Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00127608 | Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients | PHASE3 | COMPLETED | 36 | — | — | Jun 7, 2005 | Jul 13, 2006 | Feb 4, 2019 | 1 | Czechia |
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
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.
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.
| Arm | Type | Description |
|---|---|---|
| Varicella Group | EXPERIMENTAL | Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease. |
| Name | Type | Description |
|---|---|---|
| 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. |
Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.