Procalcitonin as a Marker for the Length of Antibiotic Treatment in Peritonitis and Intra-abdominal Infections

December 18, 2014 updated by: Nicolas DEMARTINES, University of Lausanne Hospitals

Etude Prospective Sur l'Impact de l'Utilisation de la Procalcitonine Dans l'évaluation de la Poursuite ou de l'arrêt du Traitement Antibiotique Empirique Lors de péritonites et d'Infections Intra-abdominales

Procalcitonin level used for determining length of antibiotic treatment in peritonitis and intra-abdominal infections. Hypothesis is that length of antibiotic use can be shortened by this method.

Study Overview

Status

Completed

Conditions

Detailed Description

Prospective randomized trial

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1011
        • University Hospital of Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

hospitalized patients with SIRS due to peritonitis or intra-abdominal infections

Description

Inclusion Criteria:

  • More than 18 yo
  • Patient requiring surgery for peritonitis or intra-abdominal infection following: perforation, necrosis, previous operation...
  • Mannheim Peritonitis score > 14
  • SIRS present
  • Probability of survival > 72h
  • Informed consent by patient/relatives

Exclusion Criteria:

  • No SIRS
  • Long date corticoid treatment
  • Immunosuppression
  • Thyroid medullary carcinoma
  • Anaphylactic shock
  • Acute hepatic deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
procalcitonine monitoring
PCT group: antibiotic use is tailored by serum procalcitonin values, determined every 48houres.
control group
control group: antibiotic use and length of treatment as defined by guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
antibiotic treatment length, hospitalisation length without antibiotic, infection recurrence, antibiotic cost
Time Frame: at one month and during hospital stay
at one month and during hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Investigators

  • Principal Investigator: Steve Aellen, MD, Department of visceral surgery, university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 1, 2010

First Posted (Estimate)

July 2, 2010

Study Record Updates

Last Update Posted (Estimate)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 18, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 141/08, Propéritonite

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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