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

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

September 7, 2005

Start Date ^ICMJE

April 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

• 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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Falciparum Malaria
Vivax Malaria

Intervention ^ICMJE

Drug: Chloroquine and sulphadoxine-pyrimethamine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

September 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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%

Gender

Both

Ages

12 Months and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Indonesia

Administrative Information

NCT ID ^ICMJE

NCT00157859

Responsible Party

Study ID Numbers ^ICMJE

Timika_FP_VP, Wellcome Trust ME028458MES

Study Sponsor ^ICMJE

Menzies School of Health Research

Collaborators ^ICMJE

Wellcome Trust
National Health and Medical Research Council, Australia
NIHRD

Investigators ^ICMJE

Principal Investigator:

Emiliana Tjitre, PhD

NIHRD

Information Provided By

Menzies School of Health Research

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP