Publication: Efficacy and day 7 plasma piperaquine concentrations in African children treated for uncomplicated malaria with dihydroartemisinin-piperaquine.
Accepted Date
2014-06-24
Issued Date
2014-08-18
Copyright Date
2014
Resource Type
Language
eng
ISSN
1932-6203 (electronic)
Rights
Mahidol University
Rights Holder(s)
PloS one
Bibliographic Citation
Zongo I, Somé FA, Somda SA, Parikh S, Rouamba N, Rosenthal PJ, et al. Efficacy and day 7 plasma piperaquine concentrations in African children treated for uncomplicated malaria with dihydroartemisinin-piperaquine. PLoS One. 2014 Aug 18;9(8):e103200.
Suggested Citation
Zongo, Issaka, Some, Fabrice A., Somda, Serge A. M., Parikh, Sunil, Rouamba, Noel, Rosenthal, Philip J., Tarning, Joel, Lindegardh, Niklas, Nosten, Franc¸ois, Oue´draogo, Jean Bosco Efficacy and day 7 plasma piperaquine concentrations in African children treated for uncomplicated malaria with dihydroartemisinin-piperaquine.. Zongo I, Somé FA, Somda SA, Parikh S, Rouamba N, Rosenthal PJ, et al. Efficacy and day 7 plasma piperaquine concentrations in African children treated for uncomplicated malaria with dihydroartemisinin-piperaquine. PLoS One. 2014 Aug 18;9(8):e103200.. doi:10.1371/journal.pone.0103200 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/767
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Title
Efficacy and day 7 plasma piperaquine concentrations in African children treated for uncomplicated malaria with dihydroartemisinin-piperaquine.
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Abstract
BACKGROUND: One promising new Artemisinin-based combination therapies (ACTs) is
dihydroartemisinin-piperaquine (DHA-PQ). However, the pharmacokinetics of
piperaquine and the relationship between drug levels and clinical efficacy are
incompletely characterized, particularly in children.
METHODS: We performed a single-arm open-label trial in Bobo-Dioulasso, Burkina
Faso. A total of 379 participants aged 6 months or more with uncomplicated
falciparum malaria were enrolled. Each participant received daily dose of DHA-PQ
for three days and followed for 42 days. Parasitological efficacy was analyzed,
considering rates of recrudescence and overall recurrence. PK was an exploratory
endpoint and a priori, no sample size had been determined. Day 7 capillary and
venous plasma concentrations of piperaquine were measured in children aged 2-10
years.
RESULTS: Of the 379 participants, 365 (96.3%) completed 42 days of follow-up. The
median daily dose of PQ was 18.5 mg/kg [6.5-24]. Treatment with DHA-PQ was well
tolerated with fever and parasitemia resolution within 48 hours in nearly all
children. Recurrent malaria within 42 days of follow-up occurred in 31.3% (10/34)
of children less than 2 years old, 16.0% (16/106) of those aged 2-5 years, 9.4%
(15/160) of those aged 5-10 years, and none (0/68) of those over 10 years old.
After genotyping, 3 of 41 recurrent episodes were recrudescence. An exploratory
analysis shows that children with successful treatment outcomes had significantly
higher median plasma concentrations of PQ compared to those with recurrent
malaria within 42 days after therapy, considering either capillary samples (68
ng/ml [50-85] compared to 48 ng/ml [36-55], p<0.001) or venous samples (42 ng/ml
[29-59] compared to 25 ng/ml [19-44], p<0.001).
CONCLUSION: DHA-PQ was effective for uncomplicated P. falciparum malaria
treatment and offers an alternative to other ACTs. Recurrent malaria was mainly
due to new infections after treatment and was correlated with low day 7 PQ
concentration in the youngest patients.
TRIAL REGISTRATION: Controlled-Trials.com ISRCTN59761234.