Clinical trial NCT01006629: Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
Official title: A Prospective, Multicenter, Open-label, Non-comparative Study of Safety and Efficacy of Synagis in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Respiratory Syncytial Virus Infection
Premature Birth
Bronchopulmonary Dysplasia
Congenital Heart Disease
Keywords: Efficacy of palivizumab
Respiratory syncytial virus (RSV) infection
Prevention of severe RSV infection
Preterm infants
Infants with bronchopulmonary dysplasia
Infants with hemodynamically significant congenital heart disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-11-03
Enrollment: 100
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the safety and efficacy of the drug in Russian subjects.

Detailed description: A prospective, multicenter, open-label, non-comparative study of safety and efficacy of palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe lower respiratory tract respiratory syncytial virus infection in 100 Russian children of 2 years of age and less in high-risk populations (preterm infants \[less than or equal to 35 weeks gestational age\], infants with bronchopulmonary dysplasia \[BPD\], and infants with hemodynamically significant congenital heart disease \[HSCHD\]).

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following criteria to be enrolled into the study:

1. Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:

   * Infants born at less than or equal to 35 weeks gestational age AND are less than or equal to 6 months of age at enrollment
   * Infants less than or equal to 24 months of age at enrollment AND with a diagnosis of bronchopulmonary dysplasia (defined as oxygen requirement at a corrected gestational age of 36 weeks) requiring intervention/management (i.e., oxygen, diuretics, bronchodilators, corticosteroids, etc.) anytime within 6 months prior to enrollment
   * Infants less than or equal to 24 months of age at enrollment with hemodynamically significant congenital heart disease, either cyanotic or acyanotic, unoperated or partially corrected. Children with acyanotic cardiac lesions must have pulmonary hypertension (greater than or equal to 40 mmHg measured pressure in the pulmonary artery \[ultrasound acceptable\]) or the need for daily medication to manage congenital heart disease. Children with the following conditions are not eligible: hemodynamically insignificant small atrial or ventricular septal defects, patent ductus arteriosis, children with aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone.
2. Informed Consent Form signed by parent(s).

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for the study:

1. Hospitalization at the time of enrollment (unless discharge is anticipated within 14 days).
2. Mechanical ventilation (including continuous positive airway pressure \[CPAP\]) at the time of enrollment.
3. Life expectancy less than 6 months.
4. Active respiratory illness, or other acute infection.
5. Known renal impairment, as determined by the investigator.
6. Known hepatic impairment, as determined by the investigator.
7. History of seizures (except neonatal seizures).
8. Unstable neurological disorder (includes, but is not restricted to, epilepsy and decompensated hydrocephaly).
9. Known immunodeficiency, as determined by the investigator.
10. Allergy to immunoglobulin products.
11. Prior receipt of RSV vaccine or prophylaxis (e.g., palivizumab or motavizumab), or administration of a product possibly containing RSV-neutralizing antibody within 100 days prior to enrollment (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin).
12. Participation in another clinical trial within 30 days prior to enrollment.
13. Previous enrollment in this trial.
14. For any reason, subject is considered by the investigator to be an unsuitable candidate for this study.

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: Through 30 days following the last injection of palivizumab
measure: Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV)
timeFrame: Through 30 days following the last injection of palivizumab
Secondary outcomes:
measure: Total Number of RSV Hospitalization Days
timeFrame: Through 30 days following the last injection of palivizumab
measure: Total RSV Hospitalization Days With Increased Supplemental Oxygen Requirement
timeFrame: Through 30 days following the last injection of palivizumab
measure: Number of Intensive Care Unit (ICU) Admissions During RSV Hospitalization
timeFrame: Through 30 days following the last injection of palivizumab
measure: Total Days of RSV ICU Stay
timeFrame: Through 30 days following the last injection of palivizumab
measure: Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization
timeFrame: Through 30 days following the last injection of palivizumab
measure: Total Days of Mechanical Ventilation During RSV Hospitalization
timeFrame: Through 30 days following the last injection of palivizumab
Other outcomes:
Locations:
city: Ivanovo
country: Russian Federation
facility: Site Ref # / Investigator 22699
city: Kazan
country: Russian Federation
facility: Site Ref # / Investigator 22694
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 24022
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 15744
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 15745
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 24025
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 15781
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 22686
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 15747
city: Novosibirsk
country: Russian Federation
facility: Site Ref # / Investigator 22696
city: Novosibirsk
country: Russian Federation
facility: Site Ref # / Investigator 24023
city: Saint Petersburg
country: Russian Federation
facility: Site Ref # / Investigator 22692
city: Saint Petersburg
country: Russian Federation
facility: Site Ref # / Investigator 22683
city: Saint Petersburg
country: Russian Federation
facility: Site Ref # / Investigator 22693
city: Saint Petersburg
country: Russian Federation
facility: Site Ref # / Investigator 22685
city: Saint Petersburg
country: Russian Federation
facility: Site Ref # / Investigator 15722
city: Saint Petersburg
country: Russian Federation
facility: Site Ref # / Investigator 15748
city: Saint Petersburg
country: Russian Federation
facility: Site Ref # / Investigator 15782
city: Tomsk
country: Russian Federation
facility: Site Ref # / Investigator 15746
Study officials:
affiliation: Abbott
name: Konstantin M Gudkov, MD
role: STUDY_DIRECTOR
References:
citation: Turti TV, Baibarina EN, Degtiareva EA, Keshishyan ES, Lobzin YV, Namazova-capital VE, Cyrillicaranova LS, Prodeus AP, Gudkov KM, Kruglova AI, Schulz GA, Notario GF. A prospective, open-label, non-comparative study of palivizumab prophylaxis in children at high risk of serious respiratory syncytial virus disease in the Russian Federation. BMC Res Notes. 2012 Sep 4;5:484. doi: 10.1186/1756-0500-5-484.