Status:
COMPLETED
To Evaluate Current Efficacy of Antimalarials Used in Timika, Papua, Indonesia
Lead Sponsor:
Menzies School of Health Research
Collaborating Sponsors:
Wellcome Trust
National Health and Medical Research Council, Australia
Conditions:
Falciparum Malaria
Vivax Malaria
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
Multidrug resistant strains of P.falciparum and P.vivax are becoming increasingly prevalent in the Asia Pacific rim. To determine the efficacy of locally recommended antimalarial protocols in Papua, I...
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 \>37.5oC) 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
- -Known hypersensitivity or allergy to artemisinin derivatives
- -Serious underlying disease (cardiac, renal or hepatic)
- -Parasitaemia \>4%
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00157859
Start Date
April 1 2004
End Date
September 1 2004
Last Update
September 12 2005
Active Locations (1)
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1
SP9 & SP12 Public Health- Malaria control clinics
Timika, Special Region of Papua, Indonesia