Adding PCT measurements to standard diagnostics to support decision making regarding initiation of antibiotics. To evaluate an advantage of PCT guided prescription of antibiotic treatment over established treatment practice with respect to 90-day…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
90-day all-cause mortality of patients (# of days from randomization)
Secondary outcome
a) 30-day all-cause mortality
b) Hospital all-cause readmission within 30 days
c) Number of patients with diagnosis of pneumonia during index hospitalization
Background summary
To evaluate an advantage of PCT guided prescription of antibiotic treatment
over established treatment practice with respect to 90-day all cause
mortality in Europe.
Study objective
Adding PCT measurements to standard diagnostics to support decision making
regarding initiation of antibiotics. To evaluate an advantage of PCT guided
prescription of antibiotic treatment over established treatment practice with
respect to 90-day all cause
mortality in Europe.
Study design
Prospective, multicentre, randomized-controlled, interventional biomarker study
Study burden and risks
Control group: no additional risks
PCT-group. Through false high or false low PCT values a wrong decision could be
made about the antibiotic therapy.
Patient with PCT above cutoff: in this group the prescription of antibiotics is
expected to be higher than the standard of care. Therefore more patients could
suffer from side effects of antibiotics.
Patients with PCT below the cutoff: In this group is expected that less
antibiotics are prescribed than according to standard of care. In previous
studies it was shown that the antibiotic treatment can be reduced through PCT
without worsening of clinical condition. However it cannot be excluded that the
treatment according to PCT could have a negative effect.
Neuendorfstr 25
Henningsdorf 16761
DE
Neuendorfstr 25
Henningsdorf 16761
DE
Listed location countries
Age
Inclusion criteria
1. Patients who present to the ED with leading symptom dyspnea
2. Suspected or known heart failure
3. MR-proANP>300 pmol/L, BNP>350 ng/ml or NT-proBNP>1800 ng/l
4. Patient has given written Informed Consent within study timelines to allow antibiotic treatment within 8 hours
5. Adult patients (i.e. >18 years of age)
6. Hospitalization for at least 1 overnight stay planned
Exclusion criteria
1. Patient participates in any other interventional clinical trial
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 HF * 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 PCT
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 CRO, the study site or the investigator
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02392689 |
| CCMO | NL54246.042.15 |