Short Course Regimens for Treatment of PKDL (Sudan) (NCT03399955) | Clinical Trial Compass
UnknownPhase 2
Short Course Regimens for Treatment of PKDL (Sudan)
Sudan110 participantsStarted 2018-05-09
Plain-language summary
This is an open label, randomized non comparative phase II clinical trial conducted on parallel groups, to assess the safety and efficacy of the combination of Paromomycin (20 mg/kg/d) IM for 14 days and Miltefosine (allometric dosing) oral for 42 days, and a combination of AmBisomeĀ® (20 mg/kg total dose) IV over 7 days and Miltefosine oral for 28 days (allometric dosing) for the treatment of PKDL patients in Sudan.
Who can participate
Age range6 Years ā 60 Years
SexALL
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Inclusion Criteria:
* Confirmed PKDL case by clinical presentation and demonstration of parasites by microscopy in a skin smear or by PCR, with documented stable or progressive disease for at least 6 months or grade 3 PKDL
* Male or Female patients aged 6 to 60 years
* Written voluntarily informed consent is obtained from the patient, or his guardian if the patient is \< 18 years old. In the case of minors aged \>12 to \<18, assent from the children is also needed in addition to the guardian's consent.
Exclusion Criteria:
* Patients who had prior treatment of PKDL within the last 1 year
* Pregnant and lactating women and women of childbearing age (12 to 55 years) who do not accept to have a pregnancy test and who do not agree to use contraception during treatment period and for 5 months after the end of treatment.
* Patients with signs and symptoms of severe diseases: defined as suffering from a concomitant severe infection such as TB or any other serious known underlying disease (cardiac, renal, hepatic),
* Severe malnutrition defined by BMI for age WHO reference curves for gender, Z score \< -3 for subjects 6 to \< 19 years; BMI \< 16 for subjects \> 19 years old
* Patients with haemoglobin \< 5g/dL
* Patients with known skin disease
* Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range.
* Patients with total bilirubin levels \>1.5 times the upper normal range
* Patients with serum creatinine above the upper limit of normalā¦
What they're measuring
1
Definitive Cure
Timeframe: 12 months follow-up assessment
2
Incidence of treatment-emergent adverse events
Timeframe: from start of treatment to 12 month follow-up