Respiratory Syncytial Virus InfectionNCT01297504
A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America
An observational study of Respiratory Syncytial Virus Infection, run by AbbVie (prior sponsor, Abbott) at 24 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Respiratory Syncytial Virus Infection
- How many people
- 464 participants
- Where
- 24 sitesin 7 countries
- Study dates
- Feb 2011to Aug 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: The study was conducted at primary care clinics in Latin America.
Who may be able to join
- 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
Who cannot join
- Children excluded from receiving palivizumab as per local guidelines
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
Colombia10 sites
Site Reference ID/Investigator# 52732
Armenia
Site Reference ID/Investigator# 52722
Barranquilla
Site Reference ID/Investigator# 52726
Barranquilla
Site Reference ID/Investigator# 52723
Bogotá
Site Reference ID/Investigator# 52725
Bogotá
Site Reference ID/Investigator# 52727
Bogotá
Site Reference ID/Investigator# 52729
Bogotá
Site Reference ID/Investigator# 63882
Bogotá
Site Reference ID/Investigator# 52735
Cali
Site Reference ID/Investigator# 52731
Medellín
Argentina4 sites
Site Reference ID/Investigator# 52185
Buenos Aires, C1115AAB
Site Reference ID/Investigator# 52182
Buenos Aires
Site Reference ID/Investigator# 52183
Buenos Aires
Site Reference ID/Investigator# 52184
Buenos Aires
Mexico3 sites
Site Reference ID/Investigator# 52082
Guanajuato, Leon, CP 03700
Site Reference ID/Investigator# 52084
Mexico City, DF, CP 04530
Site Reference ID/Investigator# 52083
Nuevo Leon, Monterrey, CP 66480
Chile2 sites
Site Reference ID/Investigator# 54426
Santiago
Site Reference ID/Investigator# 54427
Santiago
Ecuador2 sites
Site Reference ID/Investigator# 52703
Quito
Site Reference ID/Investigator# 52704
Quito
Peru2 sites
Site Reference ID/Investigator# 52243
Callao, CALLAO 2
Site Reference ID/Investigator# 52242
Lima, 33
About this study
Official title: A One-Year Observational Study of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America
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.
Read the 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.
- Conditions
- Respiratory Syncytial Virus Infection
- Keywords
- palivizumab, lower respiratory tract infection, Respiratory syncytial virus, usage patterns
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Palivizumab | Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Distribution of Comorbidities in Study Participants
The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.
Measured: Baseline
Secondary outcomes (5)
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.
Measured: 12 months
Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV
Measured: 12 months
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.
Measured: Baseline and 12 months
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.
Measured: 12 months
Mean Number of Doses of Palivizumab Administered
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundasamin (Argentina)
- Responsible party
- Sponsor
- Investigators
- Leandro Castillo, MD, Study director, Abbvie S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297504
- Sponsor's protocol ID
- P10-129
- Status last verified
- Sep 2014
- First submitted
- 15 Feb 2011
- Last updated
- 1 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One-Year Observational Study of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America
- ClinicalTrials.gov ID
- NCT01297504
- Acronym / sponsor ID
- P10-129
- Conditions
- Respiratory Syncytial Virus Infection
- Keywords
- palivizumab, lower respiratory tract infection, Respiratory syncytial virus, usage patterns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Fundasamin (Argentina)
- Study start
- Feb 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Posted 3 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palivizumab | – | –Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study was conducted at primary care clinics in Latin America.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Children excluded from receiving palivizumab as per local guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Time frame: 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
Time frame: Baseline
The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.
5 secondary outcomes
Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV
Time frame: 12 months
Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV
Time frame: 12 months
Risk Factors for Hospitalization
Time frame: Baseline and 12 months
Compliance to Prescribed Palivizumab
Time frame: 12 months
Mean Number of Doses of Palivizumab Administered
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leandro Castillo, MD study director
Abbvie S.A.
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infection, run by AbbVie (prior sponsor, Abbott) at 24 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Colombia, Argentina, Mexico, Chile, Ecuador and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.