A phase III clinical trial of alpha, beta-arteether injection 150 mg/ml in patients of P falciparum malaria.

Abstract

The aim of study was to evaluate efficacy and safety of alpha, beta-arteether injection 150 mg/ml by performing a phase III, multicentre, open label, and single treatment study in patients with P falciparum malaria. A total of 145 patients with P falciparum malaria were screened to achieve patient pool of 101 subjects based on inclusion and exclusion criteria, from which 100 patients completed the study successfully. Mean cure rate was calculated as primary efficacy parameter, while mean parasite clearance time (hours) and mean fever clearance time (hours) were calculated as secondary efficacy parameters, to evaluate efficacy of alpha, beta-arteether injection 150 mg/ml. Safety evaluation was measured by observing and monitoring adverse events, clinical examination, assessment of vitals and haematology laboratory parameters. Statistical analysis was performed with 5% level of significance. Mean cure rate, mean parasite clearance time (hours) and mean fever clearance time (hours) were 99.01%, 24.72 +/- 0.41 hours and 46.86 +/- 0.97 hours respectively. A total of 6 patients were observed with pain at injection site out of 101 enrolled patients. There were no clinically significant vitals and haematology changes. There were no abnormal posttreatment values observed. The study confirmed that alpha, gamma-arteether injection 150 mg/ml is highly effective in treatment of P falciparum malaria.

• Authors: Akhil Mukim, Mahesh Shukla, Jigar Patel, Hiren Patel, Shardhul Naik, Nilay Pandyas, Khyati Sanghani
• Journal: Journal of the Indian Medical Association (J Indian Med Assoc) Vol. 109 Issue 8 Pg. 597-9 (Aug 2011) ISSN: 0019-5847 [Print] India
• PMID: 22315875 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study)

Chemical References

• Antimalarials
• Artemisinins
• artemotil

Topics

• Adult
• Antimalarials (therapeutic use)
• Artemisinins (therapeutic use)
• Female
• Humans
• Malaria, Falciparum (drug therapy)
• Male