Status:
COMPLETED
Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
Lead Sponsor:
Romark Laboratories L.C.
Conditions:
Influenza
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- age 12 to 65 years
- Presence of clinical signs, respiratory symptoms and constitutional symptoms compatible with influenza infection:
- fever,
- at least one of the following respiratory symptoms: cough, sore throat, nasal discharge, nasal congestion, sneezing.
- At least one of the following constitutional symptoms: headache, myalgia, seats, chills, fatigue of any severity (mild, moderate, severe)
- Confirmation of Influenza A or B infection in the local community
- Onset of illness no more than 48 hours before presentation. Time of onset of illness is defined as either the earlier of (1) the time when the temperature was first measured as elevated, or (2) the time when the patient experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
- willing and able to comply with protocol requirements and provide informed consent
- EXCLUSION CRITERIA:
- severity of illness requiring or anticipated to require in-hospital care
- High risk of complications from influenza as follows:
- persons with asthma or other chronic pulmonary diseases
- persons with hemodynamically significant cardiac disease
- persons who have immunosuppressive disorders or receiving immunosuppressive therapy
- persons infected with Human Immunodeficiency Virus (HIV)
- persons with sickle cell anemia or other hemoglobinopathies
- persons with diseases requiring long-term aspirin therapy
- persons with chronic renal dysfunction
- persons with liver disorders
- Persons with cancer
- Persons with chronic metabolic disease such as diabetes and inherited mitochondrial disorders
- Persons with neuromuscular disorders, seizure disorders, or cognitive dysfunction
- Residents of any age of nursing homes or long-term institutions.
- Females of child bearing age who are pregnant, breastfeeding or sexually active without birth control
- vaccination for influenza or H1N1 (Swine Flu) on or after August 1, 2010
- treatment with antiviral medication such as oseltamivir, zanamivir, amantadine, or rimantadine within 30 days of screening.
- Prior treatment with nitazoxanide within 30 days prior to screening.
- subjects with active respiratory allergies or expected to require anti-allergy medications during the study period.
- known sensitivity to nitazoxanide
- subjects unable to take oral medication
- subjects with chronic kidney or liver disease
- Presence of any other pre-existing chronic infection that is undergoing or requiring medical therapy
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT01227421
Start Date
December 1 2010
End Date
May 1 2011
Last Update
October 12 2023
Active Locations (1)
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1
Health Sciences Research Center
Elmira, New York, United States, 14901