Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dilaforette AB; Modus Therapeutics AB
• Collaborator: University of Oxford
• Treatments: Atovaquone

Criteria

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