Investigator(s)
| WHO Technical Officer |
Shahwar Kazmi WHO Country Office for India Shahwar Kazmi 
|
| Principal Investigator |
Niyamat Ali Siddiqui RMRIMS-(ICMR) Agamkuan, Patna, Bihar, India. Postal Code: 800007. Niyamat Ali Siddiqui
|
Title(s) and abstract
| Scientific title | Assessing magnitude of Visceral Leishmaniasis relapses and Post Kala-azar Dermal Leishmaniasis occurrence in Visceral Leishmaniasis treated Patients and their risks/predictors: a retrospective cohort study |
| Public title | Assessing magnitude of Visceral Leishmaniasis relapses and Post Kala-azar Dermal Leishmaniasis occurrence in Visceral Leishmaniasis treated Patients and their risks/predictors: a retrospective cohort study |
| Background | Visceral leishmaniasis (VL) is a public health threat for several tropical countries, including India. Primarily, VL is endemic in Bihar, manifesting periodically in major outbreaks. Provision of treatment during endemic periods and as an emergency response is impeded by instability and conflict. Therapy failures and relapses aggravate VL morbidity and mortality. Recently, India has achieved great success and has reached VL elimination threshold of 1 per 10,000 populations in 2023 and is maintaining the same for second consecutive year. The kala-azar elimination programme (KEP) under the India’s National Centre for Vector Borne Diseases Control (NCVBDC) focuses on both active and passive case detection of VL. The elimination phase of a disease programme can be the hardest: those cases that persist are often in the most difficult to treat, the disease burden shifts to those who are the most vulnerable and difficult to reach, and surveillance and control measures become harder to implement1. In addition, the price of success is often a reduction in financial and political support as competing disease priorities become louder. |
| Objectives | GENERAL OBJECTIVE General objective of the study is to assess the rate of VL relapse (recurrence) and its possible risks/predictors. SPECIFIC OBJECTIVES Specific objectives are to: 1. Determine rates of VL relapses (recurrences) 2. Quantify time period of VL relapses from initial VL treatment 3. Assess the risks/predictors(clinical and laboratory) of VL relapses (recurrences) 4. Assess the magnitude of VL re-infection 5. Determine the rate of PKDL occurrence following VL treatment |
| Study Methods | This retrospective cohort study will examine visceral leishmaniasis (VL) patients admitted to the indoor ward of RMRIMS in Patna from January 1, 2017, to December 31, 2023. The study will leverage comprehensive electronic and hard copy records, which include demographic, clinical, hematological, and biochemical data, ensuring standardized information is available from admission to discharge. Program data will not be utilized due to potential incompleteness. Inclusion criteria encompass all VL patients who were treated and cured, remained free of VL for more than 28 days after treatment, and attended follow-up visits for at least six months post-discharge. Conversely, exclusion criteria will involve patients who died, defaulted, were lost to follow-up, were transferred out, or had a positive parasitological test result indicating treatment failure. The study employs purposive sampling to select subjects from the pool of admitted patients, as a prospective cohort study is deemed impractical in this elimination-phase context. The sampling frame includes all admitted patients during the specified timeframe, with the sample size comprising those meeting eligibility criteria. This study, conducted over a planned 12-month duration from March to December 2025, aims to identify risk factors and predictors related to VL among the studied population, contributing valuable insights to address the disease. |
| Expected outcomes and use of results | Relapses and re-infection of VL aggravate VL morbidity and mortality, which is of great concern to the elimination programme at regional/global levels. The study may provide magnitude (rates) of VL relapses, re-infections and insight into the possible risks/predictors of VL relapses and its conversion into PKDL, and thus contributes to directing therapeutic options and patient follow-up. It will further quantify time period of VL relapse from initial VL treatment. Further, study will investigate the relationship of PKDL and VL relapses development to VL treatment among cured VL patients. Finally, study may provide evidence for policies to improve VL relapses and re-infections management in national program. |
| Keywords | Leishmaniasis, PKDL, Kala-Azar |
Research Details
| Student research | No |
| Start Date | 11-Mar-2025 |
| End Date | 15-Dec-2025 |
| Key Implementing Institution | Rajendra Memorial Research Institute of Medical Science (ICMR Regional Institute) |
| Multi-country research | No |
| Nationwide research | No |
| India | |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Infectious Disease |
| Involves human subjects | Yes |
| Operational Research | |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | No |