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RESEARCH ARTICLE
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Efficacy and safety of fixed dose combination of arterolane maleate and piperaquine phosphate in comparison with chloroquine phosphate in children with acute uncomplicated Plasmodium vivax malaria: a phase III, randomised, multicentric study


1 National Institute of Malaria Research, New Delhi, India
2 Department of Pediatrics, Panchsheel Hospital, Delhi, India
3 Nirmal Hospital, Jhansi, Uttar Pradesh, India
4 Department of Pediatrics, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India
5 MV Hospital and Research Center, Lucknow, Uttar Pradesh, India
6 Department of Pediatrics, Popular Hospital, Varanasi, Uttar Pradesh, India
7 Department of Pediatrics, Chandulal Chandrakar Memorial Medical College (CCMMC), Durg, Chhattisgarh, India
8 Department of Pediatrics, Vintage Hospital & Medical Research Centre, Goa, India
9 Department of Pediatrics, Sudbhawana Hospital, Varanasi, Uttar Pradesh, India
10 Department of Pediatrics, Kasturba Medical College and Wenlock District Govt. Hospital (KMC & WDGH), Mangalore, Karnataka, India
11 National Institute of Malaria Research Field Station, Bangalore, India
12 Department of Pediatrics, A J Institute of Medical Science & Research Centre (AJIMSRC), Mangalore, Karnataka, India, Indiaz
13 Department of Pediatrics, Marudhar Hospital, Jaipur, Rajasthan, India
14 Department of Pediatrics, Subharti Medical College and Hospital, Meerut, Uttar Pradesh, India
15 Medical Affairs & Clinical Research, Sun Pharmaceutical Industries Limited, Gurgaon, Haryana, India

Correspondence Address:
Anupkumar R Anvikar,
National Institute of Malaria Research, Sector 8 Dwarka, New Delhi
India
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0972-9062.311781

Background & objectives: In India, the burden of Plasmodium vivax malaria has been projected to be highest in some areas. This study investigated the efficacy and safety of fixed dose combination (FDC) of arterolane maleate (AM) 37.5 mg and piperaquine phosphate 187.5 mg (PQP) dispersible tablets and (not with) chloroquine in the treatment of uncomplicated vivax malaria in pediatric patients. Methods: This multicentric, open-label trial was carried out at 12 sites in India. A total of 164 patients aged 6 months to 12 years with P. vivax malaria were randomized in a ratio of 2:1 to AM-PQP (111 patients) or chloroquine (53 patients) arms. The duration of follow up was 42 days. Results: At 72 hours, the proportion of a parasitaemic and afebrile patients was 100% in both treatment arms in per protocol (PP) population, and 98.2% and 100% [95% CI: -1.8 (-6.33 to 5.08)] in AM-PQP and chloroquine (CQ) arms, respectively, in intent to treat (ITT) population. The efficacy and safety of AM-PQP was found to be comparable to chloroquine in the treatment of uncomplicated P. vivax malaria in pediatric patients. Overall, the cure rate at Day 28 and 42 was >95% for both AM-PQP or CQ. The commonly reported clinical adverse event was vomiting. No patient was discontinued for any QTc abnormality. Interpretation & conclusion: The efficacy and safety of FDC of arterolane maleate and piperaquine phosphate was found to be comparable to chloroquine for treatment of uncomplicated P. vivax malaria in pediatric patients. Clinical Trial Registration India: CTRI/2015/08/006087


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