A Phase 3, Double-Blind, Randomized Study of Arterolane Maleate-Piperaquine Phosphate vs Artemether- Lumefantrine for Falciparum Malaria in Adolescent and Adult Patients in Asia and Africa.
In: Clinical Infectious Diseases, Jg. 62 (2016-04-15), Heft 8, S. 964-971
Online
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Zugriff:
Background. Artemisinins, which are derived from plants, are subject to risk of supply interruption due to climatic changes. Consequently, an effort to identify a new synthetic antimalarial was initiated. A fixed-dose combination of arterolane maleate (AM), a new synthetic trioxolane, with piperaquine phosphate (PQP), a long half-life bisquinoline, was evaluated in patients with uncomplicated Plasmodium falciparum malaria. Methods. In this multicenter, randomized, double-blind, comparative, parallel-group trial, 1072 patients aged 12-65 years with P. falciparum monoinfection received either AM-PQP (714 patients) once daily or artemether-lumefantrine (A-L; 358 patients) twice daily for 3 days. All patients were followed up until day 42. Results. Of the 714 patients in the AM-PQP group, 638 (89.4%) completed the study; of the 358 patients in the A-L group, 301 (84.1%) completed the study. In both groups, the polymerase chain reaction corrected adequate clinical and parasitological response (PCR-corrected ACPR) on day 28 in intent-to-treat (ITT) and per-protocol (PP) populations was 92.86% and 92.46% and 99.25% and 99.07%, respectively. The corresponding figures on day 42 in the ITT and PP populations were 90.48% and 91.34%, respectively. After adjusting for survival ITT, the PCR-corrected ACPR on day 42 was >98% in both groups. The overall incidence of adverse events was comparable. Conclusions. AM-PQP showed comparable efficacy and safety to A-L in the treatment of uncomplicated P. falciparum malaria in adolescent and adult patients. AM-PQP demonstrated high clinical and parasitological response rates as well as rapid parasite clearance. [ABSTRACT FROM AUTHOR]
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A Phase 3, Double-Blind, Randomized Study of Arterolane Maleate-Piperaquine Phosphate vs Artemether- Lumefantrine for Falciparum Malaria in Adolescent and Adult Patients in Asia and Africa.
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Autor/in / Beteiligte Person: | Toure, Offianan Andre ; Valecha, Neena ; Tshefu, Antoinette K. ; Thompson, Ricardo ; Krudsood, Srivicha ; Gaye, Oumar ; Krishnamurthy Rao, Bappanaidu Hoigegudde ; Sagara, Issaka ; Bose, Tarit Kumar ; Mohanty, Sanjib ; Rao, Ballamudi Srinivas ; Anvikar, Anupkumar R. ; Mwapasa, Victor ; Noedl, Harald ; Arora, Sudershan ; Roy, Arjun ; Iyer, Sunil S. ; Sharma, Pradeep ; Saha, Nilanjan ; Jalali, Rajinder K. |
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Zeitschrift: | Clinical Infectious Diseases, Jg. 62 (2016-04-15), Heft 8, S. 964-971 |
Veröffentlichung: | 2016 |
Medientyp: | academicJournal |
ISSN: | 1058-4838 (print) |
DOI: | 10.1093/cid/ciw029 |
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