03.10.2024

Clinical Trials to Assess Effectiveness of Treatment Guidelines for Lymphedema Induced by Lymphatic Filariasis

The TAKeOFF Consortium together with other LeDoxy trial centres have published their joint study on Lymphedema management using hygiene measures and doxycycline administration. The multi-centre, multi-country clinical trial, was conducted in 5 country, Ghana, Tanzania, Mali, Sri Lanka and India.  The trials were a collaborative effort between COR-NTD (TaskForce for Global Health, Atlanta, USA) and IMMIP (Institute of Medical Microbiology, Immunology and Parasitology, The German Center for Infection Research, Bonn-Cologne site, Germany). Trials in Ghana and Tanzania were funded by The German Federal Ministry of Education and Research (BMBF), and United States Agency for International Development (USAID) through its Neglected Tropical Diseases Program through their support of the Coalition for Operational Research on Neglected Tropical Diseases (COR-NTD) grant (AID-OAA-G-14-00008), funded those conducted in Mali, Sri Lanka and India.

 The TAKeOFF consortium is funded by BMBF under the RHISSA program and is in its second funding period. The consortium coordinated by both Prof. Alexander Debrah, KCCR and KNUST, Kumasi Ghana and Prof. Achim Hoerauf, has 4 principal investigators; Prof. Samuel Wanji, from University of Buea Cameroon, Dr. Linda Batsa Debrah KCCR & KNUST Kumasi Ghana, Dr. Ute Klarmann-Schulz, University Hospital Bonn and Dr. Akili Kalinga, NIMR Tanzania.
The trials had a combination of more than 1400 patients with lymphedema who were managed and monitored intensively for two years. Our TAKeOFF trial centers in Ghana and Tanzania had 420 patients per site. Using the primary endpoint after 2 years to assess the lymphedema and score them as “improved”, “not improved” or “worsened”, this biggest clinical trial ever conducted on LF patients showed that overall, there was 16-40% improvement in the stage and only a small number worsened. The patients also had overall all an improved quality of life and reduced incidences of the very painful episodes of adenolymphangitis attacks.
The LeDoxy clinical trials, the first ever biggest clinical study ever conducted on filarial lymphedema patients as a multi-country - multi-center, with diverse social economic backgrounds and rigorous scientific design (Horton J., Klarmann-Schulz U., et al. 2020  DOI: 10.1186/s13071-020-04024-2  ) provided very robust data, showing that the WHO EPC package decreases disease severity.
Basing on the positive results from this studies, the TAKeOFF consortium in its second round of funding will follow the cohorts from the first study planned in our Research Task 1.
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