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| ID | Type | Description | Link |
|---|---|---|---|
| Wellcome Trust ME028458MES |
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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
| National Health and Medical Research Council, Australia | OTHER |
| National Institute of Health Research and Development, Ministry of Health Republic of Indonesia | OTHER |
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroquine and sulphadoxine-pyrimethamine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| • 42 day cure rate; corrected for reinfection by PCR genotyping. | ||
| • Overall Cure Rate at Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| • 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. |
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Inclusion Criteria:
-Male and female patients at least one 1year of age and weighing more than 10kg.
Exclusion Criteria:
Pregnancy or lactation
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| Name | Affiliation | Role |
|---|---|---|
| Emiliana Tjitre, PhD | National Institute of Health Research and Development, Ministry of Health Republic of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SP9 & SP12 Public Health- Malaria control clinics | Timika | Special Region of Papua | Indonesia |
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D016780 | Malaria, Vivax |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002738 | Chloroquine |
| C001205 | fanasil, pyrimethamine drug combination |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| • 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) |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D006571 | Heterocyclic Compounds |