Skip to main content
OpenTrials
Completed

NCT Number: NCT01107535

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Syncytial Virus Infection Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 27834, Arequipa, Peru

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.

Biological

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Acronym: INSPIRA

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 21, 2010
Registry last updated
Oct 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.