Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection (INSPIRA)
This study has been completed.
Sponsor:
Abbott
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01107535
First received: February 20, 2010
Last updated: October 26, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Respiratory Syncytial Virus Infection |
Biological: Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice. |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Observational Study of the Effectiveness of Synagis Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus Infection |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Number of Hospital Admissions by Respiratory Syncytial Virus Infection [ Time Frame: First year of life (up to 12 months) ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Number of Hospital Admission Days (All Causes) [ Time Frame: Hospital admission to hospital discharge ] [ Designated as safety issue: No ]The mean (average) number days participants were hospitalized.
- Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection [ Time Frame: Hospital admission to hospital discharge ] [ Designated as safety issue: No ]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.
- Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission [ Time Frame: Hospital admission to hospital discharge ] [ Designated as safety issue: No ]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.
- Number of Serious Adverse Events [ Time Frame: Enrollment until 100 days after the last Synagis (palivizumab) dose ] [ Designated as safety issue: Yes ]The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.
| Enrollment: | 82 |
| Study Start Date: | September 2007 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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:
|
Eligibility| Ages Eligible for Study: | up to 6 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107535
Locations
| Peru | |
| Site Reference ID/Investigator# 27834 | |
| Arequipa, Peru | |
| Site Reference ID/Investigator# 6059 | |
| Callao, Peru, 2 | |
| Site Reference ID/Investigator# 27836 | |
| Lima, Peru, 01 | |
| Site Reference ID/Investigator# 27835 | |
| Lima, Peru, 27 | |
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Oscar Guerra, MD | Abbott |
More Information
Additional Information:
No publications provided
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT01107535 History of Changes |
| Other Study ID Numbers: | PMOS-PERU 07-01 |
| Study First Received: | February 20, 2010 |
| Results First Received: | February 7, 2012 |
| Last Updated: | October 26, 2012 |
| Health Authority: | Peru: Ethics Committee |
Keywords provided by Abbott:
|
Synagis (palivizumab) immunoprophylaxis Respiratory syncytial virus infection Preterm infants |
Additional relevant MeSH terms:
|
Respiratory Syncytial Virus Infections Virus Diseases Pneumovirus Infections Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections Antibodies, Monoclonal |
Palivizumab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013