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At 75% patient completion overall mortality was much lower than expected and without significant difference at day 90. No chance to reach the primary endpoint.
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Patients presenting to the Emergency Department with shortness of breath and (suspected) heart failure will be screened and randomized to either a standard of care or a procalcitonin-guided arm.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCT-guided | Experimental | 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 |
|
| Standard of Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procalcitonin | Other | Procalcitonin guided antibiotic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality | 30 days | |
| all-cause hospital readmission | 30 days | |
| Number of patients with diagnosis of pneumonia during index hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Maisel, MD | University of California-San Diego/VA San Diego Healthcare System | Principal Investigator |
| Martin Möckel, MD | university hospital Charitè Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Sygehus | Aalborg | 9000 | Denmark | |||
| Herlev Hospital |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007239 | Infections |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077740 | Procalcitonin |
| ID | Term |
|---|---|
| D002116 | Calcitonin |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| participants will be followed for the duration of hospital stay, an expected average of 1 week |
| Herlev |
| 2730 |
| Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| Kerckhoff-Klinik | Bad Nauheim | 61231 | Germany |
| Charite Universitätsmedizin Berlin - CCM | Berlin | 10117 | Germany |
| Charite Universitätmedizin Berlin - CVK | Berlin | 13353 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | 60596 | Germany |
| Klinikum Frankfurt Höchst GmbH | Frankfurt am Main | 65929 | Germany |
| Universitätsmedizin Göttingen | Göttingen | 37075 | Germany |
| Medizinische Universitätsklinik Heidelberg - Medizinische Klinik III | Heidelberg | 69120 | Germany |
| Universitäres Herzzentrum Lübeck | Lübeck | 23538 | Germany |
| Klinikum Nürnberg Nord | Nuremberg | 90419 | Germany |
| University Medical Center Groningen | Groningen | 9713 | Netherlands |
| Maastricht UMC+ | Maastricht | 6229 | Netherlands |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D011506 | Proteins |