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Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00127608
Recruitment Status : Completed
First Posted : August 8, 2005
Results First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment Phase
Varicella Procedure: Collection of clinical samples Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 7, 2005
Actual Primary Completion Date : July 13, 2006
Actual Study Completion Date : July 13, 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles

Arms and Interventions
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Arm Intervention/treatment
Experimental: Varicella Group
Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
 Procedure: Collection of clinical samples

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.


Outcome Measures
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Primary Outcome Measures :
  1. Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample [ Time Frame: At Visit 1 (Day 0) ]
    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

  2. Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample by Storage Condition (Dry, Liquid) [ Time Frame: At Visit 1 (Day 0) ]
    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.

  3. Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab) [ Time Frame: At Visit 1 (Day 0) ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127608


Locations
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Czechia
GSK Investigational Site
Praha 8, Czechia, 180 81
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00127608    
Other Study ID Numbers: 103815
First Posted: August 8, 2005    Key Record Dates
Results First Posted: February 4, 2019
Last Update Posted: February 4, 2019
Last Verified: August 2018
Additional relevant MeSH terms:
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Chickenpox
Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
 DNA Virus Infections
Virus Diseases
Infections