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Sponsors and Collaborators: |
Menzies School of Health Research Wellcome Trust National Health and Medical Research Council, Australia NIHRD |
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Information provided by: | Menzies School of Health Research |
ClinicalTrials.gov Identifier: | NCT00157859 |
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 |
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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. |
Estimated Enrollment: | 150 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | September 2004 |
Ages Eligible for Study: | 12 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-Male and female patients at least one 1year of age and weighing more than 10kg.
Exclusion Criteria:
Pregnancy or lactation
Indonesia, Papua | |
SP9 & SP12 Public Health- Malaria control clinics | |
Timika, Papua, Indonesia |
Principal Investigator: | Emiliana Tjitre, PhD | NIHRD |
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 |
Falciparum Vivax Papua Chloroquine Sulphadoxine-pyrimethamine |
Folic Acid Pyrimethamine Protozoan Infections Sulfadoxine-pyrimethamine Chloroquine diphosphate Malaria, Vivax |
Chloroquine Parasitic Diseases Malaria Sulfadoxine Malaria, Falciparum |
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 |