Influenza A Virus InfectionSEA032NCT00985582
Antiviral Therapy for Influenza A H1N1
An observational study of Influenza A Virus Infection, run by South East Asia Infectious Disease Clinical Research Network at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Influenza A Virus Infection
- How many people
- 181 participants
- Where
- 1 siteVietnam
- Study dates
- Sep 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
National Institute for Infectious and Tropical Diseases (NIITD), Viet Nam
Hanoi
About this study
Official title: Antiviral Treatment in Adults and Children With Novel Influenza A (H1N1) Respiratory Tract Infection - a Clinical, Virological and Pharmacokinetic Study.
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
Read the 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.
- Conditions
- Influenza A Virus Infection
- Keywords
- Influenza A Virus (H1N1)
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral clearance on Day 5 on all collected nasopharyngeal samples, assessed by RT PCR for new influenza A(H1N1)
Measured: 12 months
Secondary outcomes (1)
Viral clearance on Day 1, 2, 3, 4, 5 (H1N1) on nose and throat swab, assessed by RT PCR.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Influenza A Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- South East Asia Infectious Disease Clinical Research Network
- Sponsor type
- Research network
- Collaborators
- Wellcome Trust
- Investigators
- Jeremy Farrar, MD, Principal investigator, Oxford University Clinical Research Unit Ho Chi Minh City Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985582
- Sponsor's protocol ID
- SEA032
- Acronym
- SEA032
- Status last verified
- May 2011
- First submitted
- 25 Sep 2009
- Last updated
- 27 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18978531Ferraris 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.
PubMed 18055254Shiraishi 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.
PubMed 12825171Hurt 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.
PubMed 17140356Dutkowski 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.
PubMed 12908848
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiviral Treatment in Adults and Children With Novel Influenza A (H1N1) Respiratory Tract Infection - a Clinical, Virological and Pharmacokinetic Study.
- ClinicalTrials.gov ID
- NCT00985582
- Acronym / sponsor ID
- SEA032 / SEA032
- Conditions
- Influenza A Virus Infection
- Keywords
- Influenza A Virus (H1N1)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- South East Asia Infectious Disease Clinical Research NetworkResearch network
- Collaborators
- Wellcome Trust
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Viral clearance on Day 5 on all collected nasopharyngeal samples, assessed by RT PCR for new influenza A(H1N1)
Time frame: 12 months
1 secondary outcome
Viral clearance on Day 1, 2, 3, 4, 5 (H1N1) on nose and throat swab, assessed by RT PCR.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2011.
- Background: PubMed 18978531Lackenby 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.
- Background: PubMed 18055254Ferraris 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.
- Background: PubMed 12825171Shiraishi 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.
- Background: PubMed 17140356Hurt 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.
- Background: PubMed 12908848Dutkowski 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Farrar, MD principal investigator
Oxford University Clinical Research Unit Ho Chi Minh City Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza A Virus Infection, run by South East Asia Infectious Disease Clinical Research Network at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral clearance on Day 5 on all collected nasopharyngeal samples, assessed by RT PCR for new influenza A(H1N1) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00985582, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2011; AzTrials last refreshed its copy on 7 Nov 2026.