Arterolane and Piperaquine Vs. Artemether and Lumefantrine in Uncomplicated Malaria: A Randomized Study in Nigeria.

IF 4.3 2区医学 Q1 INFECTIOUS DISEASES

International Journal of Infectious Diseases Pub Date : 2025-09-29 DOI:10.1016/j.ijid.2025.108084

Olufunsho Awodele, Ibrahim Sebutu Bello, Babatunde Abdulmajeed Akodu, Abdulakeem Ayanleye Ahmed, Sikiru Usman, Rahman Ayodele Bolarinwa, Akinwumi Akinyede, Hameed Adewale Adelabu, Emmanuel Oluwatimilehin Akande, Jayanta Dey, Vinay Kudrigikar, P Sameer Rao, Suyog Mehta

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引用次数: 0

Abstract

Objective: To compare the efficacy and safety of Arterolane maleate-Piperaquine phosphate (AMP) and Artemether-lumefantrine (AL) in Nigerian patients with acute, uncomplicated Plasmodium falciparum malaria.

Methods: This phase IV, randomized, multicenter, open-label, active-controlled study included patients aged 12-65 years with acute symptomatic, uncomplicated P. falciparum malaria. A total of 350 patients were randomized (1:1) to Test group [AMP (150 mg+750 mg) once daily] or Comparator group [AL (80 mg+480 mg) twice daily] for 3 consecutive days. The primary endpoint was polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) on Day 28. Secondary endpoints included PCR-corrected ACPR (Day 42), PCR-uncorrected ACPR (Days 28 and 42), fever clearance time (FCT), and parasite clearance time (PCT).

Results: PCR-corrected ACPR was 100% on Day 28 and sustained till Day 42 in both groups. PCR-uncorrected ACPR rates were comparable in both groups (AMP: 98.2%, AL: 99.4% on Day 28, p=0.352; AMP: 98.2%, AL: 98.8% on Day 42, p=0.674). No significant differences in FCT and PCT were observed between the groups. No drug-related adverse events (AEs) or severe AEs were reported.

Conclusion: Once-daily dosing of AMP demonstrates comparable efficacy and safety to standard twice-daily dosing of AL in the treatment of uncomplicated P. falciparum malaria.

Trial id: Pan African Clinical Trials Registry - PACTR202305878745601 (prospectively registered on 22^nd May 2023), URL: pactr.samrc.ac.za/Search.aspx.

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在尼日利亚的一项随机研究中，动脉素和哌喹与蒿甲醚和氨苯曲明治疗无并发症疟疾。

目的：比较马来动脉烷-磷酸哌喹（AMP）与蒿甲醚-氨苯曲明（AL）治疗尼日利亚急性、无并发症恶性疟原虫疟疾的疗效和安全性。方法：这项随机、多中心、开放标签、主动对照的IV期研究纳入了12-65岁急性症状、无并发症恶性疟原虫疟疾患者。350例患者按1:1的比例随机分为试验组[AMP （150 mg+750 mg）每日1次]或比较组[AL （80 mg+480 mg）每日2次]，连续3天。主要终点是第28天的聚合酶链反应（PCR）校正的充分临床和寄生虫学反应（ACPR）。次要终点包括pcr校正的ACPR（第42天）、pcr未校正的ACPR（第28天和第42天）、发热清除时间（FCT）和寄生虫清除时间（PCT）。结果：两组患者第28天pcr校正的ACPR均为100%，持续至第42天。两组未经pcr校正的ACPR率具有可比性（AMP: 98.2%, AL: 99.4%，第28天，p=0.352; AMP: 98.2%, AL: 98.8%，第42天，p=0.674）。两组间FCT和PCT无显著差异。无药物相关不良事件（ae）或严重ae报告。结论：在治疗无并发症恶性疟原虫疟疾方面，每日一次剂量的AMP与标准每日两次剂量的AL具有相当的疗效和安全性。试验id: Pan African Clinical Trials Registry - PACTR202305878745601（预期于2023年5月22日注册），URL: pactr.samrc.ac.za/Search.aspx。

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来源期刊

International Journal of Infectious Diseases 医学-传染病学

CiteScore

18.90

自引率

2.40%

发文量

1020

审稿时长

30 days

期刊介绍： International Journal of Infectious Diseases (IJID) Publisher: International Society for Infectious Diseases Publication Frequency: Monthly Type: Peer-reviewed, Open Access Scope: Publishes original clinical and laboratory-based research. Reports clinical trials, reviews, and some case reports. Focuses on epidemiology, clinical diagnosis, treatment, and control of infectious diseases. Emphasizes diseases common in under-resourced countries.