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Rate of severe cutaneous adverse reactions due to first line Anti-tuberculosis drugs, Health Product Vigilance Center database; Food and Drug Administration, Ministry of Public Health

Rate of severe cutaneous adverse reactions due to first line Anti-tuberculosis drugs, Health Product Vigilance Center database; Food and Drug Administration, Ministry of Public Health

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20180812003
Enrollment
3500
Registered
2018-08-12
Start date
2018-09-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe cutaneous adverse reactions SCARs cutaneous adversed reactions antituberculosis first line antituberculosis drugs SJS TEN DRESS AGEP severe cutaneous adverse reactions SCARs cutaneous adversed reactions antituberculosis first line antituberculosis drugs SJS TEN DRESS AGEP

Interventions

Adverse reaction report that were reported Stevens&#45
Johnson syndrome&#44
drug reactions with eosinophilia and systemic symptoms&#44
acute generalized exanthematous pustulosis and toxic epidermal necrolysis
Supportive Care
Report of patients occured SCARs

Sponsors

Tipsiri Chaikong
Lead Sponsor
Tipsiri Chaikong
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. reports that the culprit drugs was Isoniazid, Rifampin, Pyrazinamide, Ethambutol, Streptomycin 2. reports that adverse reactions was Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug reaction with eosinophilia and Systemic symptoms/ Drug-induced hypersensitivity syndrome (DRESS/ DIHS), Acute Generalized Exanthematous Pustulosis (AGEP) or the rash that was reported to be serious rash

Exclusion criteria

Exclusion criteria: The report that these data incompleted; report date, gender, age, drug allergy history, culprit drug name, start date, stop date, ADRs occurrence date, ADRs, causality relationship, seriousness of reactions, patient result from SCARs

Design outcomes

Primary

MeasureTime frame
rate of severe cutaneous adverse reaction 5 months Descriptive Statistics (frequency of severe cutaneous adverse reaction per 1000 patients by using PS

Secondary

MeasureTime frame
relationship between outcome and type of severe cutaneous adverse reactions 5 months chi square, logistic regression(95% confidence interval, odd ratios), Significant alpha 0.05

Countries

thailand

Contacts

Public ContactTipsiri Chaikong

Faculty of Pharmacy, Silpakorn University

chaikong_t@silpakorn.edu0896564287

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026