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NCT Number: NCT01407887

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

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).

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Key information

Conditions

Uncomplicated Falciparum Malaria

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nouna Health District

Nouna, Mouhoun, P.O. Box 34, Burkina Faso

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)

Drug

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 outcomes

  1. P. falciparum gametocyte prevalence

    Time frame: day 14 of follow-up

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

Secondary outcomes

  1. P. falciparum gametocyte prevalence and density

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 2, 2011
Registry last updated
Dec 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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