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InfluenzaPhase 2NCT01037634

Safety and Efficacy of Oseltamivir in Children Younger Than One Year of Age

A Phase 2 study testing Oseltamivir in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Currently, there is no standard treatment for influenza with related lower respiratory tract infection (LRTI) in children younger than one year of age, even though influenza related LRTI is a potentially fatal illness in these children. Read more about this study

Who is it for?
Ages 1 month to 12 months
Conditions the study is for
Influenza
What is being tested?
Oseltamivir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2010to Mar 2012
Phase
Phase 2
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 month to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Informed consent signed by a parent or legal guardian
  • Younger than 12 months of age when first seen with a lower respiratory tract infection (LRTI)
  • LRTI must be moderate or severe and influenza must be virologically proven by a respiratory specimen
  • History of fever within 14 days prior to presentation (although fever at presentation is not required) plus any two of the following: cough, difficulty breathing or shortness of breath, increased respiratory rate for current age, intercostal recession, use of accessory muscles, nasal flare or grunting, crepitations with or without wheezing, a consistent abnormal chest x-ray (e.g., new infiltrate, hyperinflation)
  • Virological evidence of influenza on any one of the tests specified in the protocol

Who cannot join

  • Known allergy to oseltamivir
  • Additional Exclusion Criteria for Children with Non-Avian Influenza:
  • Illness duration greater than 14 days on the day of hospital admission
  • Creatinine clearance less than 10 mL/min/1.73m2, including a requirement for dialysis or hemofiltration

About this study

Official title: Oseltamivir Treatment in Children Under One Year of Age With Moderate or Severe Influenza Lower Respiratory Tract Infection - a Clinical and Pharmacokinetic Study

Currently, there is no standard treatment for influenza with related lower respiratory tract infection (LRTI) in children younger than one year of age, even though influenza related LRTI is a potentially fatal illness in these children. This study will test a medicine for influenza in children younger than one year of age to see if it is safe and effective.

Read the detailed description

Influenza-related lower respiratory tract infection (LRTI) can cause serious illness or death in children younger than a year old. Only four medications are registered to treat influenza, and these do not have detailed recommendations for treating children younger than one year of age. One of these medications, oseltamivir, has no official recommendation for usage in children younger than one year of age, but it may be the best treatment for certain strains of influenza. A small number of children younger than one year of age have received oseltamivir in several countries with good clinical outcomes and apparently good tolerability. This study will test oseltamivir in children younger than one year of age to see if it is safe and effective.

Children younger than one year of age with influenza will be recruited for this study. Participants will receive the usual care for influenza with the addition of oseltamivir. Oseltamivir will be given orally for 5 days to children with human influenza, 7 days to children with H1N1 influenza in Vietnam, and 10 days to children with avian influenza. Participants will need to remain in the hospital between 5 and 12 days, depending on their illnesses.

Study assessments will be performed daily for 14 days with follow-up examinations occurring 1 to 2 weeks, 6 months, and 12 months after study entry. These assessments will include normal tests for children with influenza, such as blood tests and chest x-rays, but additional blood and nose, throat, and mouth samples will be collected for the study. Participants on a breathing machine will give lung samples.

Conditions
Influenza
Being tested
Oseltamivir
Keywords
Avian Influenza, H1N1 Influenza, Seasonal Influenza
Medical subject headings
Influenza, Human, Influenza in Birds, Orthomyxoviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OseltamivirDrug

    Also called Tamiflu

    3 mg/kg given orally for 5 days for seasonal influenza, 7 days for 2009 H1N1 influenza (in Vietnam only), or 10 days for avian influenza, for children whose renal function is greater than or equal to 30 mL/min/1.73m2

Study groups in NCT01037634
Study groupRoleWhat they receive
OseltamivirExperimentalParticipants will receive Oseltamivir to treat influenza.
Receives: Drug: Oseltamivir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Viral clearance of human influenza on a nose and throat swab, assessed by reverse transcriptase polymerase chain reaction (RT PCR)

    Measured: Measured on Day 5

  2. Viral clearance of H1N1 swine influenza, version found in Vietnam only, on a nose and throat swab, assessed by RT PCR

    Measured: Measured on Day 7

  3. Viral clearance of avian influenza on a nose and throat swab, assessed by RT PCR

    Measured: Measured on Day 10

Secondary outcomes (17)

  1. Time to viral clearance on a throat and nose swab, assessed by RT PCR

    Measured: Measured over 14 days

  2. The time to no detectable influenza virus by culture for the throat and nose swabs

    Measured: Measured over 14 days

  3. Change in viral load (by log10 copies/mL) over time for all virological samples, with a lower limit of detection of 1,000 copies/mL

    Measured: Measured over 14 days

  4. Viral susceptibility of cultured influenza virus to antiviral drugs, assessed by genotypical and phenotypical analyses

    Measured: Measured at baseline and post-treatment

  5. Time to fever clearance

    Measured: Measured over 14 days

  6. In-hospital mortality and mortality by follow-up

    Measured: Measured over one year

  7. Time to death

    Measured: Measured at study completion

  8. Time to trans-cutaneous O2 saturation of greater than or equal to 95% on room air

    Measured: Measured at study completion

  9. Clinical course: pneumothorax, encephalitis/encephalopathy

    Measured: Measured at study completion

  10. Number of days in hospital

    Measured: Measured at study completion

  11. Number of days ventilated

    Measured: Measured at study completion

  12. Documented serious adverse events (SAEs) and relationships to oseltamivir

    Measured: Measured at study completion

  13. Adverse events (AEs) leading to drug withdrawal

    Measured: Measured at study completion

  14. Grade 3 and 4 clinical and laboratory AEs that are probably or definitely related to oseltamivir

    Measured: Measured at study completion

  15. Skin rashes of any grade

    Measured: Measured at study completion

  16. Changes in hematological and biochemical parameters over time

    Measured: Measured at study completion

  17. Pharmacokinetic endpoints, including maximum concentration (Cmax), time of Cmax (Tmax), steady state minimum concentration (Cmin), area under the curve (AUC), and volume of distribution

    Measured: Measured at baseline, Days 1 to 4, Day 7, and Day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2009 (estimated)
  2. Study startMar 2010
  3. Primary completionMar 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01037634
Sponsor's protocol ID
SEA 022
Status last verified
Aug 2014
First submitted
18 Dec 2009
Last updated
6 Aug 2014
Results posted
No
Data monitoring committee
No

Publications

  • Broor S, Parveen S, Bharaj P, Prasad VS, Srinivasulu KN, Sumanth KM, Kapoor SK, Fowler K, Sullender WM. A prospective three-year cohort study of the epidemiology and virology of acute respiratory infections of children in rural India. PLoS One. 2007 Jun 6;2(6):e491. doi: 10.1371/journal.pone.0000491.

    PubMed 17551572

  • American Academy of Pediatrics Committee on Infectious Diseases. Antiviral therapy and prophylaxis for influenza in children. Pediatrics. 2007 Apr;119(4):852-60. doi: 10.1542/peds.2007-0224.

    PubMed 17403862

  • 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.

    PubMed 18055254

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oseltamivir in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID).

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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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 of human influenza on a nose and throat swab, assessed by reverse transcriptase polymerase chain reaction (RT PCR) (time frame: Measured on Day 5). The study lists 3 primary outcomes in all. 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 NCT01037634, which also lists 3 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 6 Aug 2014.

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