Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

Influenza Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01056380
• Other study ID #: RM01-2027
• Status: Terminated
• Phase: Phase 2
• First received: January 23, 2010
• Last updated: April 3, 2018
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2018
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Nitazoxanide
Tablet, 500 mg with food twice daily for 5 days
• Placebo
Tablet, twice daily with food for 5 days

Locations

Country	Name	City	State
United States	Health Sciences Research Center at Asthma and Allergy Associates, P.C.	Elmira	New York

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection)		Up to 28 days
Secondary	Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus)		Up to 28 days
Secondary	Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects)		Up to 28 days
Secondary	Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza)		Up to 28 days
Secondary	Overall Severity of Disease Score	Subjects recorded a severity score for 10 flu symptoms on a 0-3 scale BID for 7-14 days.The severity score for each symptom was multiplied by the number of hours scored at that severity for the entire time the subject maintained a diary (a sneezing score of 1 for 12 hours and 0 for 10 hours =1*12 + 0*10=12). This is symptom severity score*hours.Symptom severity score*hours for each of the symptoms were added for an overall symptom severity score*hours (if symptom severity score*hours for 10 symptoms were 12, 10, 9, 8, 7, 10, 10, 10, 5, 5, overall symptom severity score*hours=86).Overall symptom severity score*hours were divided by the number of hours that the subject kept a diary for a standardized continuous measure of severity of the course of illness (if overall symptom severity score*hours=86 and the subject maintained a diary for 100 hours Overall Severity of Disease Score=0.86). Overall Severity of Disease Score can range 0-30 with higher scores indicating more severe symptoms.	Up to 14 days
Secondary	Time Lost From Work (Subjects With Confirmed Influenza)		Up to 28 days
Secondary	Complications of Influenza Including Secondary Illnesses, Antibiotic Use and Hospitalizations (Subjects With Confirmed Influenza)		Up to 28 days
Secondary	Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza)		28 days
Secondary	Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza)		4 days