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

Malaria Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354380
• Other study ID #: SFB544-A8-ASMB2006
• Status: Completed
• Phase: Phase 2
• First received: July 19, 2006
• Last updated: October 23, 2006
• Start date: September 2006
• Est. completion date: November 2006

Study information

• Verified date: September 2006
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2006
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Methylene blue

• Artesunate

• Amodiaquine

Locations

Country	Name	City	State
Burkina Faso	Nouna District Hospital	Nouna

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of observed and self-reported non-serious adverse events over the 28 days observation period (definition chapter 11)
Secondary	Incidence of serious adverse events (definition: chapter 11) over the 28 days observation period
Secondary	ACPR rate until D28
Secondary	Early treatment failure (ETF) rate
Secondary	Late clinical failure (LCF) rate at D14 and D28
Secondary	Late parasitological failure (LPF) rate at D14 and D28
Secondary	Fever clearance time
Secondary	Parasite clearance time
Secondary	Change in haematocrit after 2, 3, 7, 14 and 28 days compared to baseline