A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia.

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (>10kg).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menzies School of Health Research
• Collaborators: National Health and Medical Research Council, Australia; National Institute of Health Research and Development, Ministry of Health Republic of Indonesia; Wellcome Trust
• Treatments: Artemether-lumefantrine combination

Criteria

Inclusion Criteria:

• Male and female patients at least one 1year of age and weighing more than 10kg.

• Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).

• Fever (axillary temperature >37.5C) or history of fever in the last 48 hours.

• Able to participate in the trial and comply with the clinical trial protocol

• Written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent

Exclusion Criteria:

• Pregnancy or lactation

• Inability to tolerate oral treatment

• Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment (See Appendix II)

• Known hypersensitivity or allergy to artemisinin derivatives

• Serious underlying disease (cardiac, renal or hepatic)

• Parasitaemia >4%