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Completed

NCT Number: NCT00127608

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

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.

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Key information

Conditions

Varicella Chickenpox DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

1 day–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site

Prague, 180 81, Czechia

About this study

The study involves NO therapeutic or prophylactic treatment nor further observation of the patients. There is no product to be tested in this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.

Treatment and study plan

Collection of clinical samples

Procedure

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 8, 2005
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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