Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU

Reduction of Antibiotic Use in the ICU: Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00987818

Enrollment

Registered

2009-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2015-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care, Sepsis

Keywords

Biomarkers, Antibiotic therapy

Brief summary

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 (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. This study will examine the effect of PCT guided antibiotic therapy compared with conventional antibiotic therapy on treatment duration in patients with sepsis admitted to the ICU.

Interventions

OTHERProcalcitonin measurement

Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 (hemorrhagic fever, malaria) * Antibiotic therapy started 48 hours before enrollment * Severe immunocompromised patients (AIDS with a CD4 count \< 200cells/mm3, severe neutropenia(\<500 neutrophils/mm3), patients undergoing immunosuppressive therapy after solid organ transplantation) * Patients foregoing life sustaining treatment

Design outcomes

Primary

Measure	Time frame
duration of antibiotic therapy	28 days

Secondary

Measure	Time frame
28 day mortality	28 days

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026