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| Sponsors and Collaborators: |
International Centre for Diarrhoeal Disease Research, Bangladesh Centers for Disease Control and Prevention |
|---|---|
| Information provided by: | International Centre for Diarrhoeal Disease Research, Bangladesh |
| ClinicalTrials.gov Identifier: | NCT00707941 |
Purpose
Background In preparation for a global influenza pandemic, there is an urgent need for representative data from populations and settings where the pandemic is most likely to arise. There are no data on oseltamivir efficacy from Asian urban slum populations concerning duration of illness and viral shedding, nor whether efficacy depends on starting treatment < 48 hours or ≥ 48 hours after illness onset. Finally, there are no data on the capacity of the drug, in such settings, to affect household and community transmission rates.
Aims and Objectives This proposal aims to compare the duration of clinical illness among patients treated with oseltamivir vs placebo < 48 hours and ≥ 48 hours after illness onset. It will compare the duration of viral shedding among all treatment groups vs placebo, risk of transmission to household contacts by treatment group and whether neuraminidase inhibitor use creates resistance. Secondarily it aims to measure the effect on influenza.
Design and Methods A double-blind placebo controlled clinical trial design among a population in an urban slum under current influenza disease burden surveillance will be enrolled. Infection status will be confirmed by rRT-PCR. Patients ≥ 1 year old will be randomised to < 48 hour and ≥ 48 hour treatment arms. Family members and neighbours will also be assessed by PCR and a basic reproductive number calculated (R0).
Relevance These findings will address whether oseltamivir can affect illness duration and severity, affect transmission, incidence and resistance in high risk urban Asian settings where a pandemic is most likely to arise.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Pneumonia Lower Respiratory Tract Infection Upper Respiratory Tract Infection Viral Shedding |
Drug: Oseltamivir Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy of Oseltamivir in Reducing the Duration of Clinical Illness, Viral Shedding, and Transmissibility Reduction Within Households Among Participants in an Influenza Disease Burden Surveillance Cohort in Urban Dhaka, Bangladesh |
| Estimated Enrollment: | 700 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Oseltamivir for 5 days for patients with illness duration < 48 hours
|
Drug: Oseltamivir
Children ≤12 years: Suspension by Weight (Kg) as follows: Dose X 5 days Volume (ml) < 15kg = 30 mg PO BID (2.5 ml) 15kg - 22kg = 45 mg PO BID (3.75 ml) 23kg - 39kg = 60 mg PO BID (5 ml) Patients≥12 years: 75 mg capsules as follows: 1 cap (75 mg) PO BID X 5 days ≥ 40 75 mg PO BID 6.25 |
|
2: Placebo Comparator
Placebo for 5 days for patients with illness duration < 48 hours
|
Drug: Placebo
Children < 12 years, suspension by weight (kg) as follows: Dose X 5 days Volume (ml) < 15kg = 30 mg PO BID (2.5 ml) 15kg - 22kg = 45 mg PO BID (3.75 ml) 23kg - 39kg = 60 mg PO BID (5 ml) Patients≥12 years: 75 mg capsules as follows 1 cap (75 mg) PO BID X 5 days ≥ 40 75 mg PO BID 6.25 |
|
3: Experimental
Oseltamivir for 5 days for patients with illness duration ≥ 48 hours
|
Drug: Oseltamivir
Children ≤12 years: Suspension by Weight (Kg) as follows: Dose X 5 days Volume (ml) < 15kg = 30 mg PO BID (2.5 ml) 15kg - 22kg = 45 mg PO BID (3.75 ml) 23kg - 39kg = 60 mg PO BID (5 ml) Patients≥12 years: 75 mg capsules as follows: 1 cap (75 mg) PO BID X 5 days ≥ 40 75 mg PO BID 6.25 |
|
4: Placebo Comparator
Placebo for 5 days for patients with illness duration ≥ 48 hours
|
Drug: Placebo
Children < 12 years, suspension by weight (kg) as follows: Dose X 5 days Volume (ml) < 15kg = 30 mg PO BID (2.5 ml) 15kg - 22kg = 45 mg PO BID (3.75 ml) 23kg - 39kg = 60 mg PO BID (5 ml) Patients≥12 years: 75 mg capsules as follows 1 cap (75 mg) PO BID X 5 days ≥ 40 75 mg PO BID 6.25 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: W. Abdullah Brooks, MD, MPH | 88 02 988 1662 | abrooks@icddrb.org |
| Contact: Alicia G Fry, MD, MPH | 404 639 2680 | agf1@cdc.gov |
| Bangladesh | |
| Kamalapur Urban Site, ICDDR,B | Recruiting |
| Dhaka, Bangladesh, 1000 | |
| Contact: Salam Khan 88 02 988 6498 salamk@icddrb.org | |
| Principal Investigator: W. Abdullah Brooks, MD, MPH | |
| Principal Investigator: | W. Abdullah Brooks, MD, MPH | ICDDR, B |
More Information
| Responsible Party: | ICDDR,B ( W. Abdullah Brooks, MD, MPH ) |
| Study ID Numbers: | 2008-007, 1U01IP000127-01 |
| Study First Received: | June 29, 2008 |
| Last Updated: | June 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00707941 |
| Health Authority: | Bangladesh: Ethical Review Committee |
|
Influenza like illness Pneumonia Bronchiolitis Upper respiratory tract illness Otitis media |
Viral shedding Nasopharyngeal wash Viral culture PCR |
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Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Otitis Bronchiolitis |
Otitis Media Influenza, Human Orthomyxoviridae Infections Pneumonia Oseltamivir |
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Anti-Infective Agents Communicable Diseases RNA Virus Infections Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions |
