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

Sponsor

Heidelberg University (Other)

Overall Status

Completed

CT.gov ID

NCT00354380

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Methylene blue Drug: Artesunate Drug: Amodiaquine	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2006

Study Completion Date :

Nov 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 10 Years

Sexes Eligible for Study:

All

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