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

Study Overview
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Brief Summary
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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).

Detailed Description
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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 chloroquine and sulfadoxine-pyrimethamine resistant strains of P. falciparum. High levels of chloroquine resistance to P.vivax has also emerged in the eastern provinces. This trial sets out to assess two fixed dose artemisinin combination regimens: artekin (DHA-Piperaquine) and coartemether (artemether-lumefantrine) against both P.falciparum and P. vivax and their safety profiles. Patients who present to an established rural outpatient clinic in Timika, Papua with symptoms of acute, uncomplicated infection with P. falciparum, P.vivax or both species, will after laboratory confirmation of the diagnosis and having given informed consent to participate in the trial, be enrolled in the study. Drug administration will be supervised once per day. Patients will be treated as out-patients and then seen daily for the first week until aparasitaemic and thereafter at weekly visits to the clinic. The data used from this trial will be used to make a public health decision to determine a suitable alternative first line antimalarial in the Timika region. In order to ensure that the data gathered will be relevant to the clinical setting in which the drugs will be used, drug administration of medication will be deliberately designed to mimic conditions that will be experienced with widespread deployment (eg once daily supervision).

Official Title
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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

Conditions
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Falciparum Malaria, Vivax Malaria

Intervention / Treatment
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* Drug: Artekin / Coartemther


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Artekin / Coartemther|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Cure Rate at Day 42 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 
| Gametocyte Carriage during follow up |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coartemether, Artekin, Papua, Uncomplicated malaria