Antiviral Therapy for Influenza A H1N1

NCT00985582 | Completed DMC

• 1 other identifier: SEA032
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

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

Conditions

Influenza A Virus Infection

Keywords

Influenza A Virus (H1N1)

Outcome Measures

Primary Outcomes (1)

• Viral clearance on Day 5 on all collected nasopharyngeal samples, assessed by RT PCR for new influenza A(H1N1)

  12 months

Secondary Outcomes (1)

• Viral clearance on Day 1, 2, 3, 4, 5 (H1N1) on nose and throat swab, assessed by RT PCR.

  12 months

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Lack of informed consent

Sponsors & Collaborators

• South East Asia Infectious Disease Clinical Research Network: lead
• Wellcome Trust: collaborator

Study Sites (1)

National Institute for Infectious and Tropical Diseases (NIITD), Viet Nam

Hanoi, Vietnam

Location

Related Publications (5)

• Lackenby A, Thompson CI, Democratis J. The potential impact of neuraminidase inhibitor resistant influenza. Curr Opin Infect Dis. 2008 Dec;21(6):626-38. doi: 10.1097/QCO.0b013e3283199797.

  PMID: 18978531 BACKGROUND

• Ferraris O, Lina B. Mutations of neuraminidase implicated in neuraminidase inhibitors resistance. J Clin Virol. 2008 Jan;41(1):13-9. doi: 10.1016/j.jcv.2007.10.020. Epub 2007 Dec 11.

  PMID: 18055254 BACKGROUND

• Shiraishi K, Mitamura K, Sakai-Tagawa Y, Goto H, Sugaya N, Kawaoka Y. High frequency of resistant viruses harboring different mutations in amantadine-treated children with influenza. J Infect Dis. 2003 Jul 1;188(1):57-61. doi: 10.1086/375799. Epub 2003 Jun 23.

  PMID: 12825171 BACKGROUND

• Hurt AC, Ho HT, Barr I. Resistance to anti-influenza drugs: adamantanes and neuraminidase inhibitors. Expert Rev Anti Infect Ther. 2006 Oct;4(5):795-805. doi: 10.1586/14787210.4.5.795.

  PMID: 17140356 BACKGROUND

• Dutkowski R, Thakrar B, Froehlich E, Suter P, Oo C, Ward P. Safety and pharmacology of oseltamivir in clinical use. Drug Saf. 2003;26(11):787-801. doi: 10.2165/00002018-200326110-00004.

  PMID: 12908848 BACKGROUND

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

Study Officials

• Jeremy Farrar, MD

  Oxford University Clinical Research Unit Ho Chi Minh City Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 28, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 27, 2011

Record last verified: 2011-05

Locations

VN (1)