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

Sponsor:	Menzies School of Health Research
Collaborators:	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
ClinicalTrials.gov Identifier:	NCT00157859

Purpose

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	Intervention
Falciparum Malaria Vivax Malaria	Drug: Chloroquine and sulphadoxine-pyrimethamine

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Chloroquine diphosphate Chloroquine Pyrimethamine Fansidar Sulfadoxine Chloroquine hydrochloride

U.S. FDA Resources

Further study details as provided by Menzies School of Health Research:

Primary Outcome Measures:

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

Secondary Outcome Measures:

• 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)

Estimated Enrollment:	150
Study Start Date:	April 2004
Estimated Study Completion Date:	September 2004

Eligibility

Ages Eligible for Study:	12 Months and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157859

Locations

Indonesia, Papua
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

Investigators

Principal Investigator:

Emiliana Tjitre, PhD

National Institute of Health Research and Development (NIHRD), Indonesia

More Information

No publications provided

Study ID Numbers:	Timika_FP_VP, Wellcome Trust ME028458MES
Study First Received:	September 7, 2005
Last Updated:	September 7, 2005
ClinicalTrials.gov Identifier:	NCT00157859 History of Changes
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Menzies School of Health Research:

Falciparum
Vivax
Papua
Chloroquine
Sulphadoxine-pyrimethamine

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pyrimethamine
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Malaria, Vivax
Physiological Effects of Drugs
Malaria
Renal Agents
Antimalarials
Antiparasitic Agents
Sensory System Agents
Therapeutic Uses
Parasitic Diseases
Anti-Inflammatory Agents, Non-Steroidal

Amebicides
Analgesics
Antinematodal Agents
Protozoan Infections
Sulfadoxine-pyrimethamine
Filaricides
Coccidiosis
Chloroquine
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Anthelmintics
Folic Acid Antagonists
Sulfadoxine
Pharmacologic Actions
Malaria, Falciparum

ClinicalTrials.gov processed this record on February 04, 2010