Status:
TERMINATED
Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
Lead Sponsor:
Modus Therapeutics AB
Collaborating Sponsors:
University of Oxford
Conditions:
Malaria, Falciparum
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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-mala...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01442168
Start Date
September 1 2011
End Date
January 1 2014
Last Update
August 19 2014
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Mae Ramat Hospital
Mae Ramat, Changwat Tak, Thailand
2
Maesot General hospital
Mae Sot, Changwat Tak, Thailand
3
Hospital for Tropical Diseases
Bangkok, Thailand