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

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


Further study details as provided by Heidelberg University:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Heidelberg University
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 Heidelberg University:
children

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

ClinicalTrials.gov processed this record on October 16, 2014