Clinical Trials Logo

Clinical Trial 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 daily for 3 days.


Clinical Trial 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 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 the efficacy of artekin and amodiaquine plus artesunate and artekin 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. 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00157885
Study type Interventional
Source Menzies School of Health Research
Contact
Status Completed
Phase N/A
Start date July 2005
Completion date December 2005

See also
  Status Clinical Trial Phase
Completed NCT02329301 - Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia N/A
Recruiting NCT01944189 - Artemether/ Lumefantrine: A Study of the Effect of Local Food on Pharmacokinetics and Population Pharmacokinetics Phase 4
Terminated NCT01442168 - Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria Phase 1/Phase 2
Completed NCT01325974 - Time to Become Negative of Three Rapid Diagnostic Tests for Malaria N/A
Completed NCT00375128 - Sporozoite Challenge of Polyprotein Vaccinees Phase 1/Phase 2
Terminated NCT00374205 - Randomized Trial on Effectiveness of ACTs in Ghana Phase 4
Completed NCT04609098 - Single Low Dose Tafenoquine to Reduce P. Falciparum Transmission in Mali (NECTAR2) Phase 2
Completed NCT02851108 - Methylene Blue Against Falciparum Malaria in Burkina Faso Phase 2
Terminated NCT02281344 - MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants Phase 1
Completed NCT02434952 - Safety and Tolerability of Low Dose Primaquine Phase 4
Completed NCT01213966 - Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection Phase 2
Completed NCT00479206 - Artemisinin Resistance in Cambodia N/A
Completed NCT00126906 - Prevention of Malaria During Pregnancy Using Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: Malawi N/A
Completed NCT01019408 - Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan Phase 4
Completed NCT00529867 - Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria Phase 4
Completed NCT00137553 - The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children Phase 4
Completed NCT02637128 - In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated P. Falciparum Malaria Phase 4
Completed NCT01222962 - Food Interaction Study on the Pharmacokinetics of Eurartesimâ„¢ (DHA and PQP)in Healthy Male Adult Volunteers Phase 1
Unknown status NCT00152204 - The Community Effectiveness of IPTi in Southern Tanzania Phase 3
Terminated NCT00084240 - Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia Phase 2/Phase 3