Status:
COMPLETED
A Randomised Trial of Artekin and Artesunate & Amodiaquine for Uncomplicated Malaria in Timika, Papua, Indonesia.
Lead Sponsor:
Menzies School of Health Research
Collaborating Sponsors:
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Wellcome Trust
Conditions:
Malaria, Falciparum
Malaria, Vivax
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
The primary aim of the comparative trial is to assess the relative safety and efficacy of two artemisinin containing regimens: amodiaquine plus artesunate (AAQ) and artekin both administered once dail...
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 5kg.
- 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 :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00157885
Start Date
July 1 2005
End Date
December 1 2005
Last Update
June 26 2006
Active Locations (1)
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1
SP9 & SP12 Public Health & Malaria Control Clinics
Timika, Special Region of Papua, Indonesia