Guidelines for diagnosis, treatment and prevention of visceral leishmaniasis in South Sudan Acromyns DAT Direct agglutination test FDA Freeze – dried antigen IM Intramuscular IV Intravenous KA Kala–azar ME Mercaptoethanol ORS Oral rehydration salt PKDL Post kala–azar dermal leishmaniasis RBC Red blood cells RDT Rapid diagnostic test RR Respiratory rate SSG Sodium stibogluconate TFC Therapeutic feeding centre TOC Test of cure VL Visceral leishmaniasis WBC White blood cells WHO World Health Organization Table of contents Acronyms ...................................................................................................................................... 2 Acknowledgements ....................................................................................................................... 4 Foreword ...................................................................................................................................... 5 1. Introduction ........................................................................................................................... 7 1.1 Background information ............................................................................................... 7 1.2 Lifecycle and transmission patterns ............................................................................. 7 1.3 Human infection and disease ....................................................................................... 8 2. Diagnosis ............................................................................................................................... 9 2.1 Clinical diagnosis .......................................................................................................... 9 2.2 Laboratory diagnosis .................................................................................................. 10 2.3 Diagnosis of primary kala–azar .................................................................................. 13 2.4 Diagnosis of relapse ................................................................................................... 14 2.5 Diagnosis of PKDL ..................................................................................................... 14 3. Treatment ............................................................................................................................. 14 3.1 Treatment of primary kala–azar (new cases) ............................................................. 16 3.2. Treatment of relapse of kala–azar .............................................................................. 18 3.3. Treatment of PKDL ..................................................................................................... 20 3.4. Other treatment related issues and special situations ............................................... 21 3.5 Treatment of concurrent infection and malnutrition .................................................... 23 4. Information system ............................................................................................................. 33 5. Prevention and control ....................................................................................................... 33 6. Annexes................................................................................................................................ 34 Annex 1. rK39 rapid diagnostic test procedure ...................................................................... 34 Annex 2. Direct agglutination test procedure ......................................................................... 38 Annex 3. Lymph node aspirate procedure ............................................................................. 44 Annex 4. Bone marrow aspiration procedures ...................................................................... 45 Annex 5. Procedures for splenic aspiration ........................................................................... 47 Annex 6. Preparation and examination of aspirates. grading of parasites. ........................... 49 Annex 7. Kala–azar laboratory register book ........................................................................ 53 Annex 8. Kala–azar treatment register book ......................................................................... 54 Annex 9. Kala–azar patient treatment card ........................................................................... 56 Annex 10. Kala–azar patient discharge card ......................................................................... 58 Annex 11. Dosage and precautions for the use of sodium stibogluconate (SSG) ............. 59 Annex 12. Dosage and precautions for the use of paromomycin (aminosidine). .................. 62 Annex 13. Dosage, administration and precautions for meglumine antimoniate. ................. 64 Annex 14. Anthropometry and nutrition therapy look–up tables. ........................................... 66 Annex 15. Overview of treatment for concurrent illnesses in kala–azar. ............................... 75 Annex 16. Medicine guidelines for kala–azar ........................................................................ 77 Annex 17. Kala–azar monthly reporting forms ...................................................................... 78 Annex 18. Kala–azar weekly reporting forms ........................................................................ 82 Guidelines for diagnosis, treatment and prevention of visceral leishmaniasis in South Sudan Acknowledgements The Visceral Leishmaniasis (VL) guideline for South Sudan has been updated through a highly participatory process involving officials from endemic kala-azar states, World Health Organization representatives from Geneva-HQ, Cairo-EMRO, Sudan, Ethiopia, Somalia, UNICEF South Sudan, UN-OCHA, international (MSF’s, CMA, DoT) and national partners. I sincerely appreciate and commend the role of the World Health Organization in supporting the Ministry of Health financially, technically and logistically; without which this document would have not been materialized. I would like to thank health workers in twenty four kala-azar treatment facilities; in particular nurses, laboratory technicians and community health workers. Without their continuous daily efforts in diagnosing, treating and monitoring patients, no progress on kala-azar guidelines would have been possible. A special thank you is extended to Dr Jose Postigo for valuable comments, guidance and effective assistance during the guidelines preparation and printing process. The guidance provided in this document has been drawn from vast experience and lessons learnt from global, regional and local level. We hope the guideline will unify kala-azar management in endemic foci and will be able to significantly reduce the high burden of kala-azar in the endemic states. Dr. Lul Riek, Director General for Community and Public Health, Ministry of Health, South Sudan-Juba 4 Guidelines for diagnosis, treatment and prevention of visceral leishmaniasis in South Sudan Foreword Visceral Leishmaniasis (VL) is the third most important vector-borne disease after malaria and lymphatic filariasis. It was responsible for an estimated 10,000 new cases in 2010, and a 4% case fatality rate in twenty four kala-azar treatment facilities in Jonglei, Upper Nile, Unity and Eastern Equatoria States of South Sudan. Efficient case management is the key to limit morbidity and to prevent mortality, and is also a measure to control the reservoir and transmission of the disease. South Sudan has upgraded from a first line regime of mono-therapy, sodium stibogluconate (SSG) for 30 days, to combination therapy of sodium stibogluconate (SSG) and paromomycin injections for 17 days; this is more effective than SSG monotherapy. In addition it offers the advantage of halving the patient’s required hospital stay, thus reducing overcrowding and the risk of nosocomial outbreaks of infectious diseases associated with overcrowding. Based on the guidelines, the WHO South Sudan office is willing to support the National Ministry of Health in providing training on VL diagnosis, treatment and prevention to the health workers in the twenty four kala-azar treatment facilities. The guidance provided in this document has been drawn upon vast experience and lessons learnt from global, regional, government, and national partners. It is the Ministry’s hope that the document will be a source of renewed motivation for a more unified, directional and concerted effort in further improving the diagnosis and management of kala-azar patients. Let us now, and in years ahead, join our efforts and ensure that the plan translates into concrete, focused and sustained actions. We hope this document will guide the Ministry’s efforts towards controlling kala-azar in South Sudan. We are looking forward to the cooperation and harmonization of the treatment regime in South Sudan. Dr. Makur Mathur Koriom, Undersecretary, Ministry of Health, South Sudan-Juba. 5 1. Introduction 1.1 Background information Leishmaniases is caused by over 20 species of parasitic protozoa of the genus Leishmania. The disease, transmitted to humans by sandflies (Phlebotomus and Lutzomyia species), is endemic in 98 countries or territories, affecting around two million people each year. Depending on the species of the parasite and the immune response of the host, the disease spectrum of leishmaniasis ranges from self–healing skin lesions to a fatal systemic disease called visceral leishmaniasis (VL) which is also known as kala–azar (KA), a Hindi term