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

NCT00157885 | Completed

• 2 other identifiers: Timika_AMTWelcome Trust ME028458MES
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria, Falciparum; Malaria, Vivax

Keywords

Falciparum; Vivax; Papua; Amodiaquine; Artekin; Artemisinin Combination Therapy; Dihydroartemisinin; Piperaquine; Lumefantrine; Artemether

Outcome Measures

Primary Outcomes (1)

• Overall day 42 cure rate (incorporating early and late treatment failures)

Secondary Outcomes (6)

• Day 42 P.falciparum cure rate corrected for reinfection by PCR genotyping

• Day 42 P.vivax cure rate

• Overall day 28 cure rate for P.falciparum

• Proportion of patients aparasitaemic on Days 1 and 2

• Haematological recovery

Interventions

Amodiaquine plus artesunate; Artekin DRUG

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Menzies School of Health Research: lead
• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia: collaborator
• Wellcome Trust: collaborator
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

SP9 & SP12 Public Health & Malaria Control Clinics

Timika, Special Region of Papua, Indonesia

Location

MeSH Terms

Conditions

Malaria, Falciparum; Malaria, Vivax

Interventions

Amodiaquine; Artesunate

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons

Study Officials

• Ric N Price, MD

  Menzies School of Health Research

  PRINCIPAL INVESTIGATOR

• Emiliana Tjitra

  National Institute of Health Research and Development, Jakarta, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2005
• Study Completion: December 1, 2005
• Last Updated: June 26, 2006

Record last verified: 2006-06

Locations

ID (1)