Severe Respiratory DiseaseNCT00192439
Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk
An observational study of Severe Respiratory Disease, run by MedImmune LLC at 24 sites in 4 countries.
Trial summary
Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash aspirates in children at high risk for severe LRI disease (hospitalized at <2 years of age). Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- Severe Respiratory Disease
- What is being tested?
- High Risk Respiratory Disease
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 24 sitesin 4 countries
- Study dates
- Dec 2003to 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 1 day to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be premature (less than 36 weeks gestation) and less than or equal to 12 months of age, and/or
- Be less than or equal to 24 months of age with CHD (other than uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus) that is judged to be hemodynamically significant, and/or
- Be less than or equal to 24 months of age with CLD of prematurity (BPD) requiring medical intervention/management (i.e., supplemental oxygen, steroids, bronchodilators, or diuretics within the previous 6 months).
- Hospital admission diagnosis referable to an acute lower respiratory tract infection or cardio/respiratory illness with a presumed respiratory infection (e.g., bronchiolitis, bronchitis, or pneumonia or cardiac decompensation associated with respiratory infection); admission must occur between October 1 and June 30 for northern hemisphere sites, and between March 1 and November 30 for southern hemisphere sites.
- Study enrollment within 2 days after hospitalization.
- Admission from the community to the Pediatric ward, Neonatal Intensive Care Unit, or the Intensive Care Unit.
- Have written informed consent obtained from the parent or legal guardian prior to study entry.
Who cannot join
- Known HIV infection or a mother with known HIV infection.
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
United States16 sites
New England Medical Center
Boston, Massachusetts, 02111
The Children's Hospital
Buffalo, New York, 14222
Children's Memorial Hospital
Chicago, Illinois, 60614
Univ. of Texas Southwestern Medical Center
Dallas, Texas, 75390
The Children's Hospital
Denver, Colorado, 80218
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
Miller Children's Hospital
Long Beach, California, 90806
Lebonheur Children's Medical Center
Memphis, Tennessee, 38103
Schneider Children's Hospital, Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 80218
Rhode Island Hospital, Dept. of Pediatrics
Providence, Rhode Island, 02903
Univ. of Rochester Medical Center
Rochester, New York, 14642
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
Suny Upstate Medical Univ.
Syracuse, New York, 13210
Wake Forest Univ. School of Medicine
Winston-Salem, North Carolina, 27157
Canada4 sites
University of Alberta
Edmonton, Alberta, T6G 2J3
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Univ. of Mannitoba
Winnipeg, Manitoba, R3E 3P4
Australia3 sites
University Dept. of Paediatrics, Women's and Children's Hospital
North Adelaide, South Australia, 5006
Royal Children's Hospital, Murdoch Children's Research Institute
Parkville, Victoria, 3052
University of Western Australia
Perth, Western Australia, 6014
About this study
Official title: A Study to Describe the Incidence Rate and Clinical Features of Human Meta Pneumovirus (hMPV) Infection of the Lower Respiratory Tract in Hospitalized Children at High Risk for Severe Disease
- Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash aspirates in children at high risk for severe LRI disease (hospitalized at <2 years of age).
Read the detailed description
- A prospective, epdemiological study to estimate the incidence rate of hMPV infection as determined by RT-PCR from frozen nasal wash aspirates taken from children hospitalized with LRI who are at high risk for severe disease.
- No study drug will be administered for this study.
- Conditions
- Severe Respiratory Disease
- Being tested
- High Risk Respiratory Disease
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Risk Respiratory DiseaseBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startDec 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Respiratory DiseaseStudies 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
- Defined population
- Time perspective
- Other
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Margarita Gomez, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192439
- Sponsor's protocol ID
- MI-CP096
- Status last verified
- May 2007
- First submitted
- 12 Sep 2005
- Last updated
- 7 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Describe the Incidence Rate and Clinical Features of Human Meta Pneumovirus (hMPV) Infection of the Lower Respiratory Tract in Hospitalized Children at High Risk for Severe Disease
- ClinicalTrials.gov ID
- NCT00192439
- Acronym / sponsor ID
- MI-CP096
- Conditions
- Severe Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 19 Sep 2005 (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.
- Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash aspirates in children at high risk for severe LRI disease (hospitalized at <2 years of age).
Detailed description
- A prospective, epdemiological study to estimate the incidence rate of hMPV infection as determined by RT-PCR from frozen nasal wash aspirates taken from children hospitalized with LRI who are at high risk for severe disease.
- No study drug will be administered for this study.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Be premature (less than 36 weeks gestation) and less than or equal to 12 months of age, and/or
- Be less than or equal to 24 months of age with CHD (other than uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus) that is judged to be hemodynamically significant, and/or
- Be less than or equal to 24 months of age with CLD of prematurity (BPD) requiring medical intervention/management (i.e., supplemental oxygen, steroids, bronchodilators, or diuretics within the previous 6 months).
- Hospital admission diagnosis referable to an acute lower respiratory tract infection or cardio/respiratory illness with a presumed respiratory infection (e.g., bronchiolitis, bronchitis, or pneumonia or cardiac decompensation associated with respiratory infection); admission must occur between October 1 and June 30 for northern hemisphere sites, and between March 1 and November 30 for southern hemisphere sites.
- Study enrollment within 2 days after hospitalization.
Key exclusion criteria (1 listed)
- Known HIV infection or a mother with known HIV infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Risk Respiratory Disease | Behavioural | – |
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 7 May 2007.
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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.
Margarita Gomez, M.D. study director
MedImmune LLC
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Respiratory Disease, run by MedImmune LLC at 24 sites in 4 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 7 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 7 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada, Australia, Italy. 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 7 May 2007.