Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children

Uncomplicated Falciparum Malaria Clinical Trial

Official title:

Efficacy and Safety of Artesunate-amodiaquine Combined With Methylene Blue for Falciparum Malaria Treatment in African Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407887
• Other study ID #: SFB544A8
• Status: Completed
• Phase: Phase 2
• First received: August 1, 2011
• Last updated: December 4, 2012
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: June 2011
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children: randomised controlled trial.

Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso.

Phase: Phase II.

Objectives: The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen.

Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso.

Sample size: 180 patients (90 per study arm).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• 6-59 months old children (male and female)

• Weight = 6kg

• Uncomplicated malaria caused by P. falciparum

• Asexual parasites = 2 000/µl and = 200 000/µl

• Axillary temperature = 37.5°C or a history of fever during last 24 hours

• Burkinabe nationality

• Permanent residence in the study area with no intention of leaving during the surveillance period

• Informed consent

Exclusion Criteria:

• Severe malaria (WHO 2000)

• Vomiting (3 or more within 24 hours before the visit)

• Any apparent significant disease, including severe malnutrition

• A history of a previous, significant adverse reaction to either of the study drugs

• Anaemia (haemoglobin < 7 g/dl)

• Treated in the same trial before

• All modern antimalarial treatment prior to inclusion (last seven days)

• Simultaneous participation in another investigational study

• Treatment with other investigational drugs

Study Design

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

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Uncomplicated Falciparum Malaria

Intervention

Drug:
• artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)
The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined with once daily MB over a three days period.

Locations

Country	Name	City	State
Burkina Faso	Nouna Health District	Nouna	Mouhoun

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P. falciparum gametocyte prevalence	P. falciparum gametocyte prevalence on day 14 of follow-up (PCR determination)	day 14 of follow-up	Yes
Secondary	P. falciparum gametocyte prevalence and density	P. falciparum gametocyte prevalence and density on day 1, 2, 3, 7, and 28 of follow-up (PCR determination) P. falciparum gametocyte prevalence and density on day 1, 2, 3, 7, and 28 of follow-up (microscopic determination)	day 1, 2, 3, 7, and 28 of follow-up	Yes