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
| Autor: | Deo Nidhi Mishra, Alok Chandra Bhardwaj, Rashmi Ranjan Das, Anupkumar R. Anvikar, Reena Choudhury, Neena Valecha, Madhukar Pandey, Neeraj Jauhri, Amit Nasa, Bina Srivastava, Raj Kamal Bahl, Vimal Kant Goyal, Ajay Punj, Santhosh T Soans, Rajinder K. Jalali, Sanjay K Sharma, Omesh Khurana, Bantwal Shantharam Baliga, Arjun Roy, Susanta K. Ghosh |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Population Fixed-dose combination Plasmodium vivax arterolane maleate Infectious and parasitic diseases RC109-216 act chemistry.chemical_compound Chloroquine Piperaquine Internal medicine parasitic diseases medicine plasmodium vivax Arterolane education pct education.field_of_study Intention-to-treat analysis biology business.industry General Medicine biology.organism_classification Chloroquine Phosphate Infectious Diseases pediatric chemistry Parasitology business medicine.drug |
| Zdroj: | Journal of Vector Borne Diseases, Vol 57, Iss 3, Pp 213-220 (2020) |
| ISSN: | 0972-9062 |
| Popis: | 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 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. |
| Databáze: | OpenAIRE |
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