ChickenpoxVARICOMPNCT01887496
Varicella-related Hospitalizations in Turkey
An observational study of Chickenpox, run by Eskisehir Osmangazi University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Chickenpox
- How many people
- 1,800 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 0-18 years old hospitalized children due to varicella and -related complications
Who may be able to join
- 0-18 years old hospitalized children due to varicella and -related complications
- Previously healthy or with chronic disease or conditions
Who cannot join
None listed.
About this study
Official title: The Epidemiology and Economic Impact of Varicella Related Hospitalization in Turkey (VARICOMP Study)
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.
Read the 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.
- Conditions
- Chickenpox
- Keywords
- Varicella, Turkey, hospitalization, varicella vaccine
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual incidence of varicella-related hospitalization
The primary goal of this study was to estimate the annual incidence of hospitalization resulting from varicella and to describe the associated complications.
Measured: Hospitalization rate between 2008-2013 (up to 5 years)
Secondary outcomes (1)
The cost of varicella-related hospitalization in children.
Measured: 2008-2013 (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startSep 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChickenpoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ener Cagri DINLEYICI, Eskisehir Osmangazi University
- Investigators
- Ener C Dinleyici, MD, Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887496
- Sponsor's protocol ID
- VARICOMP
- Acronym
- VARICOMP
- Status last verified
- Jul 2017
- First submitted
- 12 Nov 2012
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiology and Economic Impact of Varicella Related Hospitalization in Turkey (VARICOMP Study)
- ClinicalTrials.gov ID
- NCT01887496
- Acronym / sponsor ID
- VARICOMP / VARICOMP
- Conditions
- Chickenpox
- Keywords
- Varicella, Turkey, hospitalization, varicella vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 0-18 years old hospitalized children due to varicella and -related complications
Key inclusion criteria (2 listed)
- 0-18 years old hospitalized children due to varicella and -related complications
- Previously healthy or with chronic disease or conditions
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
The cost of varicella-related hospitalization in children.
Time frame: 2008-2013 (up to 5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ener C Dinleyici, MD principal investigator
Eskisehir Osmangazi University
Questions about this trial
What is this clinical trial studying?
An observational study of Chickenpox, run by Eskisehir Osmangazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual incidence of varicella-related hospitalization (time frame: Hospitalization rate between 2008-2013 (up to 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.