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

• Sponsor: Rijnstate Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00987818
• Collaborator: Stichting Vrienden van het Alysis Leerhuis (Other)
• Enrollment: 0
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Intensive Care	Other: Procalcitonin measurement	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Reduction of Antibiotic Use in the ICU: Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PCT guided antibiotic therapy	Other: Procalcitonin measurement; Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.
Placebo Comparator: Standard antibiotic therapy	Other: Procalcitonin measurement; Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.

Outcome Measures

Primary Outcome Measures

1. duration of antibiotic therapy [28 days]

Secondary Outcome Measures

1. 28 day mortality [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alysis Zorggroep, Rijnstate Hospital	Arnhem	Gelderland	Netherlands	6800TA

Sponsors and Collaborators

• Rijnstate Hospital
• Stichting Vrienden van het Alysis Leerhuis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00987818
• Other Study ID Numbers: 630-190809
• First Posted: Oct 1, 2009
• Last Update Posted: Sep 2, 2015
• Last Verified: Dec 1, 2012

• Keywords provided by , ,: Biomarkers; Antibiotic therapy
• Additional relevant MeSH terms: Sepsis; Toxemia

Study Results

No Results Posted as of Sep 2, 2015