Phase
Condition
Soft Tissue Infections
Treatment
N/AClinical Study ID
Ages 18-90 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with sepsis and suspected bloodstream infection
- Be ≥ 18 years old and ≤ 90 years old
- Adults receiving IV antibiotic therapy
- Increase of at least two points of the Sequential Organ Failure Assessment (SOFA)score
- Subjects that presents Procalcitonin (PCT) levels > 0,5 ng/mL
Exclusion
Exclusion Criteria:
- Subject is currently participating in another clinical investigation
- Pregnant or nursing subjects and those who plan pregnancy during the clinicalinvestigation follow-up period
- Presence of comorbid conditions, or other medical, social, or psychological conditionsthat, in the investigator's opinion, could limit the subject's ability to participatein the clinical investigation or to comply with follow-up requirements, or impact thescientific soundness of the clinical investigation results
- The first dose of the current antibiotic therapy was > 24 h before screening
- Have Child-Pugh Class C cirrhosis
- Have platelet count < 30.000/uL
- Contraindications for heparin sodium for injection
- Subjects demonstrating any contraindication for this treatment as described in the IFU
Study Design
Study Description
Connect with a study center
Medical University of Innsbruck
Innsbruck,
AustriaSite Not Available
Middelheim Hospital
Antwerp,
BelgiumActive - Recruiting
Hôpital Erasme
Brussels,
BelgiumSite Not Available
CHU Bocage Central
Dijon,
FranceSite Not Available
Hospices Civils de Lyon
Lyon,
FranceActive - Recruiting
Nouvel Hopital Civil
Strasbourg,
FranceSite Not Available
Klinikum Aschaffenburg-Alzenau
Aschaffenburg,
GermanySite Not Available
Vivantes Klinikum Neukölln
Berlin,
GermanySite Not Available
Städtisches Klinikum Braunschweig GmbH
Braunschweig,
GermanyActive - Recruiting
Universität Witten-Herdecke
Cologne,
GermanyActive - Recruiting
Universitätsklinikum Essen (AöR)
Essen,
GermanyActive - Recruiting
University Hospital Frankfurt
Frankfurt,
GermanyActive - Recruiting
Universitätsmedizin Greifswald
Greifswald,
GermanySite Not Available
Asklepios Hospital St. Georg
Hamburg,
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover,
GermanySite Not Available
Universität Rostock
Rostock,
GermanyActive - Recruiting
Azienda Usl Toscana Centro
Florence,
ItalyActive - Recruiting
University Hospital, Pisa
Pisa,
ItalySite Not Available
A.Gemelli University Hospital
Roma,
ItalySite Not Available
Ziekenhuis Gelderse Vallei
Ede,
NetherlandsSite Not Available
Medisch Spectrum Twente
Enschede,
NetherlandsActive - Recruiting
Jagiellonia University
Kraków,
PolandActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona,
SpainSite Not Available
Hospital Clinico San Carlos
Madrid,
SpainSite Not Available
Royal Surrey NHS Foundation Trust
London,
United KingdomActive - Recruiting
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