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

Vivax Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157833
• Other study ID #: TIMIKA_FC
• 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
• 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

Related Conditions & MeSH terms

• Falciparum Malaria
• Malaria
• Malaria, Falciparum
• Malaria, Vivax
• Vivax Malaria

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