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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT00354380 (opens ClinicalTrials.gov in a new tab)Other idSFB544-A8-ASMB2006
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Overview

Status
Completed
Phase
Phase 2
Enrollment
Not stated
Sponsor
Heidelberg University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Burkina Faso

Start
Sept 2006
Primary completion
Not stated
Completion
Nov 2006
First posted
20 Jul 2006 (estimated)
Last update posted
24 Oct 2006 (estimated)
Conditions
Malaria

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062007
  1. Ph 2

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

    NCT00354380

    Sept 2006 to Nov 2006

Registry summary

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

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.

Interventions

  • Methylene blueDrug
  • ArtesunateDrug
  • AmodiaquineDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of observed and self-reported non-serious adverse events over the 28 days observation period (definition chapter 11)

Secondary outcomes(8)

  1. Incidence of serious adverse events (definition: chapter 11) over the 28 days observation period

  2. ACPR rate until D28

  3. Early treatment failure (ETF) rate

  4. Late clinical failure (LCF) rate at D14 and D28

  5. Late parasitological failure (LPF) rate at D14 and D28

  6. Fever clearance time

  7. Parasite clearance time

  8. Change in haematocrit after 2, 3, 7, 14 and 28 days compared to baseline

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2009

4 results

Strong gametocytocidal effect of methylene blue-based combination therapy against falciparum malaria: a randomised controlled trial.

Coulibaly et al. 2009PloS onecited by 91

PMID 19415120PMC2673582DOI 10.1371/journal.pone.0005318PUB-19415120

CC BY4 results
Download PDFSee results (4)

Indexing hint: Randomized controlled trial · 2008

12 results

Safety and efficacy of methylene blue combined with artesunate or amodiaquine for uncomplicated falciparum malaria: a randomized controlled trial from Burkina Faso.

Zoungrana et al. 2008PloS onecited by 67

PMID 18286187PMC2238815DOI 10.1371/journal.pone.0001630PUB-18286187

CC BY12 results
Download PDFSee results (12)

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Years up to 10 Years
Healthy volunteers
Not stated
Inclusion and exclusion criteria, as posted
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

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