Varicella-related Hospitalizations in Turkey (VARICOMP)
|ClinicalTrials.gov Identifier: NCT01887496|
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : July 28, 2017
|Condition or disease|
Varicella infection is one of the common childhood infectious disease. While usually self-limiting, a case of varicella can develop complications -sometimes potentially serious- requiring hospitalizations including secondary bacterial infections (mainly at the skin and skin structure), respiratory complications (pneumonia or exacerbation of asthma), neurological complications (encephalitis and cerebellitis). Most hospitalizations for varicella occurred in children who were previously healthy and can cause significant long term sequele and mortality in immunocompetent as well as immunocompromised children. Incidence of varicella and related hospitalization rates changes according to climates and also the presence of vaccination. WHO recommended that routine childhood varicella vaccination be considered in countries where the disease is a relatively important public health and socioeconomic problem however live attenuated varicella introduced to the childhood immunization programmes in Australia, Canada, Germany, Greece, Qatar, Republic of Korea, Saudi Arabia, Taiwan, United States, Uruguay, and parts of Italy and Spain. Clinically and statistically significant reduction in varicella-related hospitalizations for children and adults associated with childhood varicella immunization and a corresponding significant decrease in hospital charges.
Epidemiological information on varicella complications in children is essential to develop immunization recommendation strategies. Economic analyses of varicella immunization are sensitive to the costs of hospitalized cases, so there is a need to validate varicella related hospitalization data at the country-based level. The data also provide a baseline for the data after routine varicella immunization to evaluate the overall impact and cost-effectiveness of varicella immunization programs. Knowledge about the cause and incidence of varicella related hospitalization are limited and center-specific in Turkey and cannot provide sufficiently accurate information. Varicella infections have been commonly seen in children in Turkey and VZV seroprevalence increased with age and 70% at the age of 7 years and 90% in 15-19 years. Varicella vaccine is available in private practice in Turkey and estimated coverage is lower than 10%.
The aim of this multicenter study (VARICOMP study) to estimate the annual incidence of pediatric varicella related hospitalizations, describe the complications and estimate annual mortality and cost in children.
|Study Type :||Observational|
|Actual Enrollment :||1800 participants|
|Official Title:||The Epidemiology and Economic Impact of Varicella Related Hospitalization in Turkey (VARICOMP Study)|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Cases were identified by International Classification of Disease of the Tenth Revision (ICD-10) diagnostic codes for chickenpox infection or chickenpox-associated complications, if available.
- Annual incidence of varicella-related hospitalization [ Time Frame: Hospitalization rate between 2008-2013 (up to 5 years) ]The primary goal of this study was to estimate the annual incidence of hospitalization resulting from varicella and to describe the associated complications.
- The cost of varicella-related hospitalization in children. [ Time Frame: 2008-2013 (up to 5 years) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887496
|Principal Investigator:||Ener C Dinleyici, MD||Eskisehir Osmangazi University|