Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis (SUNRISE)
29 czerwca 2016 zaktualizowane przez: AbbVie
Prospective, Multi-Center, Observational Program to Assess RSV Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis in Routine Clinical Setting in the Russian Federation
This was a non-interventional, prospective, multi-center study with no control group designed to assess the effectiveness of palivizumab in a population of infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)).
Participants received immunoprophylaxis during the RSV season, defined as October 2014 through April 2015, in routine clinical settings throughout the Russian Federation.
Przegląd badań
Status
Zakończony
Szczegółowy opis
Participants received intramuscular injections of palivizumab according to physicians' prescription and the local label.
The local label recommended 1 month injection intervals between 5 sequential injections at a dose of 15 mg/kg.
Participants could have received from 3 to 5 monthly injections of palivizumab during the 2014 - 2015 RSV season and the duration of this study.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
359
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
Nie starszy niż 1 rok (Dziecko)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)) who received immunoprophylaxis during the RSV season defined as October 2014 through April 2015 in routine clinical settings in the Russian Federation.
Opis
Inclusion Criteria:
- Planned prescription of palivizumab for immunoprophylaxis during RSV season or participants for whom palivizumab was prescribed and who received the first dose of palivizumab no later than 60 days before enrollment in the study
Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:
- Infants born ≤35 weeks gestational age AND are ≤6 months of age at the onset of the RSV season;
- Infants ≤24 months of age AND with a diagnosis of BPD (defined as oxygen requirement at a corrected gestational age of 36 weeks);
- Infants ≤24 months of age with hemodynamically significant CHD, unoperated or partially corrected.
- Written authorization to use individual data signed by parents or child representative
Exclusion Criteria:
- Major congenital malformation aside from CHD
- Chronic pulmonary disease other than BPD
- Acute period of any infection
- Contraindication to palivizumab prescription according to local label
- Administration of a product possibly containing RSV-neutralizing antibody within 30 days prior to enrollment or current administration (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Kohorta
- Perspektywy czasowe: Spodziewany
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
Infants at high-risk of serious RSV illness
Infants who received immunoprophylaxis during the RSV season
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test
Ramy czasowe: Approximately 7 months
|
Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.
|
Approximately 7 months
|
|
Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection
Ramy czasowe: Approximately 7 months
|
Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.
|
Approximately 7 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test
Ramy czasowe: Approximately 7 months
|
The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented.
|
Approximately 7 months
|
|
Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants
Ramy czasowe: Approximately 7 months
|
The number of hospitalized participants admitted to the Intensive Care Unit was documented.
|
Approximately 7 months
|
|
Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)
Ramy czasowe: Approximately 7 months
|
The median length of stay of hospitalized participants in the Intensive Care Unit was calculated.
|
Approximately 7 months
|
|
Proportion of Participants Who Received Supplemental Oxygen While Hospitalized
Ramy czasowe: Approximately 7 months
|
The proportion of participants who received supplemental oxygen while hospitalized was documented.
|
Approximately 7 months
|
|
Proportion of Participants Who Received Mechanical Ventilation While Hospitalized
Ramy czasowe: Approximately 7 months
|
The proportion of participants who received mechanical ventilation while hospitalized was documented.
|
Approximately 7 months
|
|
Proportion of Participants With Missed Doses of Palivizumab
Ramy czasowe: Approximately 7 months
|
The proportion of participants with missed or delayed doses of palivizumab was documented.
|
Approximately 7 months
|
|
Proportion of Participants With Co-morbidities During Hospitalizations
Ramy czasowe: Approximately 7 months
|
The proportion of participants with co-morbidities during hospitalizations was documented.
Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).
|
Approximately 7 months
|
|
Median Duration of Mechanical Ventilation Administration During Hospitalizations
Ramy czasowe: Approximately 7 months
|
The median duration of mechanical ventilation administration during hospitalizations was calculated.
|
Approximately 7 months
|
|
Median Duration of Oxygen Administration During Hospitalizations
Ramy czasowe: Approximately 7 months
|
The median duration of mechanical oxygen administration during hospitalizations was calculated.
|
Approximately 7 months
|
|
Proportion of Participants With a Particular Co-morbidity
Ramy czasowe: Approximately 7 months
|
The proportion of participants with co-morbidities was documented.
Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).
|
Approximately 7 months
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: Andrey Strugovschikov, MD, AbbVie
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 października 2014
Zakończenie podstawowe (Rzeczywisty)
1 maja 2015
Ukończenie studiów (Rzeczywisty)
1 maja 2015
Daty rejestracji na studia
Pierwszy przesłany
3 listopada 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
3 listopada 2014
Pierwszy wysłany (Oszacować)
5 listopada 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
29 lipca 2016
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
29 czerwca 2016
Ostatnia weryfikacja
1 czerwca 2016
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- P14-579
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .