NCT01107535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2007

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 23, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

3.4 years

First QC Date

February 20, 2010

Results QC Date

February 7, 2012

Last Update Submit

October 26, 2012

Conditions

Respiratory Syncytial Virus Infection

Keywords

Synagis (palivizumab) immunoprophylaxisRespiratory syncytial virus infectionPreterm infants

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (4)

  • Number of Hospital Admission Days (All Causes)

    Hospital admission to hospital discharge

  • Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection

    Hospital admission to hospital discharge

  • Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission

    Hospital admission to hospital discharge

  • Number of Serious Adverse Events

    Enrollment until 100 days after the last Synagis (palivizumab) dose

Study Arms (1)

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.

Interventions

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.

Also known as: palivizumab, Synagis
Infants receiving Synagis (palivizumab) immunoprophylaxis

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Site Reference ID/Investigator# 27834

Arequipa, Peru

Location

Site Reference ID/Investigator# 6059

Callao, 2, Peru

Location

Site Reference ID/Investigator# 27836

Lima, 01, Peru

Location

Site Reference ID/Investigator# 27835

Lima, 27, Peru

Location

Related Links

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

PalivizumabAntibodies, Monoclonal

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Global Medical Services
Organization
Abbott
1-800-633-9110

Study Officials

  • Oscar Guerra, MD

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2010

First Posted

April 21, 2010

Study Start

September 1, 2007

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

October 31, 2012

Results First Posted

April 23, 2012

Record last verified: 2012-10

Locations

PE(4)