Back to resultsDetection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients
Primary Purpose
Varicella
Status
Completed
Phase
Phase 3
Locations
Czechia
Study Type
Interventional
Intervention
Collection of clinical samples
Sponsored by
About this trial
This is an interventional prevention trial for Varicella
Eligibility Criteria
Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Varicella Group
Arm Description
Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
Outcomes
Primary Outcome Measures
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
The estimated means of the viral load in log10 values for each storage condition (dry and liquid) and each type of sample are presented with 95% confidence intervals
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample by Storage Condition (Dry, Liquid)
The estimated viral load was calculated by quantitative polymerase chain reaction assay (Q-PCR) in log10, as a mean number of viral copies per sample by storage conditions (dry, liquid). As throat swabs were not stored dry and the number of crust samples was lower than that of papules and vesicles, this analysis was done only on data from vesicle fluid, vesicle swabs and papule swabs.
Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab)
The estimated viral load was calculated by quantitative polymerase chain reaction assay (Q-PCR) in log10, as a mean number of viral copies per sample by sample types (papule swab, vesicle fluid and vesicle swab).
As throat swabs were not stored dry and the number of crust samples was lower than that of papules and vesicles, this analysis was done only on data from vesicle fluid, vesicle swabs and papule swabs.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00127608
Brief Title
Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients
Official Title
An Open, Prospective, Non-prophylactic, Non Therapeutic Study for the Detection and Characterisation of Varicella Zoster Virus Collected From Dermal Lesions of Patients Who Are Diagnosed of Having Varicella/Breakthrough Varicella
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 7, 2005 (Actual)
Primary Completion Date
July 13, 2006 (Actual)
Study Completion Date
July 13, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study is conducted in order to collect clinical samples from patients who are diagnosed of having chickenpox infection. The results of this study will provide basic scientific information about chickenpox disease.
Detailed Description
The study involves NO therapeutic or prophylactic treatment nor further observation of the patients. There is no product to be tested in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Varicella Group
Arm Type
Experimental
Arm Description
Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
Intervention Type
Procedure
Intervention Name(s)
Collection of clinical samples
Intervention Description
The following samples were obtained from each subject:
Vesicle fluid (VF) and vesicle swabs (VS) from four vesicles (for a total of eight samples)
Papule swabs (PS) from four papules
Crusts from two lesions
One throat swab (TS) Up to 15 samples were to be obtained for each subject, when possible. VFs, VSs, PSs, and crusts were either stored dry or in liquid medium. TS samples were stored in liquid medium.
After extraction of DNA, samples were tested for the presence of varicella virus using a Quantitative Polymerase Chain Reaction (Q-PCR) technique.
Primary Outcome Measure Information:
Title
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
Description
The estimated means of the viral load in log10 values for each storage condition (dry and liquid) and each type of sample are presented with 95% confidence intervals
Time Frame
At Visit 1 (Day 0)
Title
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample by Storage Condition (Dry, Liquid)
Description
The estimated viral load was calculated by quantitative polymerase chain reaction assay (Q-PCR) in log10, as a mean number of viral copies per sample by storage conditions (dry, liquid). As throat swabs were not stored dry and the number of crust samples was lower than that of papules and vesicles, this analysis was done only on data from vesicle fluid, vesicle swabs and papule swabs.
Time Frame
At Visit 1 (Day 0)
Title
Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab)
Description
The estimated viral load was calculated by quantitative polymerase chain reaction assay (Q-PCR) in log10, as a mean number of viral copies per sample by sample types (papule swab, vesicle fluid and vesicle swab).
As throat swabs were not stored dry and the number of crust samples was lower than that of papules and vesicles, this analysis was done only on data from vesicle fluid, vesicle swabs and papule swabs.
Time Frame
At Visit 1 (Day 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
12. IPD Sharing Statement
Learn more about this trial
Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients
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