NCT00987818

Trial name or title	Procalcitonin guided versus conventional antibiotic therapy in patients with sepsis in the ICU
Methods	RCT
Participants	Inclusion criteria: Patients admitted to the ICU Age > 18 years Antibiotic therapy for sepsis with a suspected or proven focus of infection Exclusion criteria: Age < 18 years Pregnancy Infection or presumed infection requiring prolonged antibiotic therapy (osteomyelitis, meningitis, endocarditis, septic arthritis, mediastinitis, tuberculosis, Pneumocystis jiroveci pneumonia, toxoplasmosis, legionellosis, listeriosis) Indication for prolonged systemic prophylactic antibiotic therapy Severe viral or parasitic infections (haemorrhagic fever, malaria) Antibiotic therapy started 48 hours before enrolment Severe immunocompromised patients (AIDS with a CD4 count < 200 cells/mm³, severe neutropenia (< 500 neutrophils/mm³), patients undergoing immunosuppressive therapy after solid organ transplantation) Patients foregoing life‐sustaining treatment
Interventions	Procalcitonin testing
Outcomes	Primary outcome measures: Duration of antibiotic therapy (time frame: 28 days) (designated as safety issue: Yes) Secondary outcome measures: 28‐day mortality (time frame: 28 days) (designated as safety issue: Yes)
Starting date	Unclear
Contact information	Responsible Party: HJ van Leeuwen, MD PhD, Alysis Zorggroep, Rijnstate Hospital
Notes	Quote: "The adequacy of early empiric antimicrobial therapy is an important factor in determining the outcome in patients with severe sepsis. The duration of adequate antibiotic therapy in these patients however is less clear. Duration of antibiotic therapy in patients with sepsis in the ICU based on inflammatory markers has not been extensively studied. Procalcitonin (procalcitonin) 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. This study will examine the effect of procalcitonin guided antibiotic therapy compared with conventional antibiotic therapy on treatment duration in patients with sepsis admitted to the ICU."