Efficacy of methylene blue monotherapy in semi-immune adults with uncomplicated falciparum malaria: a controlled trial in Burkina Faso.
OBJECTIVE
To assess the efficacy of methylene blue (MB) monotherapy in semi-immune adults with uncomplicated malaria in Burkina Faso.


METHODS
In an open-label controlled phase II study with 60 semi-immune adults with uncomplicated falciparum malaria in Nouna, north-western Burkina Faso, MB monotherapy (390 mg twice daily) was given sequentially to groups of 20 adults for 7 days (MB7), 5 days (MB5) and 3 days (MB3), respectively. The primary outcome was the rate of adequate clinical and parasitological response (ACPR) on day 28 of follow-up.


RESULTS
Of the study population, 27/58 (47%) and 5/51 (10%) patients still had parasites on days 2 and 3, respectively, of follow-up resulting in 9/58 (16%) early treatment failures. By day 14, no recrudescence was observed but in 4/19 (MB5) and 2/20 (MB3) individuals by day 28. The PCR-corrected rate of ACPR was 72%, 58% and 85% in groups 7, 5 and 3, respectively, by per protocol analysis. Self-limiting dysuria was the most frequent adverse event.


CONCLUSIONS
MB acts slowly against the blood stages of P. falciparum. MB alone needs to be given for at least 7 days to be efficacious in the treatment of falciparum malaria but should be used in combination with a fast acting antimalarial.
Bountogo
Mamadou
M
Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.
Zoungrana
Augustin
A
Coulibaly
Boubacar
B
Klose
Christina
C
Mansmann
Ulrich
U
Mockenhaupt
Frank P
FP
Burhenne
Jürgen
J
Mikus
Gerd
G
Walter-Sack
Ingeborg
I
Schirmer
R Heiner
RH
Sié
Ali
A
Meissner
Peter
P
Müller
Olaf
O
D000293:Adolescent; D000328:Adult; D000962:Antimalarials / Q000009:adverse effects / Q000627:therapeutic use*; D002050:Burkina Faso; D004334:Drug Administration Schedule; D053159:Dysuria / Q000209:etiology; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D008751:Methylene Blue / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010963:Plasmodium falciparum / Q000302:isolation & purification; D016133:Polymerase Chain Reaction; D016037:Single-Blind Method; D055815:Young Adult
D000962:Antimalarials; D004791:Enzyme Inhibitors; D008751:Methylene Blue