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NCT00311701 · ClinicalTrials.gov registry record

Chart Review of Antivirals for Influenza in Infants

A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
200
Enrollment target

NCT00311701: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00311701 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00311701 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
200 participants
Enrollment target

Study Summary

This retrospective study conducted in Canada and the US involves a chart review to assess the safety of oseltamivir (Tamiflu®) compared to alternate antiviral therapy, amantidine or rimantidine, administered to children less than 12 months of age with diagnosed or suspected influenza. The objectives are to describe the frequency of neurological and all other adverse events possibly related to administration of these antivirals in these infants. Investigators will also compare frequency of adverse events at various doses of oseltamivir in these children. Critical endpoints to be collected include frequency and severity of adverse events, particularly those relating to central nervous system complications. A sub-investigator will travel to each of the participating sites to collect data related to each infant's health prior to becoming ill, health status at time of influenza diagnosis, dosing regimen, reported neurological events post-dosing, and all reported adverse events post-dosing.

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2005-11
Est. Completion 2006-12

What the finished NCT00311701 record still lists

NCT00311701 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT00311701 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00311701 about?

NCT00311701 is a clinical study titled "Chart Review of Antivirals for Influenza in Infants". This retrospective study conducted in Canada and the US involves a chart review to assess the safety of oseltamivir (Tamiflu®) compared to alternate antiviral therapy, amantidine or rimantidine, administered to children less than 12 months of age with diagnosed or suspected influenza. The objectives...

What is the current status of trial NCT00311701?

This trial is currently completed. The enrollment target is 200 participants. The study started on 2005-11. Estimated completion is 2006-12.

Who is sponsoring clinical trial NCT00311701?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00311701, the US trial registry maintained by the National Library of Medicine. NCT00311701 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.