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

NCT00987818 | Withdrawn

• 1 other identifier: 630-190809
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Intensive Care

Keywords

Biomarkers; Antibiotic therapy

Outcome Measures

Primary Outcomes (1)

• duration of antibiotic therapy

  28 days

Secondary Outcomes (1)

• 28 day mortality

  28 days

Study Arms (2)

PCT guided antibiotic therapy

EXPERIMENTAL

Other: Procalcitonin measurement

Standard antibiotic therapy

PLACEBO COMPARATOR

Other: Procalcitonin measurement

Interventions

Procalcitonin measurement OTHER

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

PCT guided antibiotic therapy; Standard antibiotic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the ICU
• Age \> 18 years
• Antibiotic therapy for sepsis with a suspected or proven focus of infection

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Stichting Vrienden van het Alysis Leerhuis: collaborator

Study Sites (1)

Alysis Zorggroep, Rijnstate Hospital

Arnhem, Gelderland, 6800TA, Netherlands

Location

MeSH Terms

Conditions

Sepsis

Interventions

Procalcitonin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcitonin; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Protein Precursors; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: October 1, 2009
• Last Updated: September 2, 2015

Record last verified: 2012-12

Locations

NL (1)