Phase 3
N=624
Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01227421 ↗Enrolled (actual)
624
Serious AEs
0.3%
Results posted
Jan 2014
Primary outcome: Primary: Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects — 109.1; 116.7; 95.5 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nitazoxanide (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Romark Laboratories L.C.
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects |
109.1; 116.7; 95.5 | — |
| SECONDARY Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects |
84; 81; 60; 48; 42; 43 | — |
| SECONDARY Mean Change (Standard Deviation)in 50% Tissue Culture Infective Dose (TCID50) Viral Titer From Baseline |
-0.58; -0.03; -1.11; -1.26; -1.21; -1.84 | — |
| SECONDARY Mean Change in RT-PCR (Reverse Transcription Polymerase Chain Reaction) Viral Titer From Baseline |
-0.63; -0.22; -0.73; -1.34; -0.92; -1.64 | — |
| SECONDARY Time to Cessation of Viral Shedding Measure by 50% Tissue Culture Infective Dose (TCID50) |
77.0; 91.3; 71.8 | — |
| SECONDARY Time to Return to Normal Daily Activities |
84.2; 82.1; 84.0 | — |
| SECONDARY Symptom Severity Score Hours |
1035.1; 1220.9; 1125.2 | — |
| SECONDARY Time Loss From Work |
2.6; 3.0; 3.3 | — |
| SECONDARY Complications of Influenza |
10; 3; 7; 6; 6; 2 | — |
| SECONDARY Influenza Antibody Response Titer Change: Influenza A 2009 H1N1 |
2; 2; 2 | — |
| SECONDARY Influenza Antibody Response: Influenza A H3N2 |
8; 16; 16 | — |
| SECONDARY Influenza Antibody Response: Influenza B |
4; 3; 4 | — |
| SECONDARY Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A 2009 H1N1 |
11; 14; 12; 11; 12; 11 | — |
| SECONDARY Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A H3N2 |
14; 12; 12; 13; 12; 12 | — |
| SECONDARY Influenza Antibody Response: Seroprotection and Seroconversion for Influenza B |
14; 13; 13; 12; 10; 13 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01227421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.