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InfluenzaNCT00428831

Clinical IGSP-CHOP Boston

An observational study of Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to look at relationships between types of flu viruses and characteristics of infected patients, including vaccination status, organ system involvement, and disease severity. In this study, 500 patients with respiratory illnesses will have nose/throat fluid samples collected. Read more about this study

Who is it for?
Ages 30 days and older
Conditions the study is for
Influenza
How many people
500 participants
Where
2 sitesUnited States
Study dates
Feb 2007to Sep 2008
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 30 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Will recruit patients of both genders and of any health status. Will be recruited at Children's Hospital Boston and at Beth Israel Deaconess Medical Center. At Children's Hospital, patients 30 days to 5 years of age will be recruited; at Beth Israel Deaconess Medical Center patients of any age will be eligible.

Who may be able to join

  • For pediatric population: Age of patient: 30 days - 5 years; for adult population: any age
  • Illness onset within past 5 days
  • Symptoms of fever (>=38°) plus one or more of the following: cough, runny nose, congestion, or sneezing (twice or more within one day). These symptoms must be present at the time of presentation to the emergency department (ED) or admission to the hospital.
  • Patient or parent/guardian is able to give informed consent

Who cannot join

  • Pediatric patient or non-verbal adult is not accompanied by a caregiver
  • Participant/caregiver cannot be reached by phone in 7-10 days
  • Patient has a condition that can compromise respiratory function or the handling of respiratory secretions (e.g., severe cognitive dysfunction, spinal cord injuries, or other neuromuscular disorders)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Children's Hospital Boston - Infectious Diseases

    Boston, Massachusetts, 02115-5711

  • Beth Israel Deaconess Medical Center - Medicine - Infectious Disease

    Boston, Massachusetts, 02215-5400

Other trials in United States

About this study

Official title: Clinical Correlates to Influenza Genomic Data

The main purpose of this study is to look at relationships between types of flu viruses and characteristics of infected patients, including vaccination status, organ system involvement, and disease severity. In this study, 500 patients with respiratory illnesses will have nose/throat fluid samples collected. At Children's Hospital Boston, patients 30 days to 5 years of age will be recruited; at Beth Israel Deaconess Medical Center, patients of any age will be eligible. The researchers will compare the symptoms of infection by similar flu virus types and look at differences in the flu virus types between the 2 age groups of patients. The researchers will also look at whether any flu virus types first show up in the children prior to infecting the adults. Hopefully this study will improve understanding of how flu viruses develop, spread, and cause disease. This information may help the development of more effective flu vaccines, prevention measures, and treatments.

Read the detailed description

There is evidence that the pediatric population, in particular, may play an essential role in influenza transmission. One recent study showed that children between the ages of 3 and 4 years were consistently the first population group to be affected by influenza illness over several winter seasons. In addition, influenza illness in children less than 5 years of age was the strongest predictor of mortality among adults. Collecting samples from adults as well as children in the pre-school age group would enable researchers to further examine the specific role this population plays in the evolution of influenza virus lineages and the development of dominant strains. In this prospective observational study, the researchers are therefore proposing to collect samples from pediatric patients at Children's Hospital and from adults at Beth Israel Deaconess Medical Center. This will enable the researchers to compare the clinical manifestations resulting from infection by similar strains and to examine differences in the genomic sequences of the viruses between the two population groups. The primary objective of this study is to conduct a pilot study to explore correlations between influenza viral strains and clinical characteristics of infected patients, including vaccination status, organ system involvement, and disease severity. With regard to outcome measures, the researchers will determine rates of clinical features associated with specific viral strains. The clinical characteristics the researchers will examine are vaccination status, illness symptoms (presence of fever, cough, runny nose/ stuffy nose, headache, myalgia, fatigue), initial O2 saturation, treatment with antibiotics or antivirals, hospitalization, daycare or kindergarten attendance, exposure to elderly persons, and length of illness. The secondary study objective is to conduct a pilot study to compare the influenza genomic sequences and clinical data from pediatric and adult patients infected with influenza and to explore potential viral transmission patterns between these two populations. With regard to the outcome measures, the researchers will determine rates of clinical features and of specific viral strains in the pediatric and adult populations. The clinical characteristics the researchers will examine are the same as in the primary objective. The researchers will also identify any temporal patterns in the infections caused by specific viral strains in the two groups. Specifically, the researchers will examine whether any viral strains first emerge in the pediatric population prior to infecting the adult group. A total of 500 patients with respiratory illnesses will be recruited at Children's Hospital Boston and at Beth Israel Deaconess Medical Center. At Children's Hospital, patients 30 days to 5 years of age will be recruited; at Beth Israel Deaconess Medical Center patients of any age will be eligible. The researchers will recruit patients of both genders and of any health status. Respiratory samples and clinical information will be collected from each participant. It is hoped that this study will help further the researchers' understanding of how influenza viruses evolve, spread, and cause disease. In the future, this may help in the development of more effective vaccines and prevention measures, as well as treatments for people infected with influenza.

Conditions
Influenza
Keywords
influenza, genomic data, nasopharyngeal aspirate
Medical subject headings
Influenza, Human

What participants receive

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

Study groups in NCT00428831
Study groupRoleWhat they receive
1Patients with respiratory illnesses.

What is being measured

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

  1. Patient's length of illness, symptoms, medication use, influenza vaccination status, initial O2 saturation, hospitalization, daycare or kindergarten attendance, exposure to elderly persons, and length of illness.

    Measured: Enrollment and Follow up phone call.

Secondary outcomes (1)
  1. Rates of clinical features and of specific viral strains in the pediatric and adult populations.

    Measured: Enrollment and Follow up phone call.

Timeline

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

  1. First posted30 Jan 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionSep 2008
  4. Study completionSep 2008

Resources

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
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00428831
Sponsor's protocol ID
06-0096
Status last verified
Sep 2008
First submitted
26 Jan 2007
Last updated
20 Dec 2013
Results posted
No

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 2 sites in United States.

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 3 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 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Patient's length of illness, symptoms, medication use, influenza vaccination status, initial O2 saturation, hospitalization, daycare or kindergarten attendance, exposure to elderly persons, and length of illness. (time frame: Enrollment and Follow up phone call.). It is what the study was designed to measure, not a finding.

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 20 Dec 2013.

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