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Study · Not a test of the peptide alone · 2006

4 results

Methylene blue for malaria in Africa: results from a dose-finding study in combination with chloroquine.

Meissner PE, Mandi G, Coulibaly B, Witte S, Tapsoba T, Mansmann U, Rengelshausen J, Schiek W, Jahn A, Walter-Sack I, Mikus G, Burhenne J and 4 more

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Riedel KD, Schirmer RH, Kouyaté B, Müller O

Malaria journal8 Oct 2006Cited by 72 (Europe PMC)

Summary

The development of safe, effective and affordable drug combinations against malaria in Africa is a public health priority. Methylene blue (MB) has a similar mode of action as chloroquine (CQ) and has moreover been shown to selectively inhibit the Plasmodium falciparum glutathione reductase. In 2004, an uncontrolled dose-finding study on the combination MB-CQ was performed in 435 young children with uncomplicated falciparum malaria in Burkina Faso (CQ monotherapy had a > 50% clinical failure rate in this area in 2003). Three serious adverse events (SAE) occurred of which one was probably attributable to the study medication. In the per protocol safety analysis, there were no dose specific effects. The overall clinical and parasitological failure rates by day 14 were 10% [95% CI (7.5%, 14.0%)] and 24% [95% CI (19.4%, 28.3%)], respectively. MB appears to have efficacy against malaria, but the combination of CQ-MB is clearly not effective in the treatment of malaria in Africa.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone4

In this study, Methylene blue was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Methylene blue.

  1. 01HumanNot a test of Methylene blue aloneNon-randomized trialSafety outcome

    In children with malaria receiving MB-CQ, three serious adverse events occurred, including one probably attributable to the medication.

    In plain wordsIn children with malaria receiving MB-CQ, three serious adverse events occurred, and one was probably due to the medication.

    Outcome
    Not applicableSerious adverse events
    Study

    n = 435

    Outcome group
    Adverse events · Whole body

    Measurements

    Serious adverse events
    3 events
    435 children, MB-CQ
    Serious adverse events probably attributable to study medication
    1 events
    435 children, MB-CQ

    Source sentences

    Summary
    Three serious adverse events (SAE) occurred of which one was probably attributable to the study medication.
    1 context sentence
    Summary · context
    In 2004, an uncontrolled dose-finding study on the combination MB-CQ was performed in 435 young children with uncomplicated falciparum malaria in Burkina Faso (CQ monotherapy had a > 50% clinical failure rate in this area in 2003).

    In this study, Methylene blue was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Methylene blue.

  2. 02HumanNot a test of Methylene blue aloneNon-randomized trialEfficacy outcome

    In children with uncomplicated malaria in an uncontrolled study, the overall clinical failure rate by day 14 with MB-CQ was 10% (95% CI 7.5% to 14.0%).

    In plain wordsIn young children with malaria given methylene blue plus chloroquine and no comparison group, 10% had clinical treatment failure by day 14.

    Outcome
    Not applicableOverall clinical failure rate by day 14
    Study

    n = 435

    Outcome group
    Infection and antimicrobial activity · Infection

    Measurements

    Overall clinical failure rate
    10%
    by day 14, MB-CQ
    95% CI, overall clinical failure rate
    7.5 to 14%
    by day 14, MB-CQ

    Source sentences

    Summary
    The overall clinical and parasitological failure rates by day 14 were 10% [95% CI (7.5%, 14.0%)] and 24% [95% CI (19.4%, 28.3%)], respectively.
    1 context sentence
    Summary · context
    In 2004, an uncontrolled dose-finding study on the combination MB-CQ was performed in 435 young children with uncomplicated falciparum malaria in Burkina Faso (CQ monotherapy had a > 50% clinical failure rate in this area in 2003).

    In this study, Methylene blue was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Methylene blue.

  3. 03HumanNot a test of Methylene blue aloneNon-randomized trialEfficacy outcome

    In children with uncomplicated malaria in an uncontrolled study, the overall parasitological failure rate by day 14 with MB-CQ was 24% (95% CI 19.4% to 28.3%).

    In plain wordsIn young children with malaria given methylene blue plus chloroquine and no comparison group, 24% had parasitological treatment failure by day 14.

    Outcome
    Not applicableOverall parasitological failure rate by day 14
    Study

    n = 435

    Outcome group
    Infection and antimicrobial activity · Infection

    Measurements

    Overall parasitological failure rate
    24%
    by day 14, MB-CQ
    95% CI, overall parasitological failure rate
    19.4 to 28.3%
    by day 14, MB-CQ

    Source sentences

    Summary
    The overall clinical and parasitological failure rates by day 14 were 10% [95% CI (7.5%, 14.0%)] and 24% [95% CI (19.4%, 28.3%)], respectively.
    1 context sentence
    Summary · context
    In 2004, an uncontrolled dose-finding study on the combination MB-CQ was performed in 435 young children with uncomplicated falciparum malaria in Burkina Faso (CQ monotherapy had a > 50% clinical failure rate in this area in 2003).

    In this study, Methylene blue was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Methylene blue.

  4. 04HumanNot a test of Methylene blue aloneNon-randomized trialSafety outcome

    In children with malaria, per-protocol safety analysis of MB-CQ found no dose-specific effects.

    In plain wordsIn children with malaria, MB-CQ safety analysis found no effects specific to different doses.

    Outcome
    No significant changeDose-specific safety effects
    Study

    n: not reported in source

    Comparator
    Other MB-CQ doses
    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    In the per protocol safety analysis, there were no dose specific effects.
    1 context sentence
    Summary · context
    In 2004, an uncontrolled dose-finding study on the combination MB-CQ was performed in 435 young children with uncomplicated falciparum malaria in Burkina Faso (CQ monotherapy had a > 50% clinical failure rate in this area in 2003).

    In this study, Methylene blue was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Methylene blue.

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

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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