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

Sponsors and Collaborators:	Menzies School of Health Research Wellcome Trust National Health and Medical Research Council, Australia NIHRD
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

MedlinePlus related topics: Malaria

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

U.S. FDA Resources

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.

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

NIHRD

Investigators

Principal Investigator:

Emiliana Tjitre, PhD

NIHRD

More Information

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

Keywords provided by Menzies School of Health Research:

Falciparum
Vivax
Papua
Chloroquine
Sulphadoxine-pyrimethamine

Study placed in the following topic categories:

Folic Acid
Pyrimethamine
Protozoan Infections
Sulfadoxine-pyrimethamine
Chloroquine diphosphate
Malaria, Vivax

Chloroquine
Parasitic Diseases
Malaria
Sulfadoxine
Malaria, Falciparum

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Renal Agents
Antimalarials
Antiparasitic Agents
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Amebicides

Antinematodal Agents
Coccidiosis
Filaricides
Anthelmintics
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Folic Acid Antagonists
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009