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Intravenous artesunate is highly effective with rapid schizonticidal action and improved clinical outcome
The current first line treatment for severe malaria in Uganda is intravenous quinine with artemisinin derivatives as an alternative. Intravenous artesunate, a water soluble artemisinin derivative is more effective than quinine with faster schizonticidal action and improved clinical outcome. It is generally well tolerated and safe. This study aims is to assess the pharmacokinetics, pharmacodynamics and safety of IV artesunate in treatment of severe malaria in adults admitted to Mulago National Referral and Teaching hospital, Uganda.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 adults with severe malaria | 20 adult patients admitted with severe malaria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous artesunate | Drug | Intravenous artesunate in a dose of 2.4 mg/kg at start of treatment, 2.4 mg/kg 12 hours later and 2.4 mg/kg/day until the patient is able to tolerate oral therapy. The minimum duration of IV treatment will be 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters; total area under the plasma concentration vs. time curve (AUC) of artesunate and DHA, maximum plasma concentration (Cmax), time to attain maximum concentration, elimination half life | Pharmacokinetic parameters for artesunate and dihydroartemisinin | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to 50% parasite clearance (PCT50) | Time to 50% parasite clearance (PCT50) parasite clearance rates and clinical recovery | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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The target population for this study are patients aged 18 years and above. The accessible population will be patients of 18 years and above who present to Mulago hospital with severe malaria. The study population will include patients aged 18 years and above presenting with severe malaria, who fulfill study eligibility criteria and are enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Pauline Byakika-Kibwika, MSc, MMed | Makerere University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mulago National Referral hospital | Kampala | 256 | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22540954 | Derived | Byakika-Kibwika P, Lamorde M, Mayito J, Nabukeera L, Mayanja-Kizza H, Katabira E, Hanpithakpong W, Obua C, Pakker N, Lindegardh N, Tarning J, de Vries PJ, Merry C. Pharmacokinetics and pharmacodynamics of intravenous artesunate during severe malaria treatment in Ugandan adults. Malar J. 2012 Apr 27;11:132. doi: 10.1186/1475-2875-11-132. |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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Blood samples collected for artesunate drug assays
|
| D000079426 |
| Vector Borne Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |