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Insufficient enrollment during 2009-2010 flu season, new study initiated.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitazoxanide | Active Comparator |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitazoxanide | Drug | Tablet, 500 mg with food twice daily for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection) | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus) | Up to 28 days | |
| Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects) | Up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-François Rossignol, MD, PhD | The Romark Institute for Medical Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Research Center at Asthma and Allergy Associates, P.C. | Elmira | New York | 14901 | United States |
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Patients were enrolled at 11 primary care health centers throughout the United States in the last months of the 2009/2010 flu season
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| ID | Title | Description |
|---|---|---|
| FG000 | Nitazoxanide | Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days |
| FG001 | Placebo | Placebo : Tablet, twice daily with food for 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nitazoxanide | Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days |
| BG001 | Placebo | Placebo : Tablet, twice daily with food for 5 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection) | All subjects with laboratory confirmed influenza who took at least one dose of study medication. | Posted | Median | Inter-Quartile Range | hours | Up to 28 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nitazoxanide | Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment | Abdominal distension, Abdominal pain upper, Diarrhea, Dysgeusia, Nausea, Oropharyngeal pain |
Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Ayers | Romark Laboratories, L.C. | 813-282-8544 | Marc.Ayers@romark.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C041747 | nitazoxanide |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Placebo | Drug | Tablet, twice daily with food for 5 days |
|
|
| Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza) | Up to 28 days |
| 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 |
| Time Lost From Work (Subjects With Confirmed Influenza) | Up to 28 days |
| Complications of Influenza Including Secondary Illnesses, Antibiotic Use and Hospitalizations (Subjects With Confirmed Influenza) | Up to 28 days |
| Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza) | 28 days |
| Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza) | 4 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
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| Secondary | Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus) | All subjects with any laboratory confirmed viral infection who took at least one dose of study medication. | Posted | Median | Inter-Quartile Range | hours | Up to 28 days |
|
|
|
| Secondary | Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects) | All subjects who received at least one dose of study medication. | Posted | Median | Inter-Quartile Range | hours | Up to 28 days |
|
|
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| Secondary | Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza) | All subjects with laboratory confirmed influenza who received at least one dose of study medication. | Posted | Median | Inter-Quartile Range | hours | 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. | All subjects with laboratory confirmed influenza who received at least one dose of study medication. | Posted | Mean | Standard Deviation | overall severity score | Up to 14 days |
|
|
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| Secondary | Time Lost From Work (Subjects With Confirmed Influenza) | All subjects with laboratory confirmed influenza who received at least one dose of study medication. | Posted | Least Squares Mean | 95% Confidence Interval | hours | Up to 28 days |
|
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|
| Secondary | Complications of Influenza Including Secondary Illnesses, Antibiotic Use and Hospitalizations (Subjects With Confirmed Influenza) | All subjects with laboratory confirmed influenza who received at least one dose of study medication. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
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| Secondary | Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza) | All subjects with laboratory confirmed influenza enrolled in the intensive virologic follow up substudy who received at least one dose of study medication. | Posted | Median | Inter-Quartile Range | hours | 28 days |
|
|
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| Secondary | Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza) | All subjects with laboratory confirmed influenza enrolled in the intensive virologic follow up substudy who received at least one dose of study medication. | Posted | Mean | Standard Deviation | Quantitative PCR RNA Copies | 4 days |
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| 0 |
| 37 |
| 9 |
| 37 |
| EG001 | Placebo | Placebo : Tablet, twice daily with food for 5 days | 0 | 42 | 6 | 42 |
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| General disorders and administration site conditions | General disorders | Systematic Assessment | Malaise, Pyrexia |
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| Infections and infestations | Ear and labyrinth disorders | Systematic Assessment | Ear infection, Sinusitis |
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| Muscoloskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment | Arthralgia |
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| Nervous system disorders | Nervous system disorders | Systematic Assessment | Headache |
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| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment | Chromaturia, Pollakiuria |
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| Reproductive system and breast disorders | Reproductive system and breast disorders | Systematic Assessment | Epididymitis |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Cough, Dyspnoea, Productive cough |
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Presentation and/or publication is encouraged provided the Sponsor is notified in advance and given the opportunity to review the manuscript or abstract 30 days prior to its submission for presentation at a scientific meeting or for publication in a scientific journal. The investigators will have complete autonomy regarding the content and wording including the decision of whether or not to publish.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| Day 4 |
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