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

Primary Purpose

Uncomplicated Falciparum Malaria

Status
Completed
Phase
Phase 2
Locations
Burkina Faso
Study Type
Interventional
Intervention
artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncomplicated Falciparum Malaria focused on measuring children

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Nouna Health District

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

artesunate, amodiaquine methylene blue

artesunate amodiaquine

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
August 1, 2011
Last Updated
December 4, 2012
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT01407887
Brief Title
Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children
Official Title
Efficacy and Safety of Artesunate-amodiaquine Combined With Methylene Blue for Falciparum Malaria Treatment in African Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Falciparum Malaria
Keywords
children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
artesunate, amodiaquine methylene blue
Arm Type
Active Comparator
Arm Description
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)
Arm Title
artesunate amodiaquine
Arm Type
No Intervention
Arm Description
The control group will receive once daily a fixed dose AS-AQ over three days.
Intervention Type
Drug
Intervention Name(s)
artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
P. falciparum gametocyte prevalence
Description
P. falciparum gametocyte prevalence on day 14 of follow-up (PCR determination)
Time Frame
day 14 of follow-up
Secondary Outcome Measure Information:
Title
P. falciparum gametocyte prevalence and density
Description
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)
Time Frame
day 1, 2, 3, 7, and 28 of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olaf Müller, Prof Dr
Organizational Affiliation
Institut of Public health, University of heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nouna Health District
City
Nouna
State/Province
Mouhoun
ZIP/Postal Code
P.O. Box 34
Country
Burkina Faso

12. IPD Sharing Statement

Citations:
PubMed Identifier
25267980
Citation
Coulibaly B, Pritsch M, Bountogo M, Meissner PE, Nebie E, Klose C, Kieser M, Berens-Riha N, Wieser A, Sirima SB, Breitkreutz J, Schirmer RH, Sie A, Mockenhaupt FP, Drakeley C, Bousema T, Muller O. Efficacy and safety of triple combination therapy with artesunate-amodiaquine-methylene blue for falciparum malaria in children: a randomized controlled trial in Burkina Faso. J Infect Dis. 2015 Mar 1;211(5):689-97. doi: 10.1093/infdis/jiu540. Epub 2014 Sep 28.
Results Reference
derived

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

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