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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.
 
ClinicalTrials.gov Identifier: NCT00157859
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Sponsor:
Collaborators:
Wellcome Trust
National Health and Medical Research Council, Australia
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Information provided by:
Menzies School of Health Research

Study Description
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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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arms and Interventions
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Outcome Measures
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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)

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

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%
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00157859


Locations
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Indonesia
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, Ministry of Health Republic of Indonesia
Investigators
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Principal Investigator: Emiliana Tjitre, PhD National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
More Information
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ClinicalTrials.gov Identifier: NCT00157859    
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:
Falciparum
Vivax
Papua
Chloroquine
Sulphadoxine-pyrimethamine
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Chloroquine
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
 Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents