Respiratory Syncytial Virus Infection
Conditions
Keywords
Synagis (palivizumab) immunoprophylaxis, Respiratory syncytial virus infection, Preterm infants
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.
Interventions
BIOLOGICALSynagis (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.
Sponsors
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hospital Admissions by Respiratory Syncytial Virus Infection | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Hospital Admission Days (All Causes) | Hospital admission to hospital discharge | The mean (average) number days participants were hospitalized. |
| Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection | 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. |
| Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission | 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. |
| Number of Serious Adverse Events | 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. |
Countries
Peru
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 82 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
Baseline characteristics
| Characteristic | Infants Receiving Synagis (Palivizumab) Immunoprophylaxis |
|---|---|
| Age Continuous | 68 days STANDARD_DEVIATION 63 |
| Gestational age Gestational age >28 weeks and <32 weeks | 60 participants |
| Gestational age Gestational age less than 28 weeks | 22 participants |
| Region of Enrollment Peru | 82 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 82 |
| serious Total, serious adverse events | 11 / 82 |
Outcome results
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.
Time frame: First year of life (up to 12 months)
Population: Analysis included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infants Receiving Synagis (Palivizumab) Immunoprophylaxis | Number of Hospital Admissions by Respiratory Syncytial Virus Infection | 2 participants |
Secondary
Number of Hospital Admission Days (All Causes)
The mean (average) number days participants were hospitalized.
Time frame: Hospital admission to hospital discharge
Population: Analysis included all participants who were hospitalized during the study. This includes 2 participants hospitalized due to respiratory syncytial virus infection and 8 participants hospitalized for other respiratory diseases.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants Receiving Synagis (Palivizumab) Immunoprophylaxis | Number of Hospital Admission Days (All Causes) | 18.4 days | Standard Deviation 29.7 |
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.
Time frame: Hospital admission to hospital discharge
Population: Two participants with a total of 3 intensive care unit stays were analyzed. One participant was negative for respiratory syncytial virus during their first stay in the intensive care unit and was positive for respiratory syncytial virus at their second stay.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants Receiving Synagis (Palivizumab) Immunoprophylaxis | Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection | ICU stay length (n=1, RSV negative) | 5 days |
| Infants Receiving Synagis (Palivizumab) Immunoprophylaxis | Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection | ICU stay length (n=1, Stay #1 of 2, RSV negative) | 10 days |
| Infants Receiving Synagis (Palivizumab) Immunoprophylaxis | Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection | ICU stay length (n=1, Stay #2 of 2, RSV positive) | 106 days |
Secondary
Number of Serious Adverse Events
The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.
Time frame: Enrollment until 100 days after the last Synagis (palivizumab) dose
Population: Analysis included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infants Receiving Synagis (Palivizumab) Immunoprophylaxis | Number of Serious Adverse Events | 11 participants |
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.
Time frame: Hospital admission to hospital discharge
Population: Analysis of supplemental oxygen included participants with any hospital stay during the study (n=10) and analysis of mechanical ventilation included the subgroup of participants with intensive care unit stays during the study (n=2).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infants Receiving Synagis (Palivizumab) Immunoprophylaxis | Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission | Supplemental oxygen (n=10) | 17 days | Standard Deviation 32 |
| Infants Receiving Synagis (Palivizumab) Immunoprophylaxis | Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission | Mechanical ventilation (n=2) | 36.7 days | Standard Deviation 49 |