Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00157833
Other study ID # TIMIKA_FC
Secondary ID
Status Completed
Phase N/A
First received September 7, 2005
Last updated June 23, 2006
Start date July 2004
Est. completion date August 2005

Study information

Verified date June 2006
Source Menzies School of Health Research
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research Council
Study type Interventional

Clinical Trial 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).


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 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).


Recruitment information / eligibility

Status Completed
Enrollment 750
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Months and older
Eligibility 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%

Study Design

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


Intervention

Drug:
Artekin / Coartemther


Locations

Country Name City State
Indonesia SP9 and SP12 Malaria-Public Health Clinics Timika Papua

Sponsors (4)

Lead Sponsor Collaborator
Menzies School of Health Research National Health and Medical Research Council, Australia, National Institute of Health Research and Development (NIHRD), Indonesia, Wellcome Trust

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Cure Rate at Day 42
Secondary Day 42 P.falciparum cure rate corrected for reinfection by PCR genotyping
Secondary Day 42 P.vivax cure rate
Secondary Overall day 28 cure rate for P.falciparum
Secondary Proportion of patients aparasitaemic on Days 1 and 2
Secondary Haematological recovery
Secondary Gametocyte Carriage during follow up
See also
  Status Clinical Trial Phase
Completed NCT01625871 - Artemether/Lumefantrine and Vivax Malaria Phase 3
Completed NCT02876549 - G6PD Assessment Before Primaquine for Radical Treatment of Vivax Malaria Phase 4
Completed NCT01218932 - Pharmacokinetic Study of Primaquine and Chloroquine in Healthy Subjects Phase 1
Recruiting NCT04228315 - Biomarkers of P. Vivax Relapse N/A
Completed NCT02118090 - Assessment of Plasmodium Vivax Chloroquine Resistance in Cambodia: Phase 4
Completed NCT01074905 - Study on the Treatment of Vivax Malaria Phase 3
Completed NCT04222088 - TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014
Completed NCT01546961 - Chloroquine Population Pharmacokinetics in Pre and Post-partum Women N/A
Completed NCT00158548 - ACT With Chloroquine, Amodiaquine & Sulphadoxine-pyrimethamine in Pakistan Phase 3
Completed NCT00682578 - A Comparative Study of Artekin With Standard Malarial Treatment Regimes in Afghanistan Phase 3
Active, not recruiting NCT03529396 - Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients Phase 2
Recruiting NCT05874271 - Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea N/A
Completed NCT05958797 - TES of Chloroquine for Pv in the Philippines in 2016
Completed NCT01716260 - Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan N/A
Completed NCT01288820 - Study of ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria Phase 3
Completed NCT01640574 - Comparison Between 7 and 14 Day Primaquine Combined With Dihydroartemisinin-piperaquine or 3 Day Chloroquine Radical Cure of P. Vivax (BPD) Phase 3
Completed NCT01076868 - Incidence of Vivax Along the Thai Burma Border N/A
Completed NCT00158561 - Chlorproguanil/Dapsone Compared With Chloroquine and SP for Vivax Malaria Phase 3
Completed NCT01780753 - Primaquine Pharmacokinetics in Lactating Women and Their Infants Phase 1
Completed NCT06044805 - Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax Phase 4