Trial · NCT01227421
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects | Up to 28 days | The primary efficacy analysis for this study was to demonstrate the efficacy of Nitazoxanide (NTZ) administered as 300 mg b.i.d. for 5 days or 600 mg b.i.d. for 5 days in reducing the time to resolution of all clinical symptoms of influenza in patients with laboratory confirmed influenza infection |
| Secondary | Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects | at least 28 days | Time in hours (Median and Interquartile range) |
| Secondary | Mean Change (Standard Deviation)in 50% Tissue Culture Infective Dose (TCID50) Viral Titer From Baseline | 7 days | Change in viral titer presented as logarithm with base 10 (log10) 50% Tissue Culture Infective Dose (TCID50) |
| Secondary | Mean Change in RT-PCR (Reverse Transcription Polymerase Chain Reaction) Viral Titer From Baseline | 7 days | Change in viral titer logarithm with base 10 (log10) Ribonucleic Acid (RNA)copies |
| Secondary | Time to Cessation of Viral Shedding Measure by 50% Tissue Culture Infective Dose (TCID50) | 28 days | Median time in hours |
| Secondary | Time to Return to Normal Daily Activities | 28 days | Time in hours as reported by patient |
| Secondary | Symptom Severity Score Hours | 28 days | Sum of the symptom severity score hours from first dose to resolution of symptoms. Patients rated each symptom's severity on a score from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe). Total symptom severity score hours were calculated by multiplying the sum of the severity scores by duration of symptoms. |
| Secondary | Time Loss From Work | 28 days | Time loss from work |
| Secondary | Complications of Influenza | 28 days | Proportion of patients with a complication of influenza during the course of the study |
| Secondary | Influenza Antibody Response Titer Change: Influenza A 2009 H1N1 | 28 days | change in influenza antibody titer for Influenza A 2009 H1N1 |
| Secondary | Influenza Antibody Response: Influenza A H3N2 | 28 days | Change in antibody titer for Influenza A H3N2 |
| Secondary | Influenza Antibody Response: Influenza B | 28 days | Change in antibody titer for Influenza B |
| Secondary | Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A 2009 H1N1 | 28 days | Proportion of patients seroprotected or seroconverted at day 28 |
| Secondary | Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A H3N2 | 28 days | Proportion of patients seroprotected and seroconverted at day 28 |
| Secondary | Influenza Antibody Response: Seroprotection and Seroconversion for Influenza B | 28 days | Proportion of patients seroprotected and seroconverted at day 28 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01227421/registered