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Oseltamivir Randomised Controlled Efficacy Trial

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ClinicalTrials.gov Identifier: NCT00707941
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : July 12, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Influenza Pneumonia Lower Respiratory Tract Infection Upper Respiratory Tract Infection Viral Shedding Drug: Oseltamivir Drug: Placebo Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2008
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Oseltamivir
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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



Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Duration of viral shedding among all treatment groups vs placebo [ Time Frame: 18 months ]
  3. Compare the risk of transmission to household contacts by treatment group vs placebo [ Time Frame: 18 months ]
  4. The effect of neuraminidase inhibitor use on the emergence of resistance [ Time Frame: 18 months ]
  5. Clinical complications associated with influenza among all treatment groups vs placebo [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Effect of acute neuraminidase inhibitor treatment on influenza incidence in the population [ Time Frame: 18 months ]
  2. Transmission of resistant mutations within households [ Time Frame: 18 months ]
  3. Viral shedding in stool and effect of oseltamivir on stool shedding if present [ Time Frame: 18 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707941


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

Additional Information:
Publications:
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 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: June 2008

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:
Infection
Communicable Diseases
Influenza, Human
Pneumonia
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Lung Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action