Investigator(s)
| WHO Technical Officer |
PRESHILA CHANDIMALI SAMARAWEERA WHO Country Office-Sri Lanka PRESHILA CHANDIMALI SAMARAWEERA 
|
| Principal Investigator |
Dilini Muthkumari Wijesekara Anti Leprosy Campaign, Ministry of Health Sri Lanka Dilini Muthkumari Wijesekara
|
Title(s) and abstract
| Scientific title | Adverse drug reactions for Multi Drug Therapy (MDT) among new Leprosy patients attending Dermatology/leprosy clinics in selected high endemic Districts in Sri Lanka |
| Public title | Adverse drug reactions for Multi Drug Therapy (MDT) among new Leprosy patients |
| Background | Sri Lanka has started MDT in 1983.The aim of introduction of MDT for leprosy was to prevent the development of drug resistance and to prevent relapses. Dapsone, Rifampicin and Clofazamine are the three first line drugs used to treat leprosy. While celebrating the successful journey towards elimination of leprosy as a public health problem globally in the year 2000, different parts of the world reported adverse drug reactions for MDT. |
| Objectives | General objective To describe the adverse drug reactions for Multi Drug Therapy and the association between Adverse Drug Reactions and sociodemographic and clinical characteristics among Leprosy patients attending dermatology/leprosy clinics in selected high endemic districts in Sri Lanka. Specific Objectives 1. To describe the ADRs for MDT among Leprosy patients attending Dermatology/ Leprosy clinics in selected high endemic districts in Sri Lanka. 2. To determine the association between selected sociodemographic characteristics and ADRs among Leprosy patients attending Dermatology/ Leprosy clinics in selected high endemic districts in Sri Lanka. 3. To determine the association between selected clinical characteristics and ADRs among Leprosy patients attending Dermatology/ Leprosy clinics in selected high endemic districts in Sri Lanka. 4. To describe the frequency of change of MDT regimes based on the development of ADRs among new Leprosy patients attending Dermatology/ Leprosy clinics in selected high endemic districts in Sri Lanka |
| Study Methods | All the new leprosy patients who will be starting on MDT will be included in the study with their consent. Considering that the study intends to assess the period prevalence of ADRs, the sample size will be calculated with the use of the following formula |
| Expected outcomes and use of results | All the adverse reactions will be reported adhering to the definitions for each of the adverse drug reactions. They will be individually verified with the respective consultant Dermatologist. Formal consenting procedure will be followed prior to data collection |
| Keywords | ADR, MDT, leprosy |
Research Details
| Student research | No |
| Start Date | 01-Sep-2024 |
| End Date | 31-Dec-2024 |
| Key Implementing Institution | Anti Leprosy Campaign |
| Multi-country research | No |
| Nationwide research | Yes, with randomly selected geographical areas |
| Sri Lanka | |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Infectious Disease |
| Involves human subjects | Yes |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | Final decision available |