Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study

Heidelberg University

Overview

The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of MB-AS and MB-AQ.

Objectives: The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) given over three days in 6-10 year old children with uncomplicated falciparum malaria in a malaria endemic area compared to the safety of a three days AS-AQ regimen. Secondary objectives are to investigate the efficacy of MB-AS and MB-AQ. Population: Children aged 6-10 years with uncomplicated malaria from Nouna town. Sample size: N= 180 (n=60 for each group). Treatment: The participants in the MB-AS group will receive orally twice daily 9mg/kg MB combined with once daily 4mg/kg AS over 3 days. The participants in the MB-AQ group will receive orally twice daily 9mg/kg MB combined with once daily 10mg/kg AQ over 3 days. The participants of the comparator group will receive a 3 day regimen of once daily oral AS (4mg/kg) combined with once daily AQ (10mg/kg). Endpoints: The primary endpoint is the number of adverse events (AE) after drug intake until day 28. Secondary endpoints are the number of serious adverse events (SAE), adequate clinical and parasitological response (ACPR) rate on day 28, clinical and parasitological failure rates on day 3, 7, 14 and 28, changes in haematocrit until day 28, and fever and parasite clearance time.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Malaria

Interventions

Methylene blueDRUG

ArtesunateDRUG

AmodiaquineDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 10 Years

Medical Language ↔ Plain English

Inclusion criteria: * 6-10 year old children * Ability to swallow tablets * Uncomplicated malaria caused by P. falciparum * Asexual parasites ≥ 2000/µl and \< 200000/µl * Axillary temperature ≥ 37.5°C * Burkinabe nationality * Informed consent Exclusion Criteria: * Complicated or severe malaria * Any apparent significant disease * Anaemia (haematocrit \< 21%) * Treated in the same trial before * Antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine

Locations (1)

Nouna District Hospital

Nouna, Burkina Faso

Outcomes

Primary Outcomes

Incidence of observed and self-reported non-serious adverse events over the 28 days observation period (definition chapter 11)

Secondary Outcomes

Incidence of serious adverse events (definition: chapter 11) over the 28 days observation period

ACPR rate until D28

Early treatment failure (ETF) rate

Late clinical failure (LCF) rate at D14 and D28

Late parasitological failure (LPF) rate at D14 and D28

Fever clearance time

Parasite clearance time

Change in haematocrit after 2, 3, 7, 14 and 28 days compared to baseline

Data from ClinicalTrials.gov

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