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Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study

NCT ID: NCT00354380

Last Updated: 2006-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2006-11-30

Brief Summary

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The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of MB-AS and MB-AQ.

Detailed Description

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Objectives: The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) given over three days in 6-10 year old children with uncomplicated falciparum malaria in a malaria endemic area compared to the safety of a three days AS-AQ regimen. Secondary objectives are to investigate the efficacy of MB-AS and MB-AQ.

Population: Children aged 6-10 years with uncomplicated malaria from Nouna town.

Sample size: N= 180 (n=60 for each group).

Treatment: The participants in the MB-AS group will receive orally twice daily 9mg/kg MB combined with once daily 4mg/kg AS over 3 days. The participants in the MB-AQ group will receive orally twice daily 9mg/kg MB combined with once daily 10mg/kg AQ over 3 days. The participants of the comparator group will receive a 3 day regimen of once daily oral AS (4mg/kg) combined with once daily AQ (10mg/kg).

Endpoints: The primary endpoint is the number of adverse events (AE) after drug intake until day 28. Secondary endpoints are the number of serious adverse events (SAE), adequate clinical and parasitological response (ACPR) rate on day 28, clinical and parasitological failure rates on day 3, 7, 14 and 28, changes in haematocrit until day 28, and fever and parasite clearance time.

Conditions

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Malaria

Keywords

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Malaria Africa Methalyne-blue Artesunate Amodiaquine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Methylene blue

Intervention Type DRUG

Artesunate

Intervention Type DRUG

Amodiaquine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 6-10 year old children
* Ability to swallow tablets
* Uncomplicated malaria caused by P. falciparum
* Asexual parasites ≥ 2000/µl and \< 200000/µl
* Axillary temperature ≥ 37.5°C
* Burkinabe nationality
* Informed consent

Exclusion Criteria

* Complicated or severe malaria
* Any apparent significant disease
* Anaemia (haematocrit \< 21%)
* Treated in the same trial before
* Antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Principal Investigators

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Olaf Mueller, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Peter Meissner, MD, MSc Trop Paed

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

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Nouna District Hospital

Nouna, , Burkina Faso

Site Status

Countries

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Burkina Faso

References

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Coulibaly B, Zoungrana A, Mockenhaupt FP, Schirmer RH, Klose C, Mansmann U, Meissner PE, Muller O. Strong gametocytocidal effect of methylene blue-based combination therapy against falciparum malaria: a randomised controlled trial. PLoS One. 2009;4(5):e5318. doi: 10.1371/journal.pone.0005318. Epub 2009 May 5.

Reference Type DERIVED
PMID: 19415120 (View on PubMed)

Zoungrana A, Coulibaly B, Sie A, Walter-Sack I, Mockenhaupt FP, Kouyate B, Schirmer RH, Klose C, Mansmann U, Meissner P, Muller O. Safety and efficacy of methylene blue combined with artesunate or amodiaquine for uncomplicated falciparum malaria: a randomized controlled trial from Burkina Faso. PLoS One. 2008 Feb 20;3(2):e1630. doi: 10.1371/journal.pone.0001630.

Reference Type DERIVED
PMID: 18286187 (View on PubMed)

Other Identifiers

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SFB544-A8-ASMB2006

Identifier Type: -

Identifier Source: org_study_id