Is the duration of Procalcitonin guided antibiotic therapy shorter than standard antibiotic therapy in patients with sepsis admitted to the ICU and treated with antibiotics
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
· Duration of antibiotic therapy
· Antibiotic free days
Secondary outcome
· 28 day mortality
· In hospital mortality
· ICU LOS
· Hospital LOS
· Clinical Cure
· Reoccurrence of initial infection
· Nosocomial superinfection
Background summary
The adequacy of early empiric antimicrobial therapy is an important factor in
determining the outcome in patients with severe sepsis. In hospitalized
patients with community acquired pneumonia, early administration of adequate
antimicrobial therapy determines patient outcome. The duration of adequate
antibiotic therapy in these patients however is less clear. In hospitalized
patients with mild to moderate-severe community acquired pneumonia(CAP), 3 day
antibiotic treatment is clinical as effective as 8 day treatment. Comparing 8
and 15 days of appropriate antibiotic therapy in ICU patients with ventilator
associated pneumonia (VAP) shows comparable clinical efficacy and mortality
accompanied with a significant reduction in antibiotic-free days. An antibiotic
discontinuation policy in the ICU based on predetermined criteria
(noninfectious etiology established, temperature < 38.3ºC, white cell count <10
or decreased by >25% from peak value, improvement of chest X-ray, absence of
purulent sputum, PaO2/FiO2 ratio >250) showed similar efficacy associated with
a two day reduction in antibiotic treatment. Duration of antibiotic therapy in
patients with sepsis in the ICU based on inflammatory markers has not been
extensively studied.
Procalcitonin (PCT) is an acute phase protein that has prognostic value in
critically ill patients and can be used to monitor disease activity in sepsis
and systemic inflammation. Increase in serum PCT levels is associated with a
high risk of mortality while a PCT decrease is a strong predictor of survival.
PCT guided antibiotic therapy has been shown to significantly reduce antibiotic
use in hospitalized patients with lower respiratory tract infections ,community
acquired pneumonia or sepsis without a reduction in efficacy. In patients with
sepsis there is also a significant reduction in ICU length of stay.
Cost-effectiveness of PCT guided antibiotic therapy is expected when reduction
of ICU length of stay is taken into account.
Study objective
Is the duration of Procalcitonin guided antibiotic therapy shorter than
standard antibiotic therapy in patients with sepsis admitted to the ICU and
treated with antibiotics
Study design
Monocenter prospective randomized controlled unblinded clinical trial
Intervention
PCT guided antibiotic therapy in the intervention goup, standard antibiotic
therapy in the control group
Study burden and risks
No extra burden. In the control group risk of superinfection, resistant
microorganisms, prolonged length of stay. In the intervention group disease
recurrence.
postbus 9555
6800TA, Arnhem
Nederland
postbus 9555
6800TA, Arnhem
Nederland
Listed location countries
Age
Inclusion criteria
1. Patients admitted to the ICU
2. Age >18 years
3. Antibiotic therapy for sepsis with a suspected or proven focus of infection
Exclusion criteria
1. Age <18 years
2. Pregnancy
3. Infection or presumed infection requiring prolonged antibiotic therapy (osteomyelitis, meningitis, endocarditis, septic arthritis, mediastinitis, tuberculosis, Pneumocystis jiroveci pneumonia, Toxoplasmosis, Legionellosis, Listeriosis)
4. Indication for prolonged systemic prophylactic antibiotic therapy
5. Severe viral or parasitic infections (hemorrhagic fever, malaria)
6. Antibiotic therapy started 48 hours before enrollment
7. Severe immunocompromised patients (AIDS with a CD4 count<200cells/mm3, severe neutropenia(<500 neutrophils/mm3), patients undergoing immunosuppressive therapy after solid organ transplantation)
8. Patients foregoing lifesustaining treatment.
Design
Recruitment
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 |
|---|---|
| CCMO | NL28773.000.09 |