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A randomized comparison of dihydroartemisinin-piperaquine and artesunate-amodiaquine combined with primaquine for radical treatment of vivax malaria in Sumatera, Indonesia.

Pasaribu AP, Chokejindachai W, Sirivichayakul C, Tanomsing N, Chavez I, Tjitra E, Pasaribu S, Imwong M, White NJ, Dondorp AM - J. Infect. Dis. (2013)

Bottom Line: Which combination is most effective and safe remains to be established.Both treatments were safe, but DHP + PQ was better tolerated.NCT01288820.

View Article: PubMed Central - PubMed

Affiliation: Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.

ABSTRACT

Background: A high prevalence of chloroquine-resistant Plasmodium vivax in Indonesia has shifted first-line treatment to artemisinin-based combination therapies, combined with primaquine (PQ) for radical cure. Which combination is most effective and safe remains to be established.

Methods: We conducted a prospective open-label randomized comparison of 14 days of PQ (0.25 mg base/kg) plus either artesunate-amodiaquine (AAQ + PQ) or dihydroartemisinin-piperaquine (DHP + PQ) for the treatment of uncomplicated monoinfection P. vivax malaria in North Sumatera, Indonesia. Patients were randomized and treatments were given without prior testing for G6PD status. The primary outcome was parasitological failure at day 42. Patients were followed up to 1 year.

Results: Between December 2010 and April 2012, 331 patients were included. After treatment with AAQ + PQ, recurrent infection occurred in 0 of 167 patients within 42 days and in 15 of 130 (11.5%; 95% confidence interval [CI], 6.6%-18.3%) within a year. With DHP + PQ, this was 1 of 164 (0.6%; 95% CI, 0.01%-3.4%) and 13 of 143 (9.1%; 95% CI, 4.9%-15.0%), respectively (P > .2). Intravascular hemolysis occurred in 5 patients, of which 3 males were hemizygous for the G6PD-Mahidol mutation. Minor adverse events were more frequent with AAQ + PQ.

Conclusions: In North Sumatera, Indonesia, AAQ and DHP, both combined with PQ, were effective for blood-stage parasite clearance of uncomplicated P. vivax malaria. Both treatments were safe, but DHP + PQ was better tolerated.

Clinical trials registration: NCT01288820.

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Related in: MedlinePlus

Study flowchart. Abbreviations: P.f., Plasmodium falciparum; SAE, severe adverse event.
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JIT407F1: Study flowchart. Abbreviations: P.f., Plasmodium falciparum; SAE, severe adverse event.

Mentions: Between December 2010 and April 2012, 3168 patients were screened, of whom 331 were enrolled in the study. A total of 167 patients were treated with AAQ + PQ and 164 with DHP + PQ (Figure 1). Baseline characteristics were similar between treatment arms (Table 1). Follow-up until day 42 was achieved for 138 of 167 (83%) patients treated with AAQ + PQ and 151 of 164 (91%) with DHP + PQ. One-year follow-up was completed in 130 of 167 (78%) patients treated with AAQ + PQ and 143 of 164 (87%) with DHP + PQ. The median number of missed visits per patient completing 1 year of follow-up was 1 (range, 0–9) for both treatment arms.Table 1.


A randomized comparison of dihydroartemisinin-piperaquine and artesunate-amodiaquine combined with primaquine for radical treatment of vivax malaria in Sumatera, Indonesia.

Pasaribu AP, Chokejindachai W, Sirivichayakul C, Tanomsing N, Chavez I, Tjitra E, Pasaribu S, Imwong M, White NJ, Dondorp AM - J. Infect. Dis. (2013)

Study flowchart. Abbreviations: P.f., Plasmodium falciparum; SAE, severe adverse event.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3814843&req=5

JIT407F1: Study flowchart. Abbreviations: P.f., Plasmodium falciparum; SAE, severe adverse event.
Mentions: Between December 2010 and April 2012, 3168 patients were screened, of whom 331 were enrolled in the study. A total of 167 patients were treated with AAQ + PQ and 164 with DHP + PQ (Figure 1). Baseline characteristics were similar between treatment arms (Table 1). Follow-up until day 42 was achieved for 138 of 167 (83%) patients treated with AAQ + PQ and 151 of 164 (91%) with DHP + PQ. One-year follow-up was completed in 130 of 167 (78%) patients treated with AAQ + PQ and 143 of 164 (87%) with DHP + PQ. The median number of missed visits per patient completing 1 year of follow-up was 1 (range, 0–9) for both treatment arms.Table 1.

Bottom Line: Which combination is most effective and safe remains to be established.Both treatments were safe, but DHP + PQ was better tolerated.NCT01288820.

View Article: PubMed Central - PubMed

Affiliation: Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.

ABSTRACT

Background: A high prevalence of chloroquine-resistant Plasmodium vivax in Indonesia has shifted first-line treatment to artemisinin-based combination therapies, combined with primaquine (PQ) for radical cure. Which combination is most effective and safe remains to be established.

Methods: We conducted a prospective open-label randomized comparison of 14 days of PQ (0.25 mg base/kg) plus either artesunate-amodiaquine (AAQ + PQ) or dihydroartemisinin-piperaquine (DHP + PQ) for the treatment of uncomplicated monoinfection P. vivax malaria in North Sumatera, Indonesia. Patients were randomized and treatments were given without prior testing for G6PD status. The primary outcome was parasitological failure at day 42. Patients were followed up to 1 year.

Results: Between December 2010 and April 2012, 331 patients were included. After treatment with AAQ + PQ, recurrent infection occurred in 0 of 167 patients within 42 days and in 15 of 130 (11.5%; 95% confidence interval [CI], 6.6%-18.3%) within a year. With DHP + PQ, this was 1 of 164 (0.6%; 95% CI, 0.01%-3.4%) and 13 of 143 (9.1%; 95% CI, 4.9%-15.0%), respectively (P > .2). Intravascular hemolysis occurred in 5 patients, of which 3 males were hemizygous for the G6PD-Mahidol mutation. Minor adverse events were more frequent with AAQ + PQ.

Conclusions: In North Sumatera, Indonesia, AAQ and DHP, both combined with PQ, were effective for blood-stage parasite clearance of uncomplicated P. vivax malaria. Both treatments were safe, but DHP + PQ was better tolerated.

Clinical trials registration: NCT01288820.

Show MeSH
Related in: MedlinePlus