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| Tracking Information | |||||
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| 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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Chloroquine and sulphadoxine-pyrimethamine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| 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.
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Months and older | ||||
| Accepts Healthy Volunteers | No | ||||
| 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 |
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| Investigators ICMJE |
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| Information Provided By | Menzies School of Health Research | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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