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

September 7, 2005 updated by: Menzies School of Health Research

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Papua
      • Timika, Papua, Indonesia
        • SP9 & SP12 Public Health- Malaria control clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
• 42 day cure rate; corrected for reinfection by PCR genotyping.
• Overall Cure Rate at Day 42

Secondary Outcome Measures

Outcome Measure
• Overall day 28 cure rate for P.falciparum. This will allow comparison with previous historical data at this time point.
• 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.
• Proportion of patients with a negative slide at Days 1, 2 and 3
• Gametocyte Carriage. Anti-gametocyte activity will be measured by the proportion of patients with a peripheral gametocytaemia between day 7 to day 28.
• Early Treatment Failure (ETF)
• Late Treatment Failure (LTF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menzies School of Health Research

Collaborators

National Health and Medical Research Council, Australia
Wellcome Trust
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Investigators

  • Principal Investigator: Emiliana Tjitre, PhD, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2005

Last Update Submitted That Met QC Criteria

September 7, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Timika_FP_VP
  • Wellcome Trust ME028458MES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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