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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT01407887 (opens ClinicalTrials.gov in a new tab)Other idSFB544A8
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Overview

Status
Completed
Phase
Phase 2
Enrollment
180 participants (actual)
Sponsor
Heidelberg University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Burkina Faso

Start
Aug 2011
Primary completion
Aug 2011
Completion
Dec 2011
First posted
2 Aug 2011 (estimated)
Last update posted
5 Dec 2012 (estimated)
Conditions
Uncomplicated Falciparum Malaria

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012
  1. Ph 2

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

    NCT01407887

    Aug 2011 to Dec 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

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

Arms2

  • 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)

  • No intervention

    artesunate amodiaquine

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. P. falciparum gametocyte prevalence

    Time frame · day 14 of follow-up

    Registry description

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

Secondary outcomes(1)

  1. P. falciparum gametocyte prevalence and density

    Time frame · day 1, 2, 3, 7, and 28 of follow-up

    Registry 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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

4 results

Efficacy and safety of triple combination therapy with artesunate-amodiaquine-methylene blue for falciparum malaria in children: a randomized controlled trial in Burkina Faso.

Coulibaly et al. 2015The Journal of infectious diseasescited by 47

PMID 25267980DOI 10.1093/infdis/jiu540PUB-25267980

Rights unknown4 results
Source linkSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Months up to 59 Months
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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