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 AmBisome® (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 range
6 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 normal…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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