Somali Federal Government Ministry of Health Guidelines for diagnosis, treatment and prevention of visceral leishmaniasis in Somalia 2012 Contents Acronyms ...................................................................................................................... 4 Acknowledgements ............................................................................................................ 5 1. Introduction .............................................................................................................. 7 1.1 Background information ............................................................................................................. 7 1.2 Life-cycle and transmission patterns .......................................................................................... 8 1.3 Human infection and disease ..................................................................................................... 8 2. Diagnosis ................................................................................................................. 9 2.1 Clinical diagnosis ........................................................................................................................ 9 2.2 Laboratorydiagnosis ................................................................................................................. 10 2.3 Diagnosis of primary kala-azar ................................................................................................ 13 2.4 Diagnosis of relapse ................................................................................................................ 15 2.5 Diagnosis of PKDL ................................................................................................................... 15 3. Treatment .............................................................................................................. 15 3.1 Treatment of primary kala-azar (new cases) ........................................................................... 15 3.2 Treatment of relapse of kala-azar ............................................................................................ 18 3.3. Treatment of PKDL .................................................................................................................. 19 3.4 Other treatment related issues and special situations ............................................................ 20 3.5. Treatment of concurrent infection and malnutrition ................................................................. 22 4. Information system ................................................................................................... 32 5. Prevention and control .............................................................................................. 32 6. Annexes ................................................................................................................ 33 Annex 1. rK39 rapid diagnostic test procedure ....................................................................................... 33 Annex 3. Lymph node aspirate procedure ............................................................................. 42 Annex 4. Bone marrow aspiration procedures ........................................................................ 43 Annex 5. Procedures for splenic aspiration ............................................................................ 45 Annex 6. Preparation and examination of aspirates. Grading of parasites ..................................... 47 Annex 7. Kala-azar laboratory register book (left page) ............................................................ 51 Annex 8. Kala-azar treatment register book (left page) ............................................................. 53 Annex 9. Kala-azar patient treatment card (front) .................................................................... 55 Annex 10. Kala-azar patient discharge card ........................................................................... 57 Annex 11. Dosage and precautions for the use of sodium stibogluconate (SSG) ............................ 58 Annex 12. Dosage and precautions for the use of paromomycin (aminosidine). .................................... 60 Annex 13. Dosage, administration and precautions for meglumine antimoniate. .................................... 62 Annex 14. Anthropometry and nutrition therapy look-up tables. .............................................................. 64 Annex 15. Overview of treatment for concurrent illnesses in kala-azar. .................................................. 73 Annex 16. Drug guidelines for kala-azar .................................................................................................. 75 Annex 17. Kala-azar monthly reporting forms.......................................................................................... 76 Annex 18. Kala-azar weekly reporting forms .......................................................................... 81 Annex 19. Kala-azar line listing file (to be sent to central database on regular basis) ....................... 82 Acronyms DAT Direct agglutination test FDA Freeze – dried antigen IM Intramuscular IV Intravenous KA Kala-azar ME Mercapto-ethanol 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 Acknowledgements The Visceral Leishmaniasis (VL) guideline for Somalia has been updated through a highly participatory process involving officials from the Ministry of Health, Non-governmental Organizations supporting the various endemic kala-azar treatment centres, World Health Organization representatives from Somalia and EMRO, and national partners. I sincerely appreciate and commend the role of the World Health Organization in supporting the Ministry of Health technically and logistically without which this document would have not been materialized. I would like to thank health workers in kala-azar treatment facilities and the various INGOs supporting those facilities. I am fully cognizant that without their commitments and 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 Marthe Everard, WR for Somalia, for her support, to Dr José Postigo of WHO EMRO, and Dr Mohamed M Fuje and Godela von Döhren of WHO Somalia 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 standardize and unify kala-azar management in the endemic regions and will be able to significantly reduce the high burden of kala-azar in the endemic states. Mr. Duale Adam Mohamed Director General Ministry of Health, TFG Somalia Mogadishu 23rd July, 2012. Guidelines for diagnosis, treatment and prevention of visceral leishmaniasis in Somalia 1. Introduction 1.1 Background information Leishmaniases are 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 meaning ‘black fever’. Human leishmanial infections can result in 3 main forms of disease: Cutaneous leishmaniasis Muco-cutaneous leishmaniasis Visceral leishmaniasis (kala-azar) Visceral leishmaniasis (kala-azar) is a deadly disease caused by the protozoan Leishmania parasite, transmitted through the bite of Phlebotomus sandflies. The World Health Organization (WHO) estimates that globally about 500,000 new cases and over 50,000 deaths of kala-azar occur every year, over 90 % of these cases are from six countries: Bangladesh, Brazil, Ethiopia, India, Nepal and the Sudan. In Africa, there are five countries endemic for VL, namely Ethiopia, Kenya, Somalia, Uganda and the Sudan. Kala- azar generally affects poor and neglected populations living in remote rural areas. If not treated more than 95% of kala-azar cases will eventually die. Eastern Africa is one of the world’s main kala-azar endemic areas, with the majority of the burden being concentrated in focal areas in the east and south-east of Sudan. In Somalia, kala-azar is caused by Leishmania donovani. Phlebotomus martinii is the predominant vector in Somalia, but also P. vansomerenae was reported as possible vector (Trans R Soc Trop Med Hyg. 2003 Nov–Dec;97(6):667–71) . Man is believed to be the only reservoir and transmission is believed to be anthroponotic. Anecdotal cases were described as early as 1935, but VL was first officially reported in 1943, with the first outbreak reported in 1952 from Daarbuluk, Hargeisa. An endemic focus was described in 1965, with 12 cases diagnosed in Middle Shabele region, the majority of which occurred in young age groups and originated from the province capital Jowhar. Further VL cases were reported in 1995‐6 from the Lower Juba region by MSF‐B (Belgian Section) and a case was identified