Varicella-related Hospitalizations in Turkey (VARICOMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ener Cagri DINLEYICI, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT01887496
First received: November 12, 2012
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

Epidemiological information on varicella complications in children is essential for the development of appropriate immunization recommendations. Economic analyses of varicella immunization are sensitive to the costs of hospitalized cases, so there is a need to validate varicella-related hospitalization data in a country-specific manner. These data also provide a baseline for comparison with data collected 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 hospitalizations in Turkey is limited, center-specific and not sufficiently accurate. The aim of this multicenter study (VARICOMP) was to estimate the annual incidence of pediatric varicella-related hospitalization, describe the associated complications and estimate the annual mortality and economic cost of these cases.


Condition
Chickenpox

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Epidemiology and Economic Impact of Varicella Related Hospitalization in Turkey (VARICOMP Study)

Resource links provided by NLM:


Further study details as provided by Eskisehir Osmangazi University:

Primary Outcome Measures:
  • Annual incidence of varicella-related hospitalization [ Time Frame: Hospitalization rate between 2008-2013 (up to 5 years) ] [ Designated as safety issue: No ]
    The primary goal of this study was to estimate the annual incidence of hospitalization resulting from varicella and to describe the associated complications.


Secondary Outcome Measures:
  • The cost of varicella-related hospitalization in children. [ Time Frame: 2008-2013 (up to 5 years) ] [ Designated as safety issue: No ]

Enrollment: 1800
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chickenpox complications
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

0-18 years old hospitalized children due to varicella and -related complications

Criteria

Inclusion Criteria:

  • 0-18 years old hospitalized children due to varicella and -related complications
  • Previously healthy or with chronic disease or conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887496

Sponsors and Collaborators
Eskisehir Osmangazi University
Investigators
Principal Investigator: Ener C Dinleyici, MD Eskisehir Osmangazi University
  More Information

No publications provided

Responsible Party: Ener Cagri DINLEYICI, Associate Professor in Pediatrics, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier: NCT01887496     History of Changes
Other Study ID Numbers: VARICOMP
Study First Received: November 12, 2012
Last Updated: June 26, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Eskisehir Osmangazi University:
Varicella
Turkey
hospitalization
varicella vaccine

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 11, 2014