Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza - Full Text View

Sponsor:	Romark Laboratories L.C.
Information provided by:	Romark Laboratories L.C.
ClinicalTrials.gov Identifier:	NCT01056380

Purpose

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.

Condition	Intervention	Phase
Influenza	Drug: Nitazoxanide Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Nitazoxanide

U.S. FDA Resources

Further study details as provided by Romark Laboratories L.C.:

Primary Outcome Measures:

Time to resolution of all clinical symptoms of influenza (subjects with confirmed influenza infection) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to resolution of all clinical symptoms of influenza (subjects infected with any respiratory virus) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
Time to resolution of all clinical symptoms of influenza (all treated subjects) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
Time to return to normal daily activity (subjects with confirmed influenza, subjects any respiratory virus and all treated subjects) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
Severity of disease expressed in score-hours (symptom scores multiplied by duration of symptoms for subjects with confirmed influenza, subjects any respiratory virus and all treated subjects) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
Time lost from work (subjects with confirmed influenza, subjects any respiratory virus and all treated subjects) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
Complications of influenza including secondary illnesses, antibiotic use and hospitalizations (subjects with confirmed influenza, subjects any respiratory virus and all treated subjects) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
Time to cessation of viral shedding (subjects with confirmed influenza) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Change in influenza virus titer assessed by quantitative RT-PCR (subjects with confirmed influenza) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	440
Study Start Date:	January 2010
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nitazoxanide: Active Comparator	Drug: Nitazoxanide Tablets, 500 mg with food twice daily for 5 days
Placebo: Placebo Comparator	Drug: Placebo Tablet, twice daily with food for 5 days

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 guidelines or current CDC 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056380

Contacts

Contact: Celine Rossignol, MS

877-925-4642

celine.rossignol@romark.com

Locations

United States, New York
Health Sciences Research Center at Asthma and Allergy Associates, P.C.	Recruiting
Elmira, New York, United States, 14901
Contact: Christopher A Smith, MD 607-733-5086 research@allergistdocs.com
Contact: Barbara Morrison 607-733-5086 bmstudy@allergistdocs.com

Sponsors and Collaborators

Romark Laboratories L.C.

Investigators

Study Chair:

Jean-François Rossignol, MD, PhD

The Romark Institute for Medical Research

More Information

No publications provided

Responsible Party:	Romark Laboratories, L.C. ( Jean-François Rossignol, MD, PhD, Chief Science Officer )
ClinicalTrials.gov Identifier:	NCT01056380 History of Changes
Other Study ID Numbers:	RM01-2027
Study First Received:	January 23, 2010
Last Updated:	February 16, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Romark Laboratories L.C.:

influenza
influenza like illness

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2010