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All Profiles
Call Senior Fellowship (SF)
Programme EDCTP1
Start Date 2011-03-14
End Date 2013-09-30
Project Code TA.2009.40200.020
Status Completed

Title

Comparison of efficacy, safety and pharmacokinetics of intravenous artesunate and intravenous quinine followed by oral artemisinin combination therapy for severe malaria treatment in Uganda AND evaluation of pharmacokinetic drug interactions of artesunate, quinine, lumefantrine and piperaquine with antiretroviral drugs

Objectives

To evaluate the effectiveness of IV artesunate plus ACT and IV quinine plus ACT as well as to study the pharmacokinetics of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) for treatment of severe malaria in adults and children in Tororo district hospital, Uganda. 1. To compare treatment outcome (measured as risk of recurrent parasitaemia and risk of recurrent symptomatic malaria) following treatment with IV quinine followed by oral ACT (Artemether-Lumefantrine or Dihydroartemisinin-piperaquine) and IV artesunate followed by oral ACT (AL or DP) for treatment of severe malaria in Ugandan patients 2. To compare parasite clearance time following treatment with IV quinine followed by oral ACT (AL or DP) and IV artesunate followed by oral ACT (AL or DP) for treatment of severe malaria in Ugandan patients 3. To investigate the pharmacokinetic parameters of IV quinine, IV artesunate, oral AL and oral DP during severe malaria treatment in Ugandan patients and correlate these with treatment outcome 4. To investigate the pharmacokinetic drug interactions of quinine, artesunate, lumefantrine and piperaquine with the antiretroviral drugs (Nevirapine, Efavirenz, Lopinavir/ritonavir) in Ugandan patients.

Host Organisation

Institution Country
Makerere University College Of Health Sciences Uganda
Makerere University Uganda

Participants

Name Institution Country
Jane Achan Makerere University Uganda
Moses R. Kamya Makerere University Uganda
Elly Katabira Makerere University Uganda
Noah Kiwanuka Makerere University Uganda
Mohammed Lamorde Makerere University Uganda
Harriet Mayanja-Kizza Makerere University Uganda
Concepta Merry Makerere University, Uganda/Trinity College, Ireland Uganda

Study Design

PK and drug interaction studies

Sites

Makerere University
Infectious Diseases Institute
Mulago Hospital

Students Supervised

Type Name Title University Start Date End Date
Masters in Medicine Afizi Kibuuka Dr Makerere University 2011 2014
Masters in Medicine Kambale Kasonia Dr Makerere University 2013 2016
Masters of Science in Clinical Epidemiology and Biostatistics Ritah Bakesiima Ms Makerere University 2015 2017

Results & Outcomes

Follow-up of 274 study participants sucessfully completed. Samples for genotyping successfully analysed at the Mulago Molecular Biology laboratory. Samples for drug assays shipped to Mahidol Clinical Pharmacology Laboratory, Thailand. Preliminary results: 1. Rate of achieving failure among patients who received IV Artesunate is higher than in patients who received IV Quinine. 2. Rate of achieving recrudescence is higher among patients who received IV Quinine, compared to those that received IV Artesurate. 3. Probability of acquiring recrudescence is highest among the patients that received IV Quinine + DP.

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