Pan American Health Organization · Second edition, 2024 · 222 pages
Comprehensive operational manual for surveillance, diagnosis, treatment and vector/reservoir control of cutaneous, mucosal and visceral leishmaniasis for public-health professionals in endemic areas.
- Issuer
- Pan American Health Organization
- Edition
- Second edition, 2024
- Audience
- Public-health professionals, clinicians, epidemiologists, laboratory personnel, entomologists, veterinary public-health officers, health managers in leishmaniasis-endemic or at-risk areas
- Evidence
- Treatment recommendations: GRADE-rated systematic reviews (2022 PAHO Guidelines); surveillance/control procedures: expert consensus, regional operational experience, updated WHO 2010 technical report
- Reviewed
- 16 Oct 2026 · GMJ
What this guideline says
GMJ summary
This 222-page manual provides detailed standardized procedures for leishmaniasis surveillance and control across the Americas, covering all clinical forms (cutaneous, mucosal, visceral). It updates the 2019 first edition with new treatment recommendations based on 2022 GRADE-rated guidelines, revised epidemiological classifications for risk stratification, and comprehensive laboratory, entomological, and canine reservoir surveillance protocols.
The manual defines case definitions, diagnostic algorithms by level of care, treatment regimens by clinical type and Leishmania species, and epidemiological scenarios that determine surveillance intensity and control actions. For cutaneous leishmaniasis with L. braziliensis or L. panamensis, intralesional pentavalent antimonials (3–5 infiltrations of 1–5 ml, 3–7 day intervals) or miltefosine (2.5 mg/kg/day × 28 days, max 150 mg) are recommended. Mucosal leishmaniasis requires pentavalent antimonials 20 mg Sb⁺⁵/kg/day × 30 days. Visceral leishmaniasis should be treated with liposomal amphotericin B 3 mg/kg/day × 7 days (total 20 mg/kg).
Risk stratification divides areas into no transmission, low, moderate or intense transmission, each with specific surveillance actions: outbreak investigation, active case-finding, entomological surveys, canine census, and vector control. The manual emphasizes early diagnosis to reduce VL mortality and prevent CL/ML disfigurement, integration with laboratory networks, and One Health approaches linking human, veterinary and entomological surveillance.
Key points
For clinicians — doses and thresholds as stated in the guideline
- Cutaneous leishmaniasis (CL) localized lesions (1–3, ≤900 mm²): intralesional pentavalent antimonials 3–5 infiltrations of 1–5 ml per lesion at 3–7 day intervals (strong recommendation, low certainty), OR miltefosine 2.5 mg/kg/day × 28 days (max 150 mg/day) for adults with L. panamensis, L. mexicana, L. guyanensis, L. braziliensis (strong recommendation, low certainty).
- Mucosal/mucocutaneous leishmaniasis (ML/MCL): pentavalent antimonials 20 mg Sb⁺⁵/kg/day intravenous or intramuscular × 30 days ± pentoxifylline 400 mg every 8 hours × 30 days (strong recommendation, low/very low certainty); maximum daily dose 1215 mg Sb⁺⁵ or 3 ampoules.
- Visceral leishmaniasis (VL) in immunocompetent patients: liposomal amphotericin B 3 mg/kg/day intravenous × 7 days (total dose 20 mg/kg) (strong recommendation, low certainty); if unavailable, pentavalent antimonials 20 mg Sb⁺⁵/kg/day × 20 days or amphotericin B deoxycholate 1 mg/kg/day × 14–21 days (conditional recommendation, low certainty).
- VL in HIV-coinfected/immunocompromised: liposomal amphotericin B 3 mg/kg/day up to 20–40 mg/kg total dose (strong recommendation, very low certainty); secondary prophylaxis 3 mg/kg every 2–3 weeks if CD4 <350/mm³.
- Parasitological diagnosis CL: direct smear (scraping) from lesion margin at local/district level; sensitivity 78–90% depending on technique. ML/MCL requires biopsy/culture plus indirect immunofluorescence at reference centers.
- VL diagnosis: rK39 rapid immunochromatographic test at primary care level in endemic areas; bone marrow aspirate for direct examination (53–86% sensitivity) at secondary level; spleen aspirate (93–99% sensitivity) only with strict precautions for hemorrhage risk.
- Epidemiological stratification CL: areas classified as no transmission, low (<10 cases/year or <26/100,000), moderate (10–50 cases or 26–75/100,000), or intense (>50 cases or >75/100,000); each triggers specific surveillance and control actions including outbreak investigation, active case-finding, entomological surveys.
- Canine VL surveillance: serological census survey where prevalence unknown; sample survey (sample size 271–965 dogs depending on estimated prevalence 1–10% and population) in known endemic areas; euthanasia of seropositive dogs is a control measure in some national programmes.
Treatment options for cutaneous, mucosal, or mucocutaneous leishmaniasis by clinical presentation and level of complexity of care
Table extracted from the guideline
| Clinical presentation | Therapeutic interventions | Level of complexity |
|---|---|---|
| Localized CL (1–3 lesions ≤900 mm², no head/periarticular, immunocompetent) | Local: intralesional pentavalent antimonials, thermotherapy, paromomycin 15% cream. Systemic: miltefosine, pentavalent antimonials, pentamidine isethionate | First or second level of care |
| Localized CL (lesions >900 mm² or head/periarticular or multiple or recurrent) | Systemic: miltefosine, pentavalent antimonials, pentamidine isethionate. Special cases: amphotericin B, liposomal amphotericin B | First or second level; special cases second level or reference |
| Disseminated CL | Liposomal amphotericin B, miltefosine, pentavalent antimonials (expert opinion) | Second level or reference center |
| Diffuse CL | Pentavalent antimonials, pentamidine isethionate, miltefosine (expert opinion) | Reference center |
| Mucosal leishmaniasis | Pentavalent antimonials ± pentoxifylline, pentavalent antimonials alone, liposomal amphotericin B, miltefosine, amphotericin B deoxycholate | Reference center |
Source: Pan American Health Organization, Manual of procedures for leishmaniasis surveillance and control in the Region of the Americas. Second edition. Reproduced in summary form.
What changed in this edition
Versus the previous edition
- Treatment chapter fully updated based on 2022 PAHO Guidelines for Treatment of Leishmaniasis in the Americas with GRADE-rated recommendations replacing previous expert consensus
- New recommendations include miltefosine as strong recommendation for CL in adults (L. panamensis, L. mexicana, L. guyanensis, L. braziliensis) and conditional recommendation for pediatrics; intralesional pentavalent antimonials as strong recommendation for localized CL
- Epidemiological classification revised: CL stratification now uses thresholds of <10, 10–50, >50 cases/year or <26, 26–75, >75 per 100,000; VL stratification adds 'silent transmission' category
- Surveillance and control actions updated for each transmission scenario with specific operational guidance on outbreak investigation, active case-finding, entomological surveys, and canine census
- All technical annexes (1–16) revised for laboratory procedures, sample collection, vector identification, canine surveillance; new emphasis on PCR for species identification at regional reference laboratory
- Integration with One Health policy (PAHO 2021) and Disease Elimination Initiative targets for 2030 explicitly incorporated
From the guideline
Verbatim
“It is recommended to use liposomal amphotericin B 3 mg/kg/day for 7 days up to a total dose of 20 mg/kg to treat pediatric and adult immunocompetent patients with visceral leishmaniasis (strong recommendation, low certainty evidence).”
Editor’s perspective
Why this matters for Georgia and the region
Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, Georgian Medical Journal · Chair, Public Health Institute of Georgia · WHO consultant, health and migration
This PAHO manual represents the most comprehensive operational guidance for leishmaniasis control available globally, integrating GRADE-rated treatment recommendations with practical surveillance algorithms that many disease-endemic countries in Latin America have successfully implemented. For Georgian colleagues, the manual's systematic risk stratification methodology—defining transmission intensity thresholds and linking them to specific public-health actions—offers a model applicable to Georgia's surveillance of Crimean-Congo hemorrhagic fever, brucellosis, or emerging vector-borne infections. I would stress to clinicians in our region the diagnostic algorithms for visceral leishmaniasis (rK39 rapid test at primary care, bone marrow aspirate at district hospitals) and the treatment hierarchy (liposomal amphotericin B first-line, avoiding pentavalent antimonials in patients over 50 or with cardiac disease), which would apply to any imported VL cases from endemic regions—an increasing possibility given labor migration from Central Asia. The realistic implementation caveat is that several recommended interventions, particularly canine euthanasia programs and large-scale indoor residual spraying, face substantial ethical, logistical and community acceptance challenges even in highly endemic Latin American settings; Georgia's public-health framework, with its emphasis on rational drug use (as demonstrated in the hepatitis C elimination program) and community engagement (as in the tuberculosis program), would need to adapt these recommendations through pilot studies and stakeholder consultations before any hypothetical leishmaniasis control scenario. The manual's integration of entomological, veterinary and human surveillance aligns well with Georgia's growing One Health capacity, particularly the National Food Agency's veterinary public-health functions and the Lugar Center's vector surveillance capabilities.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 16 Oct 2026
Applicability
Georgia and the South Caucasus
Leishmaniasis is not endemic in Georgia or the South Caucasus; the nearest endemic foci are in southern Europe (Mediterranean basin) and Central Asia (Afghanistan, Pakistan). However, the manual’s systematic approach to vector-borne disease surveillance—risk stratification, case definitions, laboratory network organization by care level, entomological indicators, and outbreak investigation algorithms—offers a valuable template for Georgian public-health programmes managing other vector-borne or zoonotic diseases (e.g., Crimean-Congo hemorrhagic fever, West Nile virus, brucellosis). Georgian physicians may encounter imported leishmaniasis in travelers or migrants from endemic regions (Central Asia, Middle East, Sub-Saharan Africa); the diagnostic algorithms (rK39 rapid test for VL, direct smear for CL) and treatment regimens (liposomal amphotericin B, pentavalent antimonials) would apply. National reference laboratories would need to establish links with WHO/PAHO reference centers for Leishmania species identification by PCR if cases are detected. Climate change may alter vector distribution northward; Georgia’s National Center for Disease Control should monitor sand fly (Phlebotominae) presence as part of entomological surveillance for emerging vector-borne threats.
Questions this guideline answers
Quick answers
What is the first-line treatment for localized cutaneous leishmaniasis with 1–3 small lesions?
For lesions ≤900 mm² (≤3 cm diameter) not on head or joints: intralesional pentavalent antimonials (3–5 infiltrations of 1–5 ml per lesion, 3–7 day intervals) is a strong recommendation with low certainty evidence. Alternatively, miltefosine 2.5 mg/kg/day orally for 28 days (max 150 mg/day) for adults with L. panamensis, L. mexicana, L. guyanensis, or L. braziliensis (strong recommendation, low certainty). Thermotherapy (50 °C for 30 seconds, center and margin, one session) is a conditional recommendation for L. braziliensis, L. panamensis, L. mexicana (very low certainty).
How is visceral leishmaniasis diagnosed in resource-limited primary care settings?
In VL-endemic areas, use the rK39 rapid immunochromatographic test on whole blood or serum at the primary care level for patients with prolonged fever (>1 week) and hepatosplenomegaly. A positive rK39 test confirms the diagnosis and treatment should be started. A negative rK39 in a clinically suspected case requires referral to secondary level for bone marrow aspirate and direct microscopy (53–86% sensitivity). The rK39 test has lower sensitivity in HIV-coinfected patients; direct parasitological methods should be prioritized in immunosuppressed individuals.
Which patients with cutaneous leishmaniasis are at risk of mucosal involvement?
Mucosal leishmaniasis (ML) occurs mainly with L. (V.) braziliensis, L. (V.) panamensis, and L. (V.) guyanensis, typically months to years after cutaneous lesion healing (most within first 2 years). Risk factors include: lesions on head/face, lesions caused by L. braziliensis in certain geographic areas (Bolivia, Paraguay, Peru have higher ML rates: 7.5–55% of all cases), multiple or large cutaneous lesions, and inadequate or no treatment of initial CL. All CL patients require follow-up at 45, 90, 120 days and up to 6 months post-treatment with examination of nasal and oral mucosa to detect early mucosal involvement. ML presents with nasal obstruction, epistaxis, nasal septum perforation, and requires 30 days of systemic pentavalent antimonials (not local treatment).
What surveillance actions are triggered when the first case of visceral leishmaniasis is reported in an area with no previous transmission?
Outbreak investigation is mandatory: (1) confirm diagnosis by bone marrow aspirate or rK39 test and rule out imported case; (2) active case-finding (house-to-house) for human VL in 200 m radius, checking for prolonged fever, hepatosplenomegaly; (3) serological survey of dogs in 1 km radius (sample size 271–965 dogs depending on estimated prevalence 1–10%); (4) entomological survey for Lutzomyia longipalpis (main VL vector) using CDC or Shannon traps in peridomestic areas; (5) map all human and canine cases; (6) if autochthonous transmission confirmed, initiate indoor residual spraying with pyrethroid insecticides in affected households and 200 m perimeter, and implement canine control measures (serological survey, euthanasia of positives where policy allows). Follow-up surveillance quarterly for 2 years.
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- Issuer
- Pan American Health Organization
- Type
- Procedures, manuals, guidelines
- Edition
- Second edition, 2024
- Replaces
- Manual of Procedures for Leishmaniases Surveillance and Control in the Americas, first edition, 2019
- Status
- Current
- Published
- 2024-01-01
- Languages
- English, Spanish (original), Portuguese, French editions available
- Scope
- All forms of leishmaniasis (cutaneous, mucosal, mucocutaneous, visceral, disseminated, diffuse, atypical); surveillance, diagnosis, treatment, vector control, reservoir control; applicable to endemic countries in the Americas from southern United States to northern Argentina
- Audience
- Public-health professionals, clinicians, epidemiologists, laboratory personnel, entomologists, veterinary public-health officers, health managers in leishmaniasis-endemic or at-risk areas
- Pages
- 222
- Licence
- CC BY-NC-SA 3.0 IGO
- ISBN
- 978-92-75-12734-6 (PDF)
- Evidence
- Treatment recommendations: GRADE-rated systematic reviews (2022 PAHO Guidelines); surveillance/control procedures: expert consensus, regional operational experience, updated WHO 2010 technical report
- Next review
- Not stated; previous edition 2019, current edition 2024 suggests approximately 5-year cycle
- Record history
- Created 16 Oct 2026 · updated 16 Oct 2026 · next check Apr 2027
Pan American Health Organization. Manual of procedures for leishmaniasis surveillance and control in the Region of the Americas. Second edition. Washington, D.C.: PAHO; 2024. 222 p. Available from: https://doi.org/10.37774/9789275127346GMJ Guidelines Library records are original summaries written by the GMJ editorial team from the issuer’s published document and reviewed by a physician. They do not replace the full guideline. The document is the copyright of its issuer and is linked, not hosted. Spotted an error or a newer edition? Tell the Guidelines Desk.
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