Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa

This is a multicenter, non-comparative, open-label clinical trial to assess the Pharmacokinetics (PK) and safety of miltefosine using an allometric dose algorithm in the treatment of children with primary Visceral Leishmaniasis (VL) in eastern Africa. Efficacy and Pharmacodynamics (PD) will be assessed as secondary outcomes.

The proposed study aims to assess whether drug exposure in children can be increased to equivalent adult drug exposure by using the miltefosine allometric dose given BID for 28 days in paediatric VL patients aged 4-12y and whether this dose is tolerable. The present study is also expected to provide the basis for minimum time to reach sufficient drug exposure for miltefosine activity to guide optimal treatment duration to be used in combination therapy for visceral leishmaniasis. The PK data will be assessed in this trial using a compartmental population PK approach.

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Key information

Conditions

Visceral Leishmaniasis Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Visceral Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kacheliba Hospital, Kacheliba, Rift Valley, West Pokot, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with clinical signs and symptoms of VL and confirmatory parasitological microscopic diagnosis
Patients aged > 4 to < 12 years who are able to comply with the study protocol.
Patients for whom written informed consent has been signed by parents(s) or legal guardian
Weight < 30 kg

Exclusion criteria

Patients who are relapse cases
Patients who have received any anti-leishmanial drugs in the last 6 months
Patients with severe malnutrition (for children aged <5 years, weight-for-height WHO reference curves by gender, z score <-3; for children 5-12 years, BMI-for-age WHO reference curves for gender, z score < -3)
Patients with positive HIV diagnosis
Patients with previous history of hypersensitivity reaction to miltefosine
Patients suffering from a concomitant severe infection such as Tuberculosis (TB) or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient's response to study medication
Patients suffering from other conditions associated with splenomegaly such as schistosomiasis
Pregnant or lactating women or female patient in childbearing age (reached menarche)
Patients with haemoglobin < 5g/dl
Patients with White Blood Cells (WBC) < 1 x 10³/mm³
Patients with platelets < 40,000/mm³
Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range.
Patients with bilirubin more than 1.5 times the upper normal range
Patients with serum creatinine above the upper limit of normal (ULN) for age and gender.
Patients with clinical signs of severe VL disease such as jaundice and bleeding
Patients who cannot comply with the planned scheduled visits and procedures of the study protocol

Treatment and study plan

Miltefosine

Drug

Primary outcomes

Pharmacokinetics Parameters (Area Under the Curve (AUC) - composite outcome)

Time frame: During treatment, at 1 and 6 months follow-up

Area Under the Curve calculation is based on several timepoints from first drug intake up to complete elimination of the drug.
Safety (composite outcome) adverse events

Time frame: until day 210
- Frequency of Serious Adverse Events (SAEs) and Adverse Events (AEs) requiring treatment discontinuation, 2. Frequency and severity of adverse events
Pharmacokinetics Parameters (Css/Cmax)

Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Drugs for Neglected Diseases

Other

Registry information

Official study title

An Open-label Clinical Trial to Assess the Pharmacokinetics and Safety of Miltefosine Allometric Dose for the Treatment of Children With Primary Visceral Leishmaniasis in Eastern Africa

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Apr 30, 2015
Registry last updated: Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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