Respiratory Syncytial Virus Infection
Conditions
Keywords
palivizumab, lower respiratory tract infection, Respiratory syncytial virus, usage patterns
Brief summary
The study was designed to gather information regarding the use of palivizumab for the prophylaxis for respiratory syncytial virus (RSV) infection in high-risk infants in selected countries within Latin America.
Detailed description
RSV causes significant disease. There is a paucity of data from developing countries even though existing data clearly indicate that RSV accounts for a high proportion of acute respiratory illnesses (ARIs) in children. This is a multi-center study in a cohort of infants at risk for RSV infection in Latin America who have received palivizumab in the usual manner in accordance with the terms of marketing authorization with regard to dose, population and indication. Enrolled participants were followed for one year after their first dose of palivizumab. Epidemiological and clinical data as well as information about compliance, hospitalizations and safety was collected.
Interventions
None listed
Sponsors
Fundasamin (Argentina)
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
Inclusion criteria
* Children with a history of bronchopulmonary dysplasia, infants with a history of prematurity (less than or equal to 35 weeks gestational age), or children with hemodynamically significant congenital heart disease who received the first dose of palivizumab within the 2 weeks prior to the signature of the Informed Consent Form. * Parent or legal guardian of child provides written Informed Consent
Exclusion criteria
* Children excluded from receiving palivizumab as per local guidelines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | Baseline | Study participants were characterized at Baseline by history of bronchopulmonary dysplasia, history of prematurity (less than or equal to 35 weeks gestational age), children with hemodynamically significant congenital heart disease (CHD), the presence of cohabitants less than 6 years old, possible exposure to indoor tobacco smoke, day care attendance, asthmatic or atopic mother, smoking during pregnancy, breastfeeding, prenatal assistance (4 or more visits during pregnancy), neonatal hospitalization care, history of neonatal assisted ventilation, and mother education level (completed primary school). |
| Distribution of Comorbidities in Study Participants | Baseline | The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Factors for Hospitalization | Baseline and 12 months | Variables that could act as risk factors for hospitalization for lower respiratory tract infection were tested in univariate and multivariate Poisson regression models. Baseline characteristics, such as age, gender, birth weight and comorbidities were included as covariates in the Poisson regression model. Variables for multivariate analysis were added applying forward selection. Gestational age and birth weight were included as continuous variables, considering that the higher they were the better they could act as a protection factor for hospitalization due to respiratory infection. |
| Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV | 12 months | The number of participants with hospitalizations due to lower respiratory tract infection (LRTI) and hospitalizations due to lower respiratory tract infection caused by RSV. |
| Mean Number of Doses of Palivizumab Administered | 12 months | — |
| Compliance to Prescribed Palivizumab | 12 months | Compliance to prescribed palivizumab was calculated based on the number of doses received versus the expected number of doses for each participant. The expected number of doses for each participant was estimated based on seasonality and current prescription guidelines for each country. |
| Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV | 12 months | — |
Countries
Argentina, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Palivizumab Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization. | 458 |
| Total | 458 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Invalid Consent | 1 |
| Overall Study | Lost to Follow-up | 43 |
| Overall Study | No Study Visits | 4 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Received Palivizumab in Previous Season | 1 |
| Overall Study | Site Closure | 3 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Palivizumab |
|---|---|
| Age, Continuous | 55 days |
| Birth Weight | 1344.6 g STANDARD_DEVIATION 460.5 |
| Region of Enrollment Argentina | 149 participants |
| Region of Enrollment Chile | 32 participants |
| Region of Enrollment Colombia | 147 participants |
| Region of Enrollment Ecuador | 7 participants |
| Region of Enrollment Mexico | 100 participants |
| Region of Enrollment Peru | 13 participants |
| Region of Enrollment Uruguay | 10 participants |
| Sex: Female, Male Female | 219 Participants |
| Sex: Female, Male Male | 239 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 299 / 458 |
| serious Total, serious adverse events | 102 / 458 |
Outcome results
Primary
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Study participants were characterized at Baseline by history of bronchopulmonary dysplasia, history of prematurity (less than or equal to 35 weeks gestational age), children with hemodynamically significant congenital heart disease (CHD), the presence of cohabitants less than 6 years old, possible exposure to indoor tobacco smoke, day care attendance, asthmatic or atopic mother, smoking during pregnancy, breastfeeding, prenatal assistance (4 or more visits during pregnancy), neonatal hospitalization care, history of neonatal assisted ventilation, and mother education level (completed primary school).
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | History of bronchopulmonary dysplasia | 134 participants |
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | Prematurity | 449 participants |
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | Congenital heart disease | 46 participants |
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | Presence of cohabitants <6 years of age | 160 participants |
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | Smoking at home | 78 participants |
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | Day care attendance | 5 participants |
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | Asthmatic / atopic mother | 55 participants |
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | Smoking during pregnancy | 9 participants |
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | Breastfeeding | 336 participants |
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | Prenatal assistance | 386 participants |
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | Neonatal care hospitalization | 447 participants |
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | History of neonatal assisted ventilation | 257 participants |
| Palivizumab | Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection | Mother education level | 443 participants |
Primary
Distribution of Comorbidities in Study Participants
The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palivizumab | Distribution of Comorbidities in Study Participants | Prematurity only | 64.63 percentage of participants |
| Palivizumab | Distribution of Comorbidities in Study Participants | Bronchopulmonary dysplasia (BPD) only | 0.87 percentage of participants |
| Palivizumab | Distribution of Comorbidities in Study Participants | Congenital heart disease (CHD) only | 0.87 percentage of participants |
| Palivizumab | Distribution of Comorbidities in Study Participants | BPD + Prematurity | 24.45 percentage of participants |
| Palivizumab | Distribution of Comorbidities in Study Participants | Prematurity + CHD | 5.24 percentage of participants |
| Palivizumab | Distribution of Comorbidities in Study Participants | Prematurity + BPD + CHD | 3.71 percentage of participants |
| Palivizumab | Distribution of Comorbidities in Study Participants | BPD + CHD | 0.22 percentage of participants |
Secondary
Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV
Time frame: 12 months
Population: Participants with hospitalization due to LTRI and hospitalization due to LTRI and RSV.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palivizumab | Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV | Bronchopulmonary dysplasia | 32 hospitalization episodes |
| Palivizumab | Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV | Congenital heart disease | 7 hospitalization episodes |
| Palivizumab | Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV | Prematurity | 60 hospitalization episodes |
| LTRI Due to RSV | Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV | Prematurity | 12 hospitalization episodes |
| LTRI Due to RSV | Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV | Bronchopulmonary dysplasia | 9 hospitalization episodes |
| LTRI Due to RSV | Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV | Congenital heart disease | 1 hospitalization episodes |
Secondary
Compliance to Prescribed Palivizumab
Compliance to prescribed palivizumab was calculated based on the number of doses received versus the expected number of doses for each participant. The expected number of doses for each participant was estimated based on seasonality and current prescription guidelines for each country.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palivizumab | Compliance to Prescribed Palivizumab | 83.66 Percentage of expected dose |
Secondary
Mean Number of Doses of Palivizumab Administered
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palivizumab | Mean Number of Doses of Palivizumab Administered | 3.8 doses | Standard Deviation 1.26 |
Secondary
Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV
The number of participants with hospitalizations due to lower respiratory tract infection (LRTI) and hospitalizations due to lower respiratory tract infection caused by RSV.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palivizumab | Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV | Hospitalization due to LRTI due to RSV | 12 participants |
| Palivizumab | Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV | Hospitalization due to LRTI | 52 participants |
Secondary
Risk Factors for Hospitalization
Variables that could act as risk factors for hospitalization for lower respiratory tract infection were tested in univariate and multivariate Poisson regression models. Baseline characteristics, such as age, gender, birth weight and comorbidities were included as covariates in the Poisson regression model. Variables for multivariate analysis were added applying forward selection. Gestational age and birth weight were included as continuous variables, considering that the higher they were the better they could act as a protection factor for hospitalization due to respiratory infection.
Time frame: Baseline and 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palivizumab | Risk Factors for Hospitalization | Sex (Female) | 0.919 rate ratio |
| Palivizumab | Risk Factors for Hospitalization | Gestational Age | 0.925 rate ratio |
| Palivizumab | Risk Factors for Hospitalization | Bronchopulmonar Dysplasia | 2.768 rate ratio |
| Palivizumab | Risk Factors for Hospitalization | Cardiopathy | 1.149 rate ratio |
| Palivizumab | Risk Factors for Hospitalization | Smoking | 2.546 rate ratio |
| Palivizumab | Risk Factors for Hospitalization | Birth Weight | 0.9996 rate ratio |
| Palivizumab | Risk Factors for Hospitalization | Compliance | 1.004 rate ratio |
| Palivizumab | Risk Factors for Hospitalization | Maternal Education (elementary) | 2.108 rate ratio |
| LTRI Due to RSV | Risk Factors for Hospitalization | Maternal Education (elementary) | 1.84 rate ratio |
| LTRI Due to RSV | Risk Factors for Hospitalization | Sex (Female) | 0.925 rate ratio |
| LTRI Due to RSV | Risk Factors for Hospitalization | Smoking | 1.36 rate ratio |
| LTRI Due to RSV | Risk Factors for Hospitalization | Gestational Age | 1.022 rate ratio |
| LTRI Due to RSV | Risk Factors for Hospitalization | Compliance | 1.005 rate ratio |
| LTRI Due to RSV | Risk Factors for Hospitalization | Bronchopulmonar Dysplasia | 2.754 rate ratio |
| LTRI Due to RSV | Risk Factors for Hospitalization | Birth Weight | 0.9998 rate ratio |
| LTRI Due to RSV | Risk Factors for Hospitalization | Cardiopathy | 0.925 rate ratio |