To Evaluate Current Efficacy of Antimalarials Used in Timika, Papua, Indonesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00157859
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Wellcome Trust
National Health and Medical Research Council, Australia
National Institute of Health Research and Development (NIHRD), Indonesia
Information provided by:
Menzies School of Health Research

Brief Summary:

Multidrug resistant strains of P.falciparum and P.vivax are becoming increasingly prevalent in the Asia Pacific rim. To determine the efficacy of locally recommended antimalarial protocols in Papua, Indonesia, consecutive patients presenting to a rural clinic were enrolled into a prospective efficacy study. Patients with uncomplicated falciparum malaria were treated with chloroquine plus sulfadoxine-pyrimethamine and those with vivax malaria with chloroquine monotherapy. Patients failing therapy received unsupervised oral quinine +/- doxycycline for 7 days. Follow-up was continued for 42 days for falciparum malaria and 28 days for vivax malaria.

The study hypothesis was that current recommended antimalarial protocols were no longer effective.

Condition or disease Intervention/treatment Phase
Falciparum Malaria Vivax Malaria Drug: Chloroquine and sulphadoxine-pyrimethamine Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Evaluate the Efficacy of Chloroquine and SP for Acute Uncomplicated P. Falciparum and the Efficacy of Chloroquine for Acute Uncomplicated P. Vivax in the Timika Region of Papua, Indonesia.
Study Start Date : April 2004
Study Completion Date : September 2004

Primary Outcome Measures :
  1. • 42 day cure rate; corrected for reinfection by PCR genotyping.
  2. • Overall Cure Rate at Day 42

Secondary Outcome Measures :
  1. • Overall day 28 cure rate for P.falciparum. This will allow comparison with previous historical data at this time point.
  2. • Parasite reduction. Parasite reduction will be calculated at Days 1, 2 and 3 after initiation of trial treatment as percentage of parasites/uL compared to parasite density before the first dose of treatment.
  3. • Proportion of patients with a negative slide at Days 1, 2 and 3
  4. • Gametocyte Carriage. Anti-gametocyte activity will be measured by the proportion of patients with a peripheral gametocytaemia between day 7 to day 28.
  5. • Early Treatment Failure (ETF)
  6. • Late Treatment Failure (LTF)

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Ages Eligible for Study:   12 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 >37.5oC) 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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00157859

SP9 & SP12 Public Health- Malaria control clinics
Timika, Papua, Indonesia
Sponsors and Collaborators
Menzies School of Health Research
Wellcome Trust
National Health and Medical Research Council, Australia
National Institute of Health Research and Development (NIHRD), Indonesia
Principal Investigator: Emiliana Tjitre, PhD National Institute of Health Research and Development (NIHRD), Indonesia Identifier: NCT00157859     History of Changes
Other Study ID Numbers: Timika_FP_VP
Wellcome Trust ME028458MES
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 2005
Last Verified: September 2005

Keywords provided by Menzies School of Health Research:

Additional relevant MeSH terms:
Malaria, Falciparum
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Chloroquine diphosphate
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antinematodal Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary