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| Name | Class |
|---|---|
| National Institute of Health Research and Development, Ministry of Health Republic of Indonesia | OTHER |
| National Health and Medical Research Council, Australia | OTHER |
| Wellcome Trust | OTHER |
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).
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artekin / Coartemther | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Cure Rate at Day 42 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ric N Price | Menzies School of Health Research | Principal Investigator |
| Emiliana Tjitra | National Institute of Health Research and Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SP9 and SP12 Malaria-Public Health Clinics | Timika | Special Region of Papua | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17336652 | Derived | 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. |
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D016780 | Malaria, Vivax |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| Proportion of patients aparasitaemic on Days 1 and 2 |
| Haematological recovery |
| Gametocyte Carriage during follow up |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |