Safety of the methylene blue plus chloroquine combination in the treatment of uncomplicated falciparum malaria in young children of Burkina Faso [ISRCTN27290841].

Meissner PE, Mandi G, Witte S, Coulibaly B, Mansmann U, Rengelshausen J, Schiek W, Jahn A, Sanon M, Tapsoba T, Walter-Sack I, Mikus G and 5 more

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Burhenne J, Riedel KD, Schirmer H, Kouyaté B, Müller O

Malaria journal22 Sept 2005Cited by 52 (Europe PMC)

PMID16179085PMCIDPMC1262758DOI10.1186/1475-2875-4-45PepBankPUB-16179085

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Summary

BackgroundSafe, effective and affordable drug combinations against falciparum malaria are urgently needed for the poor populations in malaria endemic countries. Methylene blue (MB) combined with chloroquine (CQ) has been considered as one promising new regimen.ObjectivesThe primary objective of this study was to evaluate the safety of CQ-MB in African children with uncomplicated falciparum malaria. Secondary objectives were to assess the efficacy and the acceptance of CQ-MB in a rural population of West Africa.MethodsIn this hospital-based randomized controlled trial, 226 children (6-59 months) with uncomplicated falciparum malaria were treated in Burkina Faso. The children were 4:1 randomized to CQ-MB (n = 181; 25 mg/kg CQ and 12 mg/kg MB over three days) or CQ (n = 45; 25 mg/kg over three days) respectively. The primary outcome was the incidence of severe haemolysis or other serious adverse events (SAEs). Efficacy outcomes were defined according to the WHO 2003 classification system. Patients were hospitalized for four days and followed up until day 14.ResultsNo differences in the incidence of SAEs and other adverse events were observed between children treated with CQ-MB (including 24 cases of G6PD deficiency) compared to children treated with CQ. There was no case of severe haemolysis and also no significant difference in mean haemoglobin between study groups. Treatment failure rates were 53.7% (95% CI [37.4%; 69.3%]) in the CQ group compared to 44.0% (95% CI [36.3%; 51.9%]) in the CQ-MB group.ConclusionMB is safe for the treatment of uncomplicated falciparum malaria, even in G6PD deficient African children. However, the efficacy of the CQ-MB combination has not been sufficient at the MB dose used in this study. Future studies need to assess the efficacy of MB at higher doses and in combination with appropriate partner drugs.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

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

01HumanRandomized controlled trialSafety outcome
In children with falciparum malaria, adding methylene blue to chloroquine did not change serious adverse event incidence versus chloroquine alone.
In plain wordsIn children with malaria, adding methylene blue to chloroquine did not change serious adverse events compared with chloroquine alone.
Peptide
Methylene blue
Outcome
No significant changeSerious adverse events
Study
n = 226
Comparator
Chloroquine alone
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
12 mg/kg over three days · three daysAs given in this study (human).
Source sentences
Summary
No differences in the incidence of SAEs and other adverse events were observed between children treated with CQ-MB (including 24 cases of G6PD deficiency) compared to children treated with CQ.
2 context sentences(design, population, supporting numbers)
Summary · context
In this hospital-based randomized controlled trial, 226 children (6-59 months) with uncomplicated falciparum malaria were treated in Burkina Faso.
Summary · context
The children were 4:1 randomized to CQ-MB (n = 181; 25 mg/kg CQ and 12 mg/kg MB over three days) or CQ (n = 45; 25 mg/kg over three days) respectively.
Show in the study text Report a problemFND-1617908501
02HumanRandomized controlled trialEfficacy outcome
In children with falciparum malaria, treatment failure was 44.0% with chloroquine plus methylene blue versus 53.7% with chloroquine alone.
In plain wordsIn children with malaria, treatment failure was 44.0% with chloroquine plus methylene blue versus 53.7% with chloroquine alone.
Peptide
Methylene blue
Outcome
DecreaseTreatment failure
Study
n = 226
Comparator
Chloroquine alone
Analysis
Secondary
Outcome group
Infection and antimicrobial activity · Infection
Studied dose
12 mg/kg over three days · three daysAs given in this study (human).
Measurements
Treatment failure rate
44%
CQ-MB group
Treatment failure rate 95% CI
36.3 to 51.9%
CQ-MB group
Treatment failure rate
53.7%
CQ group
Treatment failure rate 95% CI
37.4 to 69.3%
CQ group
Source sentences
Summary
Treatment failure rates were 53.7% (95% CI [37.4%; 69.3%]) in the CQ group compared to 44.0% (95% CI [36.3%; 51.9%]) in the CQ-MB group.
2 context sentences(design, population, supporting numbers)
Summary · context
In this hospital-based randomized controlled trial, 226 children (6-59 months) with uncomplicated falciparum malaria were treated in Burkina Faso.
Summary · context
The children were 4:1 randomized to CQ-MB (n = 181; 25 mg/kg CQ and 12 mg/kg MB over three days) or CQ (n = 45; 25 mg/kg over three days) respectively.
Show in the study text Report a problemFND-1617908505
03HumanRandomized controlled trialSafety outcome
In children with falciparum malaria, adding methylene blue to chloroquine did not change other adverse event incidence versus chloroquine alone.
In plain wordsIn children with malaria, adding methylene blue to chloroquine did not change other adverse events compared with chloroquine alone.
Peptide
Methylene blue
Outcome
No significant changeOther adverse events
Study
n = 226
Comparator
Chloroquine alone
Outcome group
Adverse events · Whole body
Studied dose
12 mg/kg over three days · three daysAs given in this study (human).
Source sentences
Summary
No differences in the incidence of SAEs and other adverse events were observed between children treated with CQ-MB (including 24 cases of G6PD deficiency) compared to children treated with CQ.
2 context sentences(design, population, supporting numbers)
Summary · context
In this hospital-based randomized controlled trial, 226 children (6-59 months) with uncomplicated falciparum malaria were treated in Burkina Faso.
Summary · context
The children were 4:1 randomized to CQ-MB (n = 181; 25 mg/kg CQ and 12 mg/kg MB over three days) or CQ (n = 45; 25 mg/kg over three days) respectively.
Show in the study text Report a problemFND-1617908502
04HumanRandomized controlled trialSafety outcome
In children with falciparum malaria, mean haemoglobin did not differ significantly between chloroquine plus methylene blue and chloroquine alone.
In plain wordsIn children with malaria, haemoglobin did not differ significantly between chloroquine plus methylene blue and chloroquine alone.
Peptide
Methylene blue
Outcome
No significant changeMean haemoglobin
Study
n = 226
Comparator
Chloroquine alone
Outcome group
Adverse events · Whole body
Studied dose
12 mg/kg over three days · three daysAs given in this study (human).
Source sentences
Summary
There was no case of severe haemolysis and also no significant difference in mean haemoglobin between study groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In this hospital-based randomized controlled trial, 226 children (6-59 months) with uncomplicated falciparum malaria were treated in Burkina Faso.
Summary · context
The children were 4:1 randomized to CQ-MB (n = 181; 25 mg/kg CQ and 12 mg/kg MB over three days) or CQ (n = 45; 25 mg/kg over three days) respectively.
Show in the study text Report a problemFND-1617908504

Studies that did not test the peptide alone1

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.

05HumanNot a test of Methylene blue aloneRandomized controlled trialSafety outcome
In children treated with chloroquine plus methylene blue or chloroquine alone, no severe haemolysis occurred.
In plain wordsIn children receiving chloroquine plus methylene blue or chloroquine alone, no severe red blood cell breakdown occurred.
Peptide
Methylene blue
Outcome
Not applicableSevere haemolysis
Study
n = 226
Analysis
Primary
Outcome group
Adverse events · Whole body
Source sentences
Summary
There was no case of severe haemolysis
3 context sentences(design, population, supporting numbers)
Summary · context
In this hospital-based randomized controlled trial, 226 children (6-59 months) with uncomplicated falciparum malaria were treated in Burkina Faso.
Summary · context
The children were 4:1 randomized to CQ-MB (n = 181; 25 mg/kg CQ and 12 mg/kg MB over three days) or CQ (n = 45; 25 mg/kg over three days) respectively.
Summary · context
The primary outcome was the incidence of severe haemolysis or other serious adverse events (SAEs).
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-1617908503

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.

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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