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01.12.2012 | Research | Ausgabe 1/2012 Open Access

Malaria Journal 1/2012

The efficacy and tolerability of artemisinin-piperaquine (Artequick®) versus artesunate-amodiaquine (Coarsucam™) for the treatment of uncomplicated Plasmodium falciparum malaria in south-central Vietnam

Zeitschrift:
Malaria Journal > Ausgabe 1/2012
Autoren:
Nguyen Xuan Thanh, Trieu Nguyen Trung, Nguyen Chinh Phong, Huynh Hong Quang, Bui Dai, G Dennis Shanks, Marina Chavchich, Michael D Edstein
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1475-2875-11-217) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they have no conflict of interest.

Authors’ contributions

NXT, TNT, BD, GDS and MDE designed the study and developed the protocol. NCP and HHQ executed and coordinated the study. NCP, MC and MDE analysed and interpreted the data. MDE wrote the first draft of the paper. All authors read and approved the final manuscript.

Abstract

Background

In Vietnam, the artemisinin-based combination therapy (ACT) of dihydroartemisinin-piperaquine is currently used for first-line treatment of uncomplicated Plasmodium falciparum malaria. However, limited efficacy and tolerability data are available on alternative forms of ACT in Vietnam in case there is a reduction in the susceptibility of dihydroartemisinin-piperaquine. A study was conducted to compare the efficacy and tolerability of two fixed-dose formulations of ACT, artemisinin–piperaquine (Artequick®, ARPQ) and artesunate-amodiaquine (Coarsucam™, ASAQ) for the treatment of P. falciparum malaria in south-central Vietnam.

Methods

A randomized, open-label trial was conducted comparing the efficacy of a two-day regimen of ARPQ (~2.8 mg/kg artemisinin plus ~17.1 mg/kg of piperaquine per day) and a three-day regimen of ASAQ (~4.7 mg/kg of artesunate plus ~12.6 mg/kg of amodiaquine per day) for the treatment of children and adults with uncomplicated falciparum malaria. Primary efficacy endpoint was day 42, PCR-corrected, parasitological cure rate. Secondary endpoints were parasite and fever clearance times and tolerability.

Results

Of 128 patients enrolled, 63 were administered ARPQ and 65 ASAQ. Of the patients who completed the 42 days follow-up period or had a recurrence of malaria, 55 were on ARPQ (30 children, 25 adults) and 59 were on ASAQ (31 children, 28 adults). Recrudescent parasitaemia was PCR-confirmed for one patient in each treatment group, with cure rates at day 42 of 98% (95% CI: 88–100) for both forms of ACT. The median parasite clearance time was significantly slower in the ARPQ group compared with the ASAQ group (48 h vs. 36 h, P<0.001) and fever clearance times were shorter in the ASAQ group (12 h vs. 24 h, P = 0.07). The two forms of ACT were well tolerated with no serious adverse events.

Conclusion

Both forms of ACT were highly efficacious in the treatment of uncomplicated P. falciparum malaria. Although the two-day course of ARPQ was equally as effective as the three-day course of ASAQ, parasite and fever clearance times were shorter with ASAQ. Further studies are warranted in different regions of Vietnam to determine the nationwide efficacy of ASAQ.

Trial registration

Australian New Zealand Clinical Trials Registry Number, ACTRN12609000816257
Zusatzmaterial
Authors’ original file for figure 1
12936_2012_2129_MOESM1_ESM.pdf
Literatur
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