Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
759 participants
INTERVENTIONAL
2015-03-31
2018-04-14
Brief Summary
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Procalcitonin-guided arm: a procalcitonin level (cutoff 0.2 ng/ml) will be used to support decision on antibiotic therapy initiation.
Standard of care arm: the decision on antibiotic therapy will be based on the physicians intent to treat.
The patients will be followed up 30 and 90 days after randomization to evaluate the survival status, re-hospitalizations and further antibiotic therapies.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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PCT-guided
Blood samples are taken on day 0 and day 1 of the study. Procalcitonin (PCT) is measured and used support the decision on antibiotic therapy.
PCT levels above 0.2 ng/ml: antibiotic therapy is recommended PCT levels equal/below 0.2 ng/ml: antibiotic therapy is not recommended
Procalcitonin
Procalcitonin guided antibiotic therapy
Standard of Care
Blood samples are taken on day 0 and day 1 and stored for later analysis. The investigator treats the patients according to standard of care.
No interventions assigned to this group
Interventions
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Procalcitonin
Procalcitonin guided antibiotic therapy
Eligibility Criteria
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Inclusion Criteria
2. Suspected or known heart failure
3. midregional pro atrial natriuretic peptide (MR-proANP)\>300 pmol/L, brain natriuretic peptid (BNP) \>350 ng/ml or N-terminal of the prohormone brain natriuretic peptide (NT-proBNP)\>1800 ng/l
4. Patient has given written Informed Consent within study timelines to allow antibiotic therapy within 8 hours
5. Adult patients (i.e. \>18 years of age)
6. Hospitalization for at least 1 overnight stay planned
Exclusion Criteria
2. Trauma related shortness of breath
3. Patient diagnosed with lung or thyroid cancer
4. Known terminal disease with life expectancy of less than 6 months, e.g. advanced metastasized cancer disease
5. Organ transplant requiring immunosuppression
6. Abdominal, vascular or thorax surgery within the last 30 days
7. End stage/advanced heart failure - defined by planned heart transplantation, or cardiogenic shock
8. Female patients who have given birth within 3 months before study enrolment
9. Current use of antibiotics or requirement of immediate antibiotic therapy before randomization and measurement of Procalcitonin
10. End stage renal failure requiring dialysis
11. Patient is not willing, or it is not possible or advisable for the patient, to follow the study schedule, including antibiotic therapy and 90 days follow up
12. Patient has already participated in the clinical trial previously
13. Pregnant or lactating women
14. Patients who are institutionalized by official or judicial order
15. Dependants of the sponsor, the contract research organization (CRO), the study site or the investigator
18 Years
ALL
No
Sponsors
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Brahms AG
INDUSTRY
Responsible Party
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Principal Investigators
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Alan Maisel, MD
Role: PRINCIPAL_INVESTIGATOR
University of California-San Diego/VA San Diego Healthcare System
Martin Möckel, MD
Role: PRINCIPAL_INVESTIGATOR
university hospital Charitè Berlin
Locations
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Aalborg Sygehus
Aalborg, , Denmark
Herlev Hospital
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Kerckhoff-Klinik
Bad Nauheim, , Germany
Charite Universitätsmedizin Berlin - CCM
Berlin, , Germany
Charite Universitätmedizin Berlin - CVK
Berlin, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Klinikum Frankfurt Höchst GmbH
Frankfurt am Main, , Germany
Universitätsmedizin Göttingen
Göttingen, , Germany
Medizinische Universitätsklinik Heidelberg - Medizinische Klinik III
Heidelberg, , Germany
Universitäres Herzzentrum Lübeck
Lübeck, , Germany
Klinikum Nürnberg Nord
Nuremberg, , Germany
University Medical Center Groningen
Groningen, , Netherlands
Maastricht UMC+
Maastricht, , Netherlands
Hospital Clinico San Carlos
Madrid, , Spain
Countries
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Other Identifiers
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IMPACT-EU
Identifier Type: -
Identifier Source: org_study_id
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