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

Malaria Clinical Trial

Official title:

Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso: RCT in the Frame of the A8 Project of SFB 544

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545935
• Other study ID #: MB-2007b
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2007
• Last updated: February 2, 2009
• Start date: July 2007
• Est. completion date: October 2007

Study information

• Verified date: February 2009
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: October 2007
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• 0.5-5 year (6-59 months) old children

• uncomplicated malaria caused by P. falciparum

• asexual parasites = 2000/µ and = 200000/µ

• axillary temperature = 37.5 Celsius or a history of fever during last 24 hours

• Burkinabe nationality

• informed consent

Exclusion Criteria:

• complicated or severe malaria

• any apparent significant disease

• anaemia (haematocrit < 21%)

• treated in the same trial before

• modern 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:
• Methylenblue-Amodiaquine (MB-AQ)
For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ
• Methylenblue-Artesunate (MB-AS)
3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days
• Artesunate-Amodiaquine (AS-AQ)
For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.

Locations

Country	Name	City	State
Burkina Faso	Centre de Recherche en Sante de Nouna	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		28 days	Yes
Secondary	Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)		28 days	Yes
Secondary	Early treatment failure (ETF) rate		28 days	Yes
Secondary	Late clinical failure (LCF) rate at D14 and D28		28 days	Yes
Secondary	Late parasitological failure (LPF) rate at D14 and D28		28 days	Yes
Secondary	Fever clearance time		28 days	Yes
Secondary	Parasite clearance time		28 days	Yes
Secondary	Change in haematocrit after 2,14 and 28 days compared to baseline		28 days	Yes
Secondary	MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose		28 days	Yes