Malaria, Falciparum | Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
Malaria, Falciparum research study
What is the primary objective of this study?
The purpose of this study is to determine the tolerability and pharmacokinetics of Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil® (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected erythrocyte sequestration and rosette formation. The study consists of a dose escalation part (part 1) followed by an open labelled, randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone (part 2).
Who is eligible to participate?
Inclusion Criteria: - Presence of acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of a single species (P. falciparum) - Counts of asexual forms of P. falciparum: 10 000- 100 000/ul with or without gametocytaemia - Presence of fever defined as > 38°C tympanic temperature or a history of fever within the last 24 hours Exclusion Criteria: - Mixed infection with other Plasmodium species - Any criteria of severe or complicated malaria as defined by the WHO, 2010 - Use of high doses aspirin (more than 100 mg/day) or dual anti-platelet therapy or use of heparin,Low Molecular Weight Heparin (LMWH) or warfarin - Presence of significant anemia as defined by Hb <8 g/dL or Hct < 25% - A platelet count < 50,000/μL - Presence of febrile conditions caused by diseases other than malaria
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Sevuparin sodium + atovaquone/proquanilSevuparin 4 times per day and malanil according to label
Drug:atovaquone/proquanilmalanil according to label
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Sevuparin/DF02Sevuparin/DF02 plus anti-malarial regimen (Malanil®)
ControlAnti-malarial regimen (Malanil®) alone
Start Date: September 2011
Completed Date: January 2014
Phase: Phase 1/Phase 2
Primary Outcome: Dose limiting toxicities according to specified criteria
Study sponsors, principal investigator, and references
Principal Investigator: Anna Leitgeb, PhD
Lead Sponsor: Modus Therapeutics AB
Collaborator: University of Oxford