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| Name | Class |
|---|---|
| Ministry of Health, Uganda | OTHER_GOV |
| Uganda Malaria Surveillance Project | OTHER |
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We will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.
This study will be designed as an open randomized effectiveness study assessing the parasitological and clinical cure rates and adherence to oral quinine monotherapy in comparison to artemether-Lumefantrine. We will also describe some of the adverse events to the two drugs.The measurements will include age, sex, weight, hemoglobin levels on days 0, 7, 14 and 28, parasite density on days 0, 7, 14 and 28 and clinical examination findings. Adverse events will also be documented
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.Oral quinine | Experimental | Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days |
|
| 2. Coartem | Active Comparator | Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| artemether-lumefantrine | Drug | Tablets taken twice daily for 3 days according to weight based guidelines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Fever clearance time assessed by self report. 2. Hemoglobin changes on day 0, 7, 14 and 28. 3. Safety profiles. 4. Adherence: measured by patient report and pill count on day 3 for the artemether-Lumefantrine group and day 7 for the quinine group. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Achan, MMed | Contact | +256-772-410183 | achanj@yahoo.co.uk | |
| Daniel Kyabayinze, MSc | Contact | +256-772-744066 | d.kyabayinze@malariaconsortium.org |
| Name | Affiliation | Role |
|---|---|---|
| Ambrose O Talisuna, PhD | Ministry of Health, Uganda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mulago National Referral Hospital | Recruiting | Kampala | Central Region | 256 | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15569777 | Background | Fogg C, Bajunirwe F, Piola P, Biraro S, Checchi F, Kiguli J, Namiiro P, Musabe J, Kyomugisha A, Guthmann JP. Adherence to a six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in Uganda. Am J Trop Med Hyg. 2004 Nov;71(5):525-30. | |
| 10770766 | Background | de Vries PJ, Bich NN, Van Thien H, Hung LN, Anh TK, Kager PA, Heisterkamp SH. Combinations of artemisinin and quinine for uncomplicated falciparum malaria: efficacy and pharmacodynamics. Antimicrob Agents Chemother. 2000 May;44(5):1302-8. doi: 10.1128/AAC.44.5.1302-1308.2000. |
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| ID | Term |
|---|---|
| D000077611 | Artemether, Lumefantrine Drug Combination |
| D011803 | Quinine |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
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| Oral quinine | Drug | Quinine tablets given at 10mg/kg 8 hourly for 7 days |
|
| 19622553 | Derived | Achan J, Tibenderana JK, Kyabayinze D, Wabwire Mangen F, Kamya MR, Dorsey G, D'Alessandro U, Rosenthal PJ, Talisuna AO. Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial. BMJ. 2009 Jul 21;339:b2763. doi: 10.1136/bmj.b2763. |
| D007287 |
| Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D002930 | Cinchona Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |