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The design and development of a multicentric protocol to investigate the impact of adjunctive doxycycline on the management of peripheral lymphoedema caused by lymphatic filariasis and podoconiosis.
Horton, John; Klarmann-Schulz, Ute; Stephens, Mariana; Budge, Philip J; Coulibaly, Yaya; Debrah, Alex; Debrah, Linda Batsa; Krishnasastry, Suma; Mwingira, Upendo; Ngenya, Abdallah; Wanji, Samuel; Weerasooriya, Mirani; Yahathugoda, Channa; Kroidl, Inge; Deathe, Drew; Majewski, Andrew; Sullivan, Sarah; Mackenzie, Charles; Nutman, Thomas B; Shott, Joseph P; Weil, Gary; Ottesen, Eric; Hoerauf, Achim.
Affiliation
  • Horton J; Tropical Projects, 24 The Paddock, Hitchin, UK. hedgepigs@aol.com.
  • Klarmann-Schulz U; Institute for Medical Microbiology, Immunology and Parasitology (IMMIP), German Centre for Infection Research (DZIF), Bonn-Cologne Site, University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany.
  • Stephens M; Neglected Tropical Diseases Support Center, Task Force for Global Health, Decatur, GA, USA.
  • Budge PJ; Washington University School of Medicine, St. Louis, MO, USA.
  • Coulibaly Y; Filariasis Research Unit, International Center for Excellence in Research, ICER-Mali, Bamako, Mali.
  • Debrah A; Faculty of Allied Health Sciences, Kwame Nkrumah University of Science and Technology (KNUST), Kumasi, Ghana.
  • Debrah LB; Department of Microbiology, Kwame Nkrumah University of Science and Technology (KNUST), Kumasi, Ghana.
  • Krishnasastry S; Filariasis Research Unit, Govt. T D Medical College, Kerala, 699005, India.
  • Mwingira U; National Institute for Medical Research, Dar es Salaam, Tanzania.
  • Ngenya A; National Institute for Medical Research, Dar es Salaam, Tanzania.
  • Wanji S; Department of Microbiology and Parasitology, University of Buea, Buea, SW State, Cameroon.
  • Weerasooriya M; Filariasis Research Training and Services Unit (FRTSU), Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka.
  • Yahathugoda C; Filariasis Research Training and Services Unit (FRTSU), Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka.
  • Kroidl I; Division of Infectious Diseases and Tropical Medicine, University Hospital of the University of Munich (LMU), Munich, Germany.
  • Deathe D; Neglected Tropical Diseases Support Center, Task Force for Global Health, Decatur, GA, USA.
  • Majewski A; Neglected Tropical Diseases Support Center, Task Force for Global Health, Decatur, GA, USA.
  • Sullivan S; Neglected Tropical Diseases Support Center, Task Force for Global Health, Decatur, GA, USA.
  • Mackenzie C; Neglected Tropical Diseases Support Center, Task Force for Global Health, Decatur, GA, USA.
  • Nutman TB; Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20892, USA.
  • Shott JP; Division of Neglected Tropical Diseases, US Agency for International Development, 1300 Pennsylvania Ave NW, Washington, DC, USA.
  • Weil G; Washington University School of Medicine, St. Louis, MO, USA.
  • Ottesen E; Neglected Tropical Diseases Support Center, Task Force for Global Health, Decatur, GA, USA.
  • Hoerauf A; Institute for Medical Microbiology, Immunology and Parasitology (IMMIP), German Centre for Infection Research (DZIF), Bonn-Cologne Site, University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany.
Parasit Vectors ; 13(1): 155, 2020 Mar 30.
Article de En | MEDLINE | ID: mdl-32228663
ABSTRACT

BACKGROUND:

As new lymphatic filariasis infections are eliminated through mass chemotherapy, previously affected individuals are left with the sequellae, especially chronic progressive lymphoedema. Currently this is managed by careful attention to limb hygiene to prevent infection. Studies over the past 15 years have suggested that the incorporation of doxycycline treatment may arrest or even reverse progression of lymphoedema. Most of this work has been observational or based on small studies, and if this intervention is effective, studies need to be conducted on a larger scale and under diverse geographical and social conditions before it can be incorporated into treatment policy. METHODS/

DESIGN:

The double-blind, placebo-controlled study was designed to investigate the impact of six weeks treatment with doxycycline added to standard limb hygiene on early stage filarial lymphoedema in five sites in Africa and the Indian subcontinent. One site in Cameroon is selected for studying lymphoedema in podoconiosis. Each site was individually powered with the potential to undertake a meta-analysis on completion. Evaluation methods followed those used in Ghana in 2012 with additions resulting from advances in technology. The details of the core protocol and how it was varied to take account of differing situations at each of the sites are provided. The study will enrol up to 1800 patients and will complete in mid-2021.

CONCLUSIONS:

This paper provides details of what challenges were faced during its development and discusses the issues and how they were resolved. In particular, the reasons for inclusion of new technology and the problems encountered with the supply of drugs for the studies are described in detail. By making these details available, it is hoped that the study protocol will help others interested in improving treatment for filarial lymphoedema in the design of future studies. Trial registration India Clintrials.gov. NCT02929121 registered 10 Oct 2016 https//clinicaltrials.gov/ct2/show/NCT02929121 Mali Clintrials.gov. NCT02927496 registered 7 Oct 2016 https//clinicaltrials.gov/ct2/show/NCT0292749 Sri Lanka Clintrials.gov. NCT02929134 registered 10 Oct 2016 https//clinicaltrials.gov/ct2/show/NCT02929134 Ghana ISRCTN. 14042737 registered 10 July 2017 https//doi.org/10.1186/ISRCTN14042737 Tanzania ISRCTN. 65756724 registered 21 July 2017 https//doi.org/10.1186/ISRCTN65756724 Cameroon ISRCTN. 1181662 registered 25 July 2017 https//doi.org/10.1186/ISRCTN11881662.
Sujet(s)
Mots clés

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Filariose lymphatique / Doxycycline / Éléphantiasis / Lymphoedème Type d'étude: Clinical_trials / Guideline / Systematic_reviews Limites: Humans Pays/Région comme sujet: Africa / Asia Langue: En Journal: Parasit Vectors Année: 2020 Type de document: Article Pays d'affiliation: Royaume-Uni

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Filariose lymphatique / Doxycycline / Éléphantiasis / Lymphoedème Type d'étude: Clinical_trials / Guideline / Systematic_reviews Limites: Humans Pays/Région comme sujet: Africa / Asia Langue: En Journal: Parasit Vectors Année: 2020 Type de document: Article Pays d'affiliation: Royaume-Uni