Short Course Regimens for Treatment of PKDL (Sudan)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2022-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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PKDL - Post-Kala-Azar Dermal Leishmanioid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Paromomycin + Miltefosine

Paromomycin 20 mg/kg/d IM for 14 days combined with Miltefosine allometric BID PO dosing for 42 days

Group Type EXPERIMENTAL

Paromomycin

Intervention Type DRUG

Paromomycin (20 mg/kg/d) IM for 14 days

Miltefosine

Intervention Type DRUG

Miltefosine oral (allometric dosing) for 42 days (arm 1) or 28 days (arm 2)

Arm 2: Ambisome + Miltefosine

AmBisome® 5mg/kg/d IV infusion at D1, D3, D5 and D7 (20 mg/kg total dose) combined with Miltefosine allometric BID PO dosing for 28 days

Group Type EXPERIMENTAL

Ambisome

Intervention Type DRUG

AmBisome® (20 mg/kg total dose) IV over 7 days

Miltefosine

Intervention Type DRUG

Miltefosine oral (allometric dosing) for 42 days (arm 1) or 28 days (arm 2)

Interventions

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Paromomycin

Paromomycin (20 mg/kg/d) IM for 14 days

Intervention Type DRUG

Ambisome

AmBisome® (20 mg/kg total dose) IV over 7 days

Intervention Type DRUG

Miltefosine

Miltefosine oral (allometric dosing) for 42 days (arm 1) or 28 days (arm 2)

Intervention Type DRUG

Other Intervention Names

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Liposomal Amphotericin B Impavido

Eligibility Criteria

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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 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

Minimum Eligible Age

6 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No