A pilot study to examine the cure rates of oral miltefosine and sodium stibogluconate for treating Old World Cutaneous Leishmaniasis in Kandahar, Afghanista
- Conditions
- pharmacokineticAfghanistaneishmaniasis, CutaneousMiltefosine
- Registration Number
- TCTR20180710007
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 103
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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