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

Respiratory Syncytial Virus Infection Clinical Trial

— INSPIRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107535
• Other study ID #: PMOS-PERU 07-01
• Status: Completed
• Phase: N/A
• First received: February 20, 2010
• Last updated: October 26, 2012
• Start date: September 2007
• Est. completion date: February 2011

Study information

• Verified date: October 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Syncytial Virus Infection
• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
Peru	Site Reference ID/Investigator# 27834	Arequipa
Peru	Site Reference ID/Investigator# 6059	Callao
Peru	Site Reference ID/Investigator# 27835	Lima
Peru	Site Reference ID/Investigator# 27836	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Hospital Admissions by Respiratory Syncytial Virus Infection	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)	No
Secondary	Number of Hospital Admission Days (All Causes)	The mean (average) number days participants were hospitalized.	Hospital admission to hospital discharge	No
Secondary	Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection	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	No
Secondary	Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission	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	No
Secondary	Number of Serious Adverse Events	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	Yes

External Links

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