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

• ClinicalTrials.gov Identifier: NCT01107535
• Recruitment Status: Completed
• First Posted: April 21, 2010
• Results First Posted: April 23, 2012
• Last Update Posted: October 31, 2012
• Sponsor: Abbott
• Information provided by (Responsible Party): Abbott

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Respiratory Syncytial Virus Infection	Biological: Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.

Study Design

• Study Type: Observational
• Actual Enrollment: 82 participants
• 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
• Study Start Date: September 2007
• Actual Primary Completion Date: February 2011
• Actual Study Completion Date: February 2011

Groups and Cohorts

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: palivizumab; Synagis

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Number of Hospital Admission Days (All Causes) [ Time Frame: Hospital admission to hospital discharge ]
   The mean (average) number days participants were hospitalized.
2. 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.
3. 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.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: up to 6 Months (Child)
• Sexes Eligible for Study: All
• 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

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:

Related Info 

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT01107535
• Other Study ID Numbers: PMOS-PERU 07-01
• First Posted: April 21, 2010
• Results First Posted: April 23, 2012
• Last Update Posted: October 31, 2012
• Last Verified: October 2012

Keywords provided by Abbott:

Synagis (palivizumab) immunoprophylaxis; Respiratory syncytial virus infection; Preterm infants

Additional relevant MeSH terms:

Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections; Disease Attributes; Pathologic Processes; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Palivizumab; Antibodies; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs; Antiviral Agents; Anti-Infective Agents