A Randomised Trial of Artekin and Artesunate & Amodiaquine for Uncomplicated Malaria in Timika, Papua, Indonesia.

Malaria, Falciparum Clinical Trial

Official title:

A Randomized Trial to Compare the Efficacy of Artekin and Amodiaquine Plus Artesunate for the Treatment of Acute Falciparum and Vivax Malaria in Timika, Papua

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157885
• Other study ID #: Timika_AMT
• Secondary ID: Welcome Trust ME
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: June 23, 2006
• Start date: July 2005
• Est. completion date: December 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

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 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 5kg.

• Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).

• Fever (axillary temperature >37.5oC) 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

• 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

• Malaria
• Malaria, Falciparum
• Malaria, Vivax

Intervention

Drug:
• Amodiaquine plus artesunate; Artekin

Locations

Country	Name	City	State
Indonesia	SP9 & SP12 Public Health & Malaria Control 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 day 42 cure rate (incorporating early and late treatment failures)
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