Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection (INSPIRA)

October 26, 2012 updated by: Abbott

Observational Study of the Effectiveness of Synagis Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus Infection

Published data by the Organización panamericana de la Salud shows that Peru's mortality rate from acute respiratory infections (ARI) in infants less than one year of life is second only to Haiti (14,150/100,000). Government data reports shows a marked increase of RSV infections in Peru. "Instituto Nacional de Salud" (Peru's National Institute of Health) reports between January 1st to February 26th 2006, 62% of their positive samples corresponded to RSV. Epidemiological data from Lima-Peru, demonstrates that there is no specific season for RSV infection although some data suggest an increase in RSV activity during cold months (May to September; INS data). Clinical studies show that giving five doses of Synagis (palivizumab) resulted in serum concentrations > 30 ug/mL for >20 weeks. The aim of this post-marketing observational study is to determine the RSV hospitalization rate in high-risk infants who received Synagis (palivizumab) through the Social Security Hospitals in the context of routine clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Arequipa, Peru
        • Site Reference ID/Investigator# 27834
      • Callao, Peru, 2
        • Site Reference ID/Investigator# 6059
      • Lima, Peru, 01
        • Site Reference ID/Investigator# 27836
      • Lima, Peru, 27
        • Site Reference ID/Investigator# 27835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pre term neonates who received Synagis (palivizumab) according to the clinical practice. The study is implemented in 4 hospitals of Peru.

Description

Inclusion Criteria:

  • Receiving Synagis (palivizumab) immunoprophylaxis during respiratory syncytial virus season, according to the usual clinical practice:
  • Infants born < or = 32 weeks of gestation and are younger than 6 months of age at the beginning of the respiratory syncytial virus season.
  • Children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months, until the first year of life.
  • Children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment).

Exclusion Criteria:

  • Major congenital malformation aside from congenital heart disease
  • Chronic pulmonary disease other than bronchopulmonary dysplasia
  • Active infections
  • Contraindication to Synagis
  • Receipt of another immunoglobulin preparation including but not restricted to polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin (Cytogam), or respiratory syncytial virus hyperimmunoglobulin (Respigam).
  • Any other condition that according deemed an obstacle for study conduction or representing an unacceptable risk by the participating investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants receiving Synagis (palivizumab) immunoprophylaxis
Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
Biological: Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.
Synagis (palivizumab) administered according to usual clinical practice. After the enrollment visit, subjects will have monthly visits until they have received the complete Synagis immunization regimen of their hospital, then they will have 2 follow up visits, one of them 30 days after the fifth dose of Synagis and the other visit at one year of age.
Other Names:
  • Synagis
  • palivizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Hospital Admissions by Respiratory Syncytial Virus Infection
Time Frame: First year of life (up to 12 months)
The number of participants hospitalized for respiratory syncytial virus infection from the first dose of study drug up to the visit coinciding with the first birthday of the participant. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.
First year of life (up to 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Hospital Admission Days (All Causes)
Time Frame: Hospital admission to hospital discharge
The mean (average) number days participants were hospitalized.
Hospital admission to hospital discharge
Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection
Time Frame: Hospital admission to hospital discharge
The number of days spent in a hospital intensive care unit (ICU) are summarized for those participants requiring that type of care. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.
Hospital admission to hospital discharge
Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission
Time Frame: Hospital admission to hospital discharge
The mean (average) number of days participants required supplemental oxygen during any hospital stay and the mean number of days participants required mechanical ventilation while in the intensive care unit.
Hospital admission to hospital discharge
Number of Serious Adverse Events
Time Frame: Enrollment until 100 days after the last Synagis (palivizumab) dose
The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.
Enrollment until 100 days after the last Synagis (palivizumab) dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Oscar Guerra, MD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

February 20, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Estimate)

October 31, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMOS-PERU 07-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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