Clinical trial · Observational
Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment
Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate in Treatment of Severe Malaria in Ugandan Patients
NCT01122134CI-TRIAL-00003438unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Intravenous artesunate is highly effective with rapid schizonticidal action and improved clinical outcome
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Severe Malaria | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intravenous artesunate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 20 adults with severe malaria
- description
- 20 adult patients admitted with severe malaria
- interventionNames
- Drug: intravenous artesunate
Primary outcomes (1)
- measure
- 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
- timeFrame
- 6 hours
- description
- Pharmacokinetic parameters for artesunate and dihydroartemisinin
Secondary outcomes (1)
- measure
- Time to 50% parasite clearance (PCT50)
- timeFrame
- 7 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged 18 years and above 2. With severe malaria according to the following ciriteria: 3. A positive blood smear for malaria with P. falciparum mono-infection with parasitemia \> 500 parasites/ul of blood 4. Who according to the attending physician require parenteral treatment and admission for malaria 5. Willing to participate in the study 6. Who are or whose first degree parents/caretakers are able to provide written informed consent Exclusion Criteria: 1. Patients with history of prior antimalarial use within the last 72 hours 2. Pregnant women 3. Patients with contraindications to taking the study drugs 4. Patients taking known inhibitors or inducers of cytochrome P450 -
References
Publications (1)
- DERIVEDByakika-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. PMID 22540954