Trial record 6 of 135 for:    novel influenza a (h1n1)

Antiviral Therapy for Influenza A H1N1 (SEA032)

This study has been completed.
Sponsor:
Collaborator:
Wellcome Trust
Information provided by:
South East Asia Infectious Disease Clinical Research Network
ClinicalTrials.gov Identifier:
NCT00985582
First received: September 25, 2009
Last updated: May 25, 2011
Last verified: May 2011
  Purpose

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
Influenza A Virus Infection

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by South East Asia Infectious Disease Clinical Research Network:

Primary Outcome Measures:
  • Viral clearance on Day 5 on all collected nasopharyngeal samples, assessed by RT PCR for new influenza A(H1N1) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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

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


Enrollment: 181
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985582

Locations
Vietnam
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
Investigators
Principal Investigator: Jeremy Farrar, MD Oxford University Clinical Research Unit Ho Chi Minh City Vietnam
  More Information

Additional Information:
Publications:
Responsible Party: Prof. Jeremy Farrar FRCP Dphil / Principal Investigator, Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam
ClinicalTrials.gov Identifier: NCT00985582     History of Changes
Other Study ID Numbers: SEA032
Study First Received: September 25, 2009
Last Updated: May 25, 2011
Health Authority: United Kingdom: Research Ethics Committee
Vietnam: Ministry of Health
Thailand: Ethical Committee

Keywords provided by South East Asia Infectious Disease Clinical Research Network:
Influenza A Virus (H1N1)

Additional relevant MeSH terms:
Influenza, Human
Respiratory Tract Infections
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Infection
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014