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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hospital Admission Days (All Causes) | The mean (average) number days participants were hospitalized. | Hospital admission to hospital discharge |
| Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection |
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Inclusion Criteria:
Exclusion Criteria:
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Pre term neonates who received Synagis (palivizumab) according to the clinical practice. The study is implemented in 4 hospitals of Peru.
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| Name | Affiliation | Role |
|---|---|---|
| Oscar Guerra, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 27834 | Arequipa | Peru | ||||
| Site Reference ID/Investigator# 6059 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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. |
| Hospital admission to hospital discharge |
| 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. | Hospital admission to hospital discharge |
| Number of Serious Adverse Events | The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section. | Enrollment until 100 days after the last Synagis (palivizumab) dose |
| Callao |
| 2 |
| Peru |
| Site Reference ID/Investigator# 27836 | Lima | 01 | Peru |
| Site Reference ID/Investigator# 27835 | Lima | 27 | Peru |
| Number of Participants Analyzed |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | The mean age of participants at the first injection of study drug. | Mean | Standard Deviation | days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Gestational age | Gestational age of participants. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis included all enrolled participants. | Posted | Number | participants | First year of life (up to 12 months) |
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| Secondary | Number of Hospital Admission Days (All Causes) | The mean (average) number days participants were hospitalized. | 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. | Posted | Mean | Standard Deviation | days | Hospital admission to hospital discharge |
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| 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. | 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. | Posted | Number | days | Hospital admission to hospital discharge |
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| 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. | 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). | Posted | Mean | Standard Deviation | days | Hospital admission to hospital discharge |
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| Secondary | Number of Serious Adverse Events | The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section. | Analysis included all enrolled participants. | Posted | Number | participants | Enrollment until 100 days after the last Synagis (palivizumab) dose |
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Adverse events were assessed throughout the study observation period until 100 days after the last dose of Synagis. Participants were followed for an average of 12.4 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 11 | 82 | 17 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Atelectasis neonatal | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory syncytial virus infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Retinopathy of immaturity | Eye disorders | Systematic Assessment |
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| Sudden infant death syndrome | General disorders | Systematic Assessment |
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| Intussusception | Gastrointestinal disorders | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bronchiolitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tracheobronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diarrhoea infectious | Infections and infestations | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069455 | Palivizumab |
| D000911 | Antibodies, Monoclonal |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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