NCT ID: NCT01056380

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-12-31

Brief 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.

Detailed 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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nitazoxanide

Group Type: ACTIVE_COMPARATOR

Nitazoxanide

Intervention Type: DRUG

Tablet, 500 mg with food twice daily for 5 days

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablet, twice daily with food for 5 days

Interventions

Nitazoxanide

Tablet, 500 mg with food twice daily for 5 days

Intervention Type: DRUG

Placebo

Tablet, twice daily with food for 5 days

Intervention Type: DRUG

Other Intervention Names

Alinia, NTZ; Sugar pill

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Romark Laboratories L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-François Rossignol, MD, PhD

Role: STUDY_CHAIR

The Romark Institute for Medical Research

Locations

Health Sciences Research Center at Asthma and Allergy Associates, P.C.

Elmira, New York, United States

Countries

United States

Other Identifiers

RM01-2027

Identifier Type: -

Identifier Source: org_study_id