Adverse Drug Reaction monitoring in Patients receiving Anti Tubercular ( ATT ) and Antiretroviral Therapy ( ART )
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- 1.To study the frequency of adverse drug reactions in patients receiving anti-tubercular ( ATT ) and antiretroviral drugs ( ART ) every 4 to 6 weeks.
研究概览
简要总结
The study aims to evaluate the adverse drug reaction profile in patients receiving anti-tubercular therapy (ATT) and antiretroviral therapy (ART), focusing on the frequency, nature, and characteristics of these reactions. Conducted as an analytical-cross sectional type/prospective cohort study from Jan 2024 to Jan 2026 in the Departments of Pharmacology and TB & Chest from Jan 2024 to Dec 2025, the study will encompass 600 patients experiencing adverse drug reactions. The justification for this sample size is based on previous research findings. Inclusion criteria involve patients above 18 years with various forms of TB, while exclusion criteria include incomplete data, treatment defaulters, or alternate diagnoses post-treatment initiation. Methodology includes assessing ADR frequency, nature, severity, causality using standardized scales, concurrent medications, and comorbid conditions.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Cases of adverse drug reactions due to anti-tubercular and antiretroviral therapy.
- •2.Patients more than 18 years with Pulmonary TB, EPTB or disseminated TB.
排除标准
- •1.Cases having incompletely filled adverse drug reaction details will be excluded from the study.
- •2.Treatment defaulters or death within 15 days of ATT.
- •3.Any other diagnosis other than TB after starting treatment.
- •4.Cases who do not give consent.
结局指标
主要结局
1.To study the frequency of adverse drug reactions in patients receiving anti-tubercular ( ATT ) and antiretroviral drugs ( ART ) every 4 to 6 weeks.
时间窗: 18 months
2.To study the nature of adverse drug reactions in Patients receiving anti-tubercular ( ATT ) and antiretroviral drugs ( ART ) and to characterize ADR according to type , Severity and time of occurrence every 4 to 6 weeks
时间窗: 18 months
次要结局
- • To compare clinical and therapeutic details in serious and non serious cases of adverse drug reactions due to anti-tubercular and antiretroviral drugs.
研究者
Puneet Paliwal
Jawaharlal nehru medical college a.m.u