Clinical trial NCT00157885: A Randomised Trial of Artekin and Artesunate & Amodiaquine for Uncomplicated Malaria in Timika, Papua, Indonesia.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria, Falciparum
Malaria, Vivax
Keywords: Falciparum
Vivax
Papua
Amodiaquine
Artekin
Artemisinin Combination Therapy
Dihydroartemisinin
Piperaquine
Lumefantrine
Artemether
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
Collaborators: name: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
name: Wellcome Trust
name: National Health and Medical Research Council, Australia
First posted: 2005-09-12
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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%

Primary outcomes:
measure: Overall day 42 cure rate (incorporating early and late treatment failures)
Secondary outcomes:
measure: Day 42 P.falciparum cure rate corrected for reinfection by PCR genotyping
measure: Day 42 P.vivax cure rate
measure: Overall day 28 cure rate for P.falciparum
measure: Proportion of patients aparasitaemic on Days 1 and 2
measure: Haematological recovery
measure: Gametocyte Carriage during follow up
Other outcomes:
Locations:
city: Timika
country: Indonesia
facility: SP9 & SP12 Public Health & Malaria Control Clinics
state: Papua
Study officials:
affiliation: Menzies School of Health Research
name: Ric N Price, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Health Research and Development, Jakarta, Indonesia
name: Emiliana Tjitra
role: PRINCIPAL_INVESTIGATOR
References: