Oseltamivir Randomised Controlled Efficacy Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00707941
First received: June 29, 2008
Last updated: July 11, 2011
Last verified: June 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Duration of clinical illness among patients treated with oseltamivir vs placebo < 48 hours as well as ≥48 hours after illness onset [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Duration of viral shedding among all treatment groups vs placebo [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Compare the risk of transmission to household contacts by treatment group vs placebo [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • The effect of neuraminidase inhibitor use on the emergence of resistance [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Clinical complications associated with influenza among all treatment groups vs placebo [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of acute neuraminidase inhibitor treatment on influenza incidence in the population [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Transmission of resistant mutations within households [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Viral shedding in stool and effect of oseltamivir on stool shedding if present [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: May 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

Placebo Comparator: 2
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

Experimental: 3
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

Placebo Comparator: 4
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
Criteria

Inclusion Criteria:

  • Persons at least one year old residing in randomly selected households with at least one major illness sign, or if absent at least two minor illness signs who are rapid test positive for either influenza A or influenza B.

Exclusion Criteria:

  • Persons with a history of non-febrile convulsions or
  • Persons who are taking anticonvulsive agents, or
  • Persons who have a nonrespiratory comorbid condition requiring immediate medical intervention, or
  • Persons who are pregnant.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00707941

Locations
Bangladesh
Kamalapur Urban Site, ICDDR,B
Dhaka, Bangladesh, 1000
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: W. Abdullah Brooks, MD, MPH International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: W. Abdullah Brooks, MD, MPH, ICDDR,B
ClinicalTrials.gov Identifier: NCT00707941     History of Changes
Other Study ID Numbers: 2008-007, 1U01IP000127-01
Study First Received: June 29, 2008
Last Updated: July 11, 2011
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Influenza like illness
Pneumonia
Bronchiolitis
Upper respiratory tract illness
Otitis media
Viral shedding
Nasopharyngeal wash
Viral culture
PCR

Additional relevant MeSH terms:
Influenza, Human
Pneumonia
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Lung Diseases
Infection
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014