Status:
UNKNOWN
Short Course Regimens for Treatment of PKDL (Sudan)
Lead Sponsor:
Drugs for Neglected Diseases
Conditions:
PKDL - Post-Kala-Azar Dermal Leishmanioid
Eligibility:
All Genders
6-60 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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 range
- Patients with serum potassium \< 3.5 mmol/L
- Patients with pre-existing clinical hearing loss based on audiometry at baseline
- Patients with a positive HIV test as applicable
- Patients / guardian not willing to participate
- Patients with history of allergy or hypersensitivity to the relevant study drug
- Patients on immunomodulators therapy
Key Trial Info
Start Date :
May 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03399955
Start Date
May 9 2018
End Date
May 1 2022
Last Update
January 18 2020
Active Locations (1)
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1
Prof. Elhassan Centre for tropical Medicine
Doka, Al Qaḑārif, Sudan