Status:
COMPLETED
A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia.
Lead Sponsor:
Menzies School of Health Research
Collaborating Sponsors:
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
National Health and Medical Research Council, Australia
Conditions:
Falciparum Malaria
Vivax Malaria
Eligibility:
All Genders
12+ years
Phase:
NA
Brief 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...
Detailed Description
With the emergence of species of multi drug resistant P.falciparum across the archipelago the Indonesian Centre for Disease Control (CDC) now recommends amodiaquine plus artesunate in areas of high ch...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00157833
Start Date
July 1 2004
End Date
August 1 2005
Last Update
June 26 2006
Active Locations (1)
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1
SP9 and SP12 Malaria-Public Health Clinics
Timika, Special Region of Papua, Indonesia