InfluenzaNCT00311701
Chart Review of Antivirals for Influenza in Infants
An observational study of Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 11 months
- Conditions the study is for
- Influenza
- How many people
- 200 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Nov 2005to Dec 2006
- 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 Up to 11 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female study participants less than 12 months of age
- Suspected or laboratory diagnosis of influenza
- Treated with oseltamivir, rimantadine or amantadine
Who cannot join
- None listed
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States15 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233-0011
MetroHealth Medical Center
Cleveland, Ohio, 44109
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9063
University of Colorado
Denver, Colorado, 80218
Cook Children's Medical Center
Fort Worth, Texas, 76104
Creighton University
Omaha, Nebraska, 68198-2162
Children's Hospital of Orange County
Orange, California, 92868
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Oregon Health Sciences University
Portland, Oregon, 97201-3098
Arkansas Children's Hospital
Pulaski, Arkansas, 72202
University of Utah
Salt Lake City, Utah, 84132
The University of Texas Health Science Center
San Antonio, Texas, 78229-3900
Children's Hospital and Health Center
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: A Retrospective Chart Review to Assess the Safety of Oseltamivir (Tamiflu®) Compared to Alternate Antiviral Therapy (Amantadine or Rimantadine) Administered to Children Less Than 12 Months of Age With Diagnosed or Suspected Influenza (CASG 113)
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.
Read the detailed description
The study is a retrospective review of charts of children less than 12 months of age that were diagnosed with influenza and treated with oseltamivir. The chart review will focus on assessment of neurological and other adverse events that may have been related to the administration of oseltamivir. A control population will consist of children less than 12 months treated with either rimantadine or amantadine. The administration of oseltamivir to children at high risk (i.e. immunocompromised hosts) less than 12 months old with influenza is frequently considered in medical practice despite the findings of neurotoxicity in a juvenile rat study. Since oseltamivir is the only active treatment against H5N1 influenza strains, it is imperative to understand the ramifications of its potential widespread use in very young infants in the event of an outbreak. This study is designed to gather documented evidence by which the circumstances of use and defined outcomes can be described. Patient selection will be made by review of hospital inpatient medical records, emergency room medical records and/or pharmacy records to identify patients less than 1 yr old dosed with oseltamivir suspension. Redacting the charts will be done in a manner that will obscure personal health information (individual identifiers) without obscuring the necessary clinical data. A separate research data collection form will be prepared on which critical information can be transcribed that would subsequently be available for analysis. Critical information to be captured at the time of initiating oseltamivir treatment includes: age, birth history, gender, underlying medical conditions, presenting influenza symptoms, if done, type of flu test and dose regime. Critical endpoints to be collected will include the frequency and severity of adverse events, particularly those relating to central nervous system complications.
- Conditions
- Influenza
- Keywords
- Influenza, pediatric
- Medical subject headings
- Influenza, Human
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startNov 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 200 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311701
- Sponsor's protocol ID
- 05-0111
- Other IDs
- CASG 113, N01AI30025C, N01AI30025
- Status last verified
- Oct 2007
- First submitted
- 5 Apr 2006
- Last updated
- 13 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review to Assess the Safety of Oseltamivir (Tamiflu®) Compared to Alternate Antiviral Therapy (Amantadine or Rimantadine) Administered to Children Less Than 12 Months of Age With Diagnosed or Suspected Influenza (CASG 113)
- ClinicalTrials.gov ID
- NCT00311701
- Acronym / sponsor ID
- 05-0111
- Conditions
- Influenza
- Keywords
- Influenza, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2005
- Study completion
- Dec 2006
- First posted
- 6 Apr 2006 (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.
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.
Detailed description
The study is a retrospective review of charts of children less than 12 months of age that were diagnosed with influenza and treated with oseltamivir. The chart review will focus on assessment of neurological and other adverse events that may have been related to the administration of oseltamivir. A control population will consist of children less than 12 months treated with either rimantadine or amantadine. The administration of oseltamivir to children at high risk (i.e. immunocompromised hosts) less than 12 months old with influenza is frequently considered in medical practice despite the findings of neurotoxicity in a juvenile rat study. Since oseltamivir is the only active treatment against H5N1 influenza strains, it is imperative to understand the ramifications of its potential widespread use in very young infants in the event of an outbreak. This study is designed to gather documented evidence by which the circumstances of use and defined outcomes can be described. Patient selection will be made by review of hospital inpatient medical records, emergency room medical records and/or pharmacy records to identify patients less than 1 yr old dosed with oseltamivir suspension. Redacting the charts will be done in a manner that will obscure personal health information (individual identifiers) without obscuring the necessary clinical data. A separate research data collection form will be prepared on which critical information can be transcribed that would subsequently be available for analysis. Critical information to be captured at the time of initiating oseltamivir treatment includes: age, birth history, gender, underlying medical conditions, presenting influenza symptoms, if done, type of flu test and dose regime. Critical endpoints to be collected will include the frequency and severity of adverse events, particularly those relating to central nervous system complications.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 11 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female study participants less than 12 months of age
- Suspected or laboratory diagnosis of influenza
- Treated with oseltamivir, rimantadine or amantadine
Key exclusion criteria (1 listed)
- None listed
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
Not reported in the source record.
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 13 May 2011.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites in 2 countries.
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 3 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 13 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 16 sites in United States, Canada. 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.
Where can I read the original study information?
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 13 May 2011.