Safety and Efficacy of Procalcitonin Guided Antibiotic Therapy in Adult Intensive Care Units (ICU's)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1575 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a randomized controlled trial comparing standard-of-care therapy of infections in critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics consumption) and safety (mortality).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00987818

Sepsis Intensive Care

WITHDRAWN NA

Procalcitonin to Guide Antibiotic Stop in Neurocritical Care Patients.

NCT03683693

Sepsis

UNKNOWN NA

Procalcitonin to Shorten Antibiotics Duration in ICU Patients

NCT01379547

Sepsis

UNKNOWN PHASE3

Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit

NCT03440918

Sepsis Procalcitonin Antimicrobial Stewardship

COMPLETED NA

Short-course Antimicrobial Therapy in Sepsis

NCT02899143

Infection Sepsis Severe Sepsis +1 more

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Antibiotics are prescribed widely in intensive care units and are linked with high costs and the occurence of antimicrobial (multi)resistance. The optimal duration of antibiotic treatment is poorly known and often based on consensus guidelines.

SAPS is a multicenter, prospective, randomized, controlled open-label trial evaluating the equivalence/efficacy and safety of procalcitonin-guided treatment of infections in ICU patients versus a standard-of-care approach.

All patients that are admitted to the ICU and for whom systemic antibiotics are prescribed for presumed or proven bacterial infections are eligible for this trial. Patients will be randomized and stratified according to clinical diagnosis of severe sepsis and septic shock. Any patient over the age of 18, admitted to the ICU and receiving antibiotics for an assumed infection can be enrolled into this trial. Informed consent has to be obtained in writing from the patient of his/her relatives prior to inclusion. In the intervention group daily procalcitonin levels be performed and will generate a non-binding stopping advice when predefined stopping-rules have been reached. The ultimate decision to stop antibiotics will be at the discretion of the physician in both groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis Severe Sepsis Septic Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

procalcitonin-guidance

A daily advise to continue or stop antibiotics based on the measurement of the biomarker procalcitonin

Group Type ACTIVE_COMPARATOR

procalcitonin-guidance

Intervention Type OTHER

If procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued.

standard-of-care

standard-of-care treatment of ICU infections based upon consensus guidelines and expert opinion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

procalcitonin-guidance

If procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age over 18 years old
* receiving antibiotics for no more than 24 hours for an assumed or proven infection
* Informed consent

Exclusion Criteria

* Failure to obtain written consent to participate
* Patients receiving prolonged antibiotic therapies (\> 3 weeks, e.g. endocarditis, cerebral/hepatic abscess)
* Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasma gondii, Plasmodium spp.)
* Patients infected with Mycobacterium tuberculosis
* Patients entering the ICU for post-operative observation and/or on antibiotic prophylaxis with an estimated length of stay less then 24 hrs.
* Patients suffering from cystic fibrosis
* Severely immunocompromised patients such as patients with HIV and with a CD4 count of less than 200 cells/mm, neutropenic patients (\<500 neutrophils per mL) or patients with solid organ transplantation
* Moribund patients

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No