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

This study has been completed.
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01407887
First received: August 1, 2011
Last updated: December 4, 2012
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Uncomplicated Falciparum Malaria
 Drug: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Artesunate-amodiaquine Combined With Methylene Blue for Falciparum Malaria Treatment in African Children

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • P. falciparum gametocyte prevalence [ Time Frame: day 14 of follow-up ] [ Designated as safety issue: Yes ]
    P. falciparum gametocyte prevalence on day 14 of follow-up (PCR determination)


Secondary Outcome Measures:
  • P. falciparum gametocyte prevalence and density [ Time Frame: day 1, 2, 3, 7, and 28 of follow-up ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 180
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407887

Locations
Burkina Faso
Nouna Health District
Nouna, Mouhoun, Burkina Faso, P.O. Box 34
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Olaf Müller, Prof Dr Institut of Public health, University of heidelberg
  More Information

No publications provided

Responsible Party: Olaf Müller, Prof Dr, Institut of Public Health, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01407887     History of Changes
Other Study ID Numbers: SFB544A8
Study First Received: August 1, 2011
Last Updated: December 4, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Heidelberg:
children

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Amodiaquine
Artesunate
Methylene Blue
Antimalarials
 Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Amebicides

ClinicalTrials.gov processed this record on May 16, 2013