COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Antiviral Therapy for Influenza A H1N1 (SEA032)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00985582
Recruitment Status : Completed
First Posted : September 28, 2009
Last Update Posted : May 27, 2011
Wellcome Trust
Information provided by:
South East Asia Infectious Disease Clinical Research Network

Brief Summary:

The aims of this study are to characterise the clinical efficacy and virological clearance dynamics of orally administered oseltamivir in patients with influenza caused by novel influenza A(H1N1). This research will also contribute to enhancing research capacity in affected countries.

The objectives are to assess the:

  • viral replication levels over time in affected patients
  • antiviral efficacy of oral oseltamivir
  • patterns and compartments of viral shedding, tissue distribution
  • innate inflammatory response and relation to viral replication
  • kinetics of antibody response
  • antiviral sensitivity of influenza viruses at baseline and during oseltamivir treatment using in vitro and molecular methods
  • pharmacokinetic characteristics of oseltamivir and oseltamivir carboxylate
  • all cause in hospital mortality
  • clinical and radiological features, disease course and outcome
  • length of stay in hospital
  • risk factors associated with development of severe disease and death

Condition or disease
Influenza A Virus Infection

Detailed Description:

Any patient over 1 year of age who presents to a participating institution with confirmed influenza A and who meets the study inclusion/exclusion criteria may be approached for informed consent. Choice of antiviral is up to the study physician. Children aged 1-6 years and asthmatics should receive oseltamivir. The weight- and age-adjusted dosage used will be that approved for treatment of uncomplicated seasonal influenza, and doses will be administered twice daily for 5 days for patients with normal renal function. All patients who are clinical and/or virologic failures at day 5 will be treated for an additional 5 days of antivirals. After coming off antiviral therapy patients can be discharged at day 10 if deemed ready by study physicians and they are virologically negative.

During the course of treatment study evaluations will be performed to determine primary efficacy end points including viral clearance on Day 5 on all collected nasopharyngeal samples, assessed by RT PCR for novel H1N1 influenza AND no clinical features of clinical failure. Evaluations will also be performed to determine secondary viral, serological, clinical efficacy, safety and pharmacokinetic endpoints.

Patients will be followed up for up to 6 months after discharge for a clinical assessment, pulmonary function and outcome of pregnancy.

The protocol will be reviewed after 6 months from starting or after 100 patients with Influenza A are recruited.

Layout table for study information
Study Type : Observational
Actual Enrollment : 181 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Antiviral Treatment in Adults and Children With Novel Influenza A (H1N1) Respiratory Tract Infection - a Clinical, Virological and Pharmacokinetic Study.
Study Start Date : September 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Primary Outcome Measures :
  1. Viral clearance on Day 5 on all collected nasopharyngeal samples, assessed by RT PCR for new influenza A(H1N1) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Viral clearance on Day 1, 2, 3, 4, 5 (H1N1) on nose and throat swab, assessed by RT PCR. [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Nasal swabs, throat swabs, nasopharyngeal aspirates, rectal swabs, urine, blood, will be obtained for virological analyses, according to the age group specific study schedules

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This is a single arm clinical and virological study assessing the use of oral oseltamivir or other agents in the treatment of patients with novel influenza A(H1N1) infection.

Any patient over 1 year of age with confirmed novel influenza A(H1N1) in whom appropriate informed consent to collect data and samples is obtained. The protocol will be reviewed after 6 months from starting or after 100 patients with new influenza A(H1N1) are recruited.


Inclusion Criteria:

  • Adults, including pregnant and breast feeding women, and Children aged ≥ 12 months when first seen with an acute febrile respiratory tract illness (ARI) of any severity and influenza A, virologically proven on a respiratory specimen according to hospital procedure, which is suspected to be novel influenza A(H1N1)
  • A positive influenza A H1 swine screening reverse transcriptase polymerase chain reaction (RT PCR) or conventional PCR assay on one respiratory specimen : NPA, NP swab, nasal wash, nasal swab and throat swab
  • Underlying illnesses including HIV
  • Prescribed oseltamivir prior to presentation

Exclusion Criteria:

  • Lack of informed consent

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 identifier (NCT number): NCT00985582

Layout table for location information
National Institute for Infectious and Tropical Diseases (NIITD), Viet Nam
Hanoi, Vietnam
Sponsors and Collaborators
South East Asia Infectious Disease Clinical Research Network
Wellcome Trust
Layout table for investigator information
Principal Investigator: Jeremy Farrar, MD Oxford University Clinical Research Unit Ho Chi Minh City Vietnam
Layout table for additonal information
Responsible Party: Prof. Jeremy Farrar FRCP Dphil / Principal Investigator, Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam Identifier: NCT00985582    
Other Study ID Numbers: SEA032
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: May 27, 2011
Last Verified: May 2011
Keywords provided by South East Asia Infectious Disease Clinical Research Network:
Influenza A Virus (H1N1)
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases