A Phase 3 interventional study of Miltefosine and Paromomycin in Visceral Leishmaniasis, sponsored by Drugs for Neglected Diseases. Completed at 7 sites in 4 countries. Open to participants aged 4 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Drugs for Neglected Diseases · Phase 3, Interventional, and Treatment
This is an open label, Phase III, randomized, controlled, parallel arm multicentre non-inferiority clinical trial to compare the efficacy and safety of two combination regimens of Miltefosine and Paromomycin with the standard SSG-PM for the treatment of primary adult and children VL patients in Eastern Africa.
The 2 treatment regimens to be tested are:
The reference arm is the current standard treatment for VL:
The target population will be VL patients from 4 to 50 years old in order to cover both paediatric and adult population.
Patients will be hospitalized for 14 days of PM and MF treatment for both arm 1 and arm 2. MF treatment will start at the same time as PM treatment and for arm 2 it will continue on an out-patient basis until completion of the 28 days treatment.
SSG\&PM combination therapy will be administered for 17 days according to routine VL treatment guidelines and patients will remain hospitalized for the entire duration of the treatment.
All patients will be asked to return to the hospital for a full assessment on day 28, and for followup visits on day 56 and at six months.
To respond to the objectives, study assessments will be carried out at screening and on days 1, 3, 7, 14, 21, 28, 56 (one-month post-treatment) and 210 (six-month post-treatment). These assessments will include clinical, parasitological, haematological, biochemistry, safety, pharmacokinetic and pharmacodynamics assessments.
Exclusion Criteria:
Patients who cannot comply with the planned scheduled visits and procedures of the study protocol
Paromomycin 20 mg/kg/d IM for 14 days combined with oral miltefosine allometric dosing for 14 days
Drug: Miltefosine · Drug: Paromomycin
Paromomycin 20 mg/kg/d IM for 14 days combined with oral miltefosine allometric dosing for 28 days
Drug: Miltefosine · Drug: Paromomycin
Sodium Stibogluconate 20 mg/kg/day IM/IV combined with Paromomycin 15 mg/kg/day IM for 17 days
Drug: Paromomycin · Drug: Sodium stibogluconate
Miltefosine 10mg and 50mg capsules
Also known as: Impavido
Paromomycin sulfate equiv to 750mg paromomycin / 2ml amp
Also known as: Paromomycin sulfate
Sodium stibogluconate 33% 30 ml inj.
Also known as: SSG
Definitive Cure
Cure at 6 months follow up defined as absence of clinical signs and symptoms of VL at D210 and no requirement for rescue treatment during the trial (e.g. no relapse or initial treatment failure).
Time frame: 6 months follow-up (Day 210)
Incidence of Treatment-Emergent Adverse Events
1. Frequency of SAEs and AEs requiring treatment discontinuation 2. Frequency and severity of adverse events from the start of treatment through the last visit, at day 210.
Time frame: From Screening to day 210
Initial cure at day 28
Initial cure: cure at the end of treatment (Day 28), defined as recovery of clinical signs and symptoms; absence of parasites (microscopy) and no rescue treatment administered up to and including Day 28. Probable cure: absence of clinical signs and symptoms of VL at D56 and no prior requirement for rescue medication.
Time frame: Initial cure: day 28; Probable cure: day 56
Pharmacokinetics of paromomycin and miltefosine
Total and partial blood plasma exposure to paromomycin and miltefosine defined as the area under the concentration-time curve
Time frame: During treatment, at 1 month (day 56) and 6 months (day 210) follow-up
Pharmacodynamics
Blood parasite clearance over time (qualitative and quantitative), as measured by qPCR from blood samples
Time frame: From baseline until day 210, and at any suspicion of relapse during the trial.
Compliance to miltefosine treatment in an outpatient setting
Compliance to MF treatment in an outpatient setting will be assessed through patients' hospital records history, drug accountability and PK measurements.
Time frame: Day 15 to day 28 miltefosine treatment
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Drugs for Neglected Diseases