To Evaluate Current Efficacy of Antimalarials Used in Timika, Papua, Indonesia
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|ClinicalTrials.gov Identifier: NCT00157859|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
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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 or disease||Intervention/treatment||Phase|
|Falciparum Malaria Vivax Malaria||Drug: Chloroquine and sulphadoxine-pyrimethamine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||April 2004|
|Study Completion Date :||September 2004|
- • 42 day cure rate; corrected for reinfection by PCR genotyping.
- • Overall Cure Rate at Day 42
- • 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)
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|Ages Eligible for Study:||12 Months and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
-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
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%
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157859
|SP9 & SP12 Public Health- Malaria control clinics|
|Timika, Papua, Indonesia|
|Principal Investigator:||Emiliana Tjitre, PhD||National Institute of Health Research and Development, Ministry of Health Republic of Indonesia|
|Other Study ID Numbers:||
Wellcome Trust ME028458MES
|First Posted:||September 12, 2005 Key Record Dates|
|Last Update Posted:||September 12, 2005|
|Last Verified:||September 2005|
Vector Borne Diseases
Fanasil, pyrimethamine drug combination
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary