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

Sponsor

Heidelberg University (Other)

Overall Status

Completed

CT.gov ID

NCT01407887

Collaborator

(none)

180

Enrollment

Location

Arms

Duration (Months)

44.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Uncomplicated Falciparum Malaria	Drug: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: artesunate, amodiaquine methylene blue two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Intervention: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) control: artesunate (AS) - amodiaquine (AQ)	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.
No Intervention: artesunate amodiaquine The control group will receive once daily a fixed dose AS-AQ over three days.

Arm

Intervention/Treatment

Active Comparator: artesunate, amodiaquine methylene blue

two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Intervention: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) control: artesunate (AS) - amodiaquine (AQ)

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.

No Intervention: artesunate amodiaquine

The control group will receive once daily a fixed dose AS-AQ over three days.

Outcome Measures

Primary Outcome Measures

P. falciparum gametocyte prevalence [day 14 of follow-up]
P. falciparum gametocyte prevalence on day 14 of follow-up (PCR determination)

Secondary Outcome Measures

P. falciparum gametocyte prevalence and density [day 1, 2, 3, 7, and 28 of follow-up]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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