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

NCT01407887 | Completed Phase 2 DMC

• 1 other identifier: SFB544A8
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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).

Conditions

Uncomplicated Falciparum Malaria

Keywords

children

Outcome Measures

Primary Outcomes (1)

• P. falciparum gametocyte prevalence

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

  day 14 of follow-up

Secondary Outcomes (1)

• P. falciparum gametocyte prevalence and density

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

Study Arms (2)

artesunate, amodiaquine methylene blue

ACTIVE COMPARATOR

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)

artesunate amodiaquine

NO INTERVENTION

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

Interventions

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.

artesunate, amodiaquine methylene blue

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Simultaneous participation in another investigational study
• Treatment with other investigational drugs

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Nouna Health District

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

Location

Related Publications (1)

• 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.

  PMID: 25267980 DERIVED

MeSH Terms

Interventions

Artesunate; Amodiaquine; Methylene Blue

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Olaf Müller, Prof Dr

  Institut of Public health, University of heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 2, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 5, 2012

Record last verified: 2011-06

Locations

BU (1)