Leishmaniasis, Cutaneous Miltefosine pharmacokinetic Afghanistan
Conditions
Interventions
IL SSB is usually given x1 / week x 4 w
If lesion does not heal, SSB is given for 2-4 more weeks,IM SSB is dosed at 20 mg Sb5+/kg/day × 20d,Miltefosine comes in two tablet strengths: 50 mg and 10 mg.
Sodium stibogluconate (SSB) by Intralesional (IL) ,Sodium stibogluconate (SSB) by Intramuscular (IM) ,Miltefosine Oral Product
Sponsors
University of Oxford
Wellcome Trust grant reference 220211
Eligibility
Sex/Gender
All
Age
1 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. age greater than or equal to 1 to 60 years old male 2. age greater than or equal to 1 to less than14 years for females 3. weight greater than or equal to 10 kg 4. presentation with amastigote positive, by Giemsa-stained smear, cutaneous lesion(s) 5. lesions needing systemic treatment, any one of the following: 5.1 greater than or equal to 1 lesion that is active and measuring greater than or equal to 3 cm in a patient aged greater than or equal to 5 y (even if other lesions maybe less than 3cm) 5.2 greater than or equal to 1 lesion that is active and measuring greater than or equal to 2 cm in a child aged less than 5 y (even if other lesions maybe less than 2cm) 5.3 are located on the ears, or fingers, or toes, or face, or near the eyes, or nose, or lips (irrespective of the size) 5.4 greater than or equal to 1 lesion that is associated with easily palpable regional lymph nodes, irrespective of the size 5.5 greater than or equal to 1 lesion that is over a joint, irrespective of the size 5.6 greater than or equal to 3 lesions, irrespective of size 5.7 lupoid or sporotrichoid lesions, irrespective of the size
Exclusion criteria
Exclusion criteria: 1. severe lesions requiring hospital treatment i.e. surgery and/or IV SSB (physician s decision) 2. solitary lesion less than 2 cm in a child less than 5y or less than 3 cm in a patient aged greater than or equal to 5 y 3. all women aged greater than or equal to 14 years 4. pregnant or breast feeding female 5. female intending to have a child in the next 12 months 6. known allergy to SSB or miltefosine 7. known serious underlying disease e.g. liver, renal, cardiac disease, HIV, tuberculosis, on systemic steroids 8. creatinine clearance less than 30 mL/min (Cockcroft Gault, Schwartz formulae)* 9. ALT greater than 3 x upper limit of normal (ULN) 10. Total bilirubin greater than 1.5 x ULN 11. Presence of an abnormal cardiac rhythm 12. Prolonged QTc interval (Bazzet s correction) (Rijnbeek, Witsenburg et al. 2001) (Pearl 1996): 12.1 age 5 to less than12: greater than or equal to 470 ms (females) or greater than or equal to 460 ms (males) 12.2 age 12 to less than18: greater than or equal to 480 ms (females) or greater than or equal to 470 ms (males) 12.3 age greater than or equal to 18: greater than or equal to 470 ms (females) or greater than or equal to 450 ms (males)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure for ulcerated lesions 6 months Cure defined by re-epithelization for ulcerated lesions,Cure for non-ulcerated lesions 6 months Cure defined by flattening for non-ulcerated lesions | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to cure 6 months Time in weeks,Miltefosine phamacokinetics and phamacodynamics for parasite clearance 6 months DNA copy number / mg of miltefosine,Miltefosine phamacokinetics and phamacodynamics for lesional size reduction 6 months Assessed by photographs and image analysis,Treatment failure 14 days defined as any one of increasing skin lesion ≤ 14 days starting treatment,Relapse rate 6 months reappearance of original skin lesion ≤ 6m after 'cure',A slow curing lesion as defined as Day 42 42 days <50% re-epithelization (ulcer) or flattening (non-ulcerated lesion),A slow curing lesion as defined as Day 90 90 days <100% re-epithelization (ulcer) or flattening (non-ulcerated lesion),Adverse events 6 months The number of adverse events,Dermatology Life Quality Index (DLQI) 6 months The DLQI score | — |
Countries
Afghanistan
Contacts
Public ContactBob Taylor
Mahidol Oxford Tropical Medicine Clinical Research unit (MORU)
Outcome results
None listed