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Study · Randomized controlled trial · n = 221 · 2015

4 results

Efficacy and safety of triple combination therapy with artesunate-amodiaquine-methylene blue for falciparum malaria in children: a randomized controlled trial in Burkina Faso.

Coulibaly B, Pritsch M, Bountogo M, Meissner PE, Nebié E, Klose C, Kieser M, Berens-Riha N, Wieser A, Sirima SB, Breitkreutz J, Schirmer RH and 5 more

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Sié A, Mockenhaupt FP, Drakeley C, Bousema T, Müller O

The Journal of infectious diseases28 Sept 2014Cited by 47 (Europe PMC)

PMID25267980 (opens in a new tab)DOI10.1093/infdis/jiu540 (opens in a new tab)PepBankPUB-25267980
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In children with malaria, adding methylene blue to AS-AQ reduced microscopy gametocyte prevalence versus AS-AQ.

    In plain wordsIn children with malaria, methylene blue plus AS-AQ reduced gametocyte prevalence by microscopy compared with AS-AQ.

    Peptide
    Methylene blue
    Outcome
    DecreaseGametocyte prevalence by microscopy at day 7
    Study

    n = 221

    Comparator
    AS-AQ
    Analysis
    Primary
    Outcome group
    Infection and antimicrobial activity · Infection
    Studied dose
    Dose not stated · 3 daysAs given in this study (human).

    Measurements

    Gametocyte prevalence
    1.2%
    day 7, microscopy, AS-AQ-MB
    Gametocyte prevalence
    8.9%
    day 7, microscopy, AS-AQ

    Source sentences

    Summary
    It was significantly lower in the AS-AQ-MB than in the AS-AQ group on day 7 of follow-up (microscopy, 1.2% vs 8.9% [P < .05]; QT-NASBA, 36.7% vs 63.3% [P < .001]).
    2 context sentences
    Summary · context
    Three days of treatment with artesunate (AS)-amodiaquine (AQ) combined with MB was compared with AS-AQ treatment in a randomized controlled phase IIb study; the study included 221 children aged 6-59 months with uncomplicated falciparum malaria in Burkina Faso.
    Summary · context
    The primary end point was gametocyte prevalence during follow-up, as determined by microscopy and real-time quantitative nucleic acid sequence-based amplification (QT-NASBA).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In children with malaria, adding methylene blue to AS-AQ reduced QT-NASBA gametocyte prevalence versus AS-AQ.

    In plain wordsIn children with malaria, methylene blue plus AS-AQ reduced gametocyte prevalence by QT-NASBA compared with AS-AQ.

    Peptide
    Methylene blue
    Outcome
    DecreaseGametocyte prevalence by QT-NASBA at day 7
    Study

    n = 221

    Comparator
    AS-AQ
    Analysis
    Primary
    Outcome group
    Infection and antimicrobial activity · Infection
    Studied dose
    Dose not stated · 3 daysAs given in this study (human).

    Measurements

    Gametocyte prevalence
    36.7%
    day 7, QT-NASBA, AS-AQ-MB
    Gametocyte prevalence
    63.3%
    day 7, QT-NASBA, AS-AQ

    Source sentences

    Summary
    It was significantly lower in the AS-AQ-MB than in the AS-AQ group on day 7 of follow-up (microscopy, 1.2% vs 8.9% [P < .05]; QT-NASBA, 36.7% vs 63.3% [P < .001]).
    2 context sentences
    Summary · context
    Three days of treatment with artesunate (AS)-amodiaquine (AQ) combined with MB was compared with AS-AQ treatment in a randomized controlled phase IIb study; the study included 221 children aged 6-59 months with uncomplicated falciparum malaria in Burkina Faso.
    Summary · context
    The primary end point was gametocyte prevalence during follow-up, as determined by microscopy and real-time quantitative nucleic acid sequence-based amplification (QT-NASBA).
  3. 03HumanRandomized controlled trialSafety outcome

    In children with malaria, adding methylene blue to AS-AQ lowered hemoglobin versus AS-AQ at both reported follow-up times.

    In plain wordsIn children with malaria, methylene blue plus AS-AQ lowered hemoglobin compared with AS-AQ.

    Peptide
    Methylene blue
    Outcome
    DecreaseHemoglobin at days 2 and 7
    Study

    n = 221

    Comparator
    AS-AQ
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 3 daysAs given in this study (human).

    Source sentences

    Summary
    Hemoglobin values were significantly lower in the AS-AQ-MB group than in the AS-AQ group at days 2 and 7 of follow-up.
    1 context sentence
    Summary · context
    Three days of treatment with artesunate (AS)-amodiaquine (AQ) combined with MB was compared with AS-AQ treatment in a randomized controlled phase IIb study; the study included 221 children aged 6-59 months with uncomplicated falciparum malaria in Burkina Faso.
  4. 04HumanRandomized controlled trialSafety outcome

    In children with malaria, vomiting occurred more often with AS-AQ-methylene blue than AS-AQ.

    In plain wordsIn children with malaria, vomiting occurred more often with methylene blue plus AS-AQ than AS-AQ.

    Peptide
    Methylene blue
    Outcome
    IncreaseVomiting
    Study

    n = 221

    Comparator
    AS-AQ
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 3 daysAs given in this study (human).

    Source sentences

    Summary
    Vomiting of the study medication occurred significantly more frequently in the AS-AQ-MB group.
    1 context sentence
    Summary · context
    Three days of treatment with artesunate (AS)-amodiaquine (AQ) combined with MB was compared with AS-AQ treatment in a randomized controlled phase IIb study; the study included 221 children aged 6-59 months with uncomplicated falciparum malaria in Burkina Faso.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT01407887

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

Heidelberg Universityn = 180Aug 2011 to Dec 2011

Uncomplicated Falciparum Malaria

Trial pageClinicalTrials.govUpdated 5 Dec 2012

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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