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

Coulibaly B, Zoungrana A, Mockenhaupt FP, Schirmer RH, Klose C, Mansmann U, Meissner PE, Müller O

PloS one5 May 2009Cited by 91 (Europe PMC)

PMID19415120PMCIDPMC2673582DOI10.1371/journal.pone.0005318PepBankPUB-19415120

Summary

BackgroundWith the availability of new preventive and curative interventions, global malaria control has been strengthened significantly in recent years. Drugs effective in reducing malaria gametocytaemia might contribute to local elimination and possible long-term eradication. We here report on the effects of methylene blue (MB)-based malaria combination therapy on gametocytaemia during a randomised-controlled trial in Burkina Faso.MethodsAn open-label randomised controlled phase II study in 180 children aged 6-10 years with uncomplicated falciparum malaria was conducted in Nouna, north-western Burkina Faso. Children were randomised to MB-artesunate (AS), MB-amodiaquine (AQ), and AS-AQ (local standard of care). Overall follow-up was for 28 days, follow-up for gametocytaemia was for 14 days.FindingsThe treatment groups were similar in baseline characteristics and there was only one loss to follow-up. Compared to AS-AQ, both MB-containing regimens were associated with significantly reduced gametocyte carrier rates during follow-up days 3, 7, and 14. This effect was seen both in patients with and without P. falciparum gametocytaemia at baseline.InterpretationMB reveals pronounced gametocytocidal activity which appears to act against both existing and developing P. falciparum gametocytes. MB-based combination therapy thus has the potential to reduce transmission of P. falciparum malaria in endemic regions, which has important implications for future elimination and eradication strategies.Trial registration(ClinicalTrials.gov) NCT00354380.

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.

01HumanNot a test of Methylene blue aloneRandomized controlled trialEfficacy outcome
In children with falciparum malaria, MB-AS reduced gametocyte carrier rates versus AS-AQ on follow-up days 3, 7, and 14.
In plain wordsIn children with malaria, methylene blue plus artesunate lowered gametocyte carrier rates compared with AS-AQ on follow-up days 3, 7, and 14.
Peptide
Methylene blue
Outcome
DecreaseGametocyte carrier rates with MB-AS
Study
n: not reported in source
Comparator
AS-AQ
Outcome group
Infection and antimicrobial activity · Infection
Source sentences
Summary
Compared to AS-AQ, both MB-containing regimens were associated with significantly reduced gametocyte carrier rates during follow-up days 3, 7, and 14.
3 context sentences(design, population, supporting numbers)
Summary · context
An open-label randomised controlled phase II study in 180 children aged 6-10 years with uncomplicated falciparum malaria was conducted in Nouna, north-western Burkina Faso.
Summary · context
Children were randomised to MB-artesunate (AS), MB-amodiaquine (AQ), and AS-AQ (local standard of care).
Summary · context
Overall follow-up was for 28 days, follow-up for gametocytaemia was for 14 days.
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.
Show in the study text Report a problemFND-1941512001
02HumanNot a test of Methylene blue aloneRandomized controlled trialEfficacy outcome
In children with falciparum malaria, MB-AQ reduced gametocyte carrier rates versus AS-AQ on follow-up days 3, 7, and 14.
In plain wordsIn children with malaria, methylene blue plus amodiaquine lowered gametocyte carrier rates compared with AS-AQ on follow-up days 3, 7, and 14.
Peptide
Methylene blue
Outcome
DecreaseGametocyte carrier rates with MB-AQ
Study
n: not reported in source
Comparator
AS-AQ
Outcome group
Infection and antimicrobial activity · Infection
Source sentences
Summary
Compared to AS-AQ, both MB-containing regimens were associated with significantly reduced gametocyte carrier rates during follow-up days 3, 7, and 14.
3 context sentences(design, population, supporting numbers)
Summary · context
An open-label randomised controlled phase II study in 180 children aged 6-10 years with uncomplicated falciparum malaria was conducted in Nouna, north-western Burkina Faso.
Summary · context
Children were randomised to MB-artesunate (AS), MB-amodiaquine (AQ), and AS-AQ (local standard of care).
Summary · context
Overall follow-up was for 28 days, follow-up for gametocytaemia was for 14 days.
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.
Show in the study text Report a problemFND-1941512002
03HumanNot a test of Methylene blue aloneRandomized controlled trialEfficacy outcome
In children with gametocytaemia at baseline, both MB-containing regimens reduced gametocyte carrier rates versus AS-AQ.
In plain wordsIn children who had gametocytes in the blood at baseline, methylene blue regimens lowered gametocyte carrier rates compared with AS-AQ.
Peptide
Methylene blue
Outcome
DecreaseGametocyte carrier rates with MB-containing regimens in children with baseline gametocytaemia
Study
n: not reported in source
Comparator
AS-AQ
Outcome group
Infection and antimicrobial activity · Infection
Source sentences
Summary
This effect was seen both in patients with and without P. falciparum gametocytaemia at baseline.
Summary
Compared to AS-AQ, both MB-containing regimens were associated with significantly reduced gametocyte carrier rates during follow-up days 3, 7, and 14.
2 context sentences(design, population, supporting numbers)
Summary · context
Children were randomised to MB-artesunate (AS), MB-amodiaquine (AQ), and AS-AQ (local standard of care).
Summary · context
An open-label randomised controlled phase II study in 180 children aged 6-10 years with uncomplicated falciparum malaria was conducted in Nouna, north-western Burkina Faso.
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.
Show in the study text Report a problemFND-1941512003
04HumanNot a test of Methylene blue aloneRandomized controlled trialEfficacy outcome
In children without gametocytaemia at baseline, both MB-containing regimens reduced gametocyte carrier rates versus AS-AQ.
In plain wordsIn children who had no gametocytes in the blood at baseline, methylene blue regimens lowered gametocyte carrier rates compared with AS-AQ.
Peptide
Methylene blue
Outcome
DecreaseGametocyte carrier rates with MB-containing regimens in children without baseline gametocytaemia
Study
n: not reported in source
Comparator
AS-AQ
Outcome group
Infection and antimicrobial activity · Infection
Source sentences
Summary
This effect was seen both in patients with and without P. falciparum gametocytaemia at baseline.
Summary
Compared to AS-AQ, both MB-containing regimens were associated with significantly reduced gametocyte carrier rates during follow-up days 3, 7, and 14.
2 context sentences(design, population, supporting numbers)
Summary · context
Children were randomised to MB-artesunate (AS), MB-amodiaquine (AQ), and AS-AQ (local standard of care).
Summary · context
An open-label randomised controlled phase II study in 180 children aged 6-10 years with uncomplicated falciparum malaria was conducted in Nouna, north-western Burkina Faso.
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.
Show in the study text Report a problemFND-1941512004

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 2NCT00354380

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

Heidelberg UniversitySept 2006 to Nov 2006

Malaria

Trial page ClinicalTrials.govUpdated 24 Oct 2006

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Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

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