Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157833
Status:
COMPLETED
Last Update Posted:
2006-06-26
First Post:
2005-09-07
Brief Title:
A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua Indonesia
Sponsor:
Menzies School of Health Research
Organization:
Menzies School of Health Research
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
With the emergence of species of multi drug resistant Pfalciparum 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 Pvivax 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 Pfalciparum 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 Pvivax 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
This trial sets out to assess two fixed dose artemisinin combination regimens artekin DHA-Piperaquine and coartemether artemether-lumefantrine against both Pfalciparum 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 Pvivax 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None