A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia.
A Randomized Trial to Determine the Efficacy and Safety of Coartemether and Artekin for the Treatment of Acute Falciparum and Vivax Malaria in Timika, Papua
1 other identifier
interventional
750
1 country
1
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 of acute, uncomplicated falciparum and vivax malaria in adults and children (\>10kg).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedJune 26, 2006
June 1, 2006
September 7, 2005
June 23, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Cure Rate at Day 42
Secondary Outcomes (6)
Day 42 P.falciparum cure rate corrected for reinfection by PCR genotyping
Day 42 P.vivax cure rate
Overall day 28 cure rate for P.falciparum
Proportion of patients aparasitaemic on Days 1 and 2
Haematological recovery
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SP9 and SP12 Malaria-Public Health Clinics
Timika, Special Region of Papua, Indonesia
Related Publications (1)
Ratcliff A, Siswantoro H, Kenangalem E, Maristela R, Wuwung RM, Laihad F, Ebsworth EP, Anstey NM, Tjitra E, Price RN. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. Lancet. 2007 Mar 3;369(9563):757-765. doi: 10.1016/S0140-6736(07)60160-3.
PMID: 17336652DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ric N Price
Menzies School of Health Research
- PRINCIPAL INVESTIGATOR
Emiliana Tjitra
National Institute of Health Research and Development
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
July 1, 2004
Study Completion
August 1, 2005
Last Updated
June 26, 2006
Record last verified: 2006-06