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

This study is currently recruiting participants.
Verified April 2012 by University of Lausanne Hospitals
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01155739
First received: July 23, 2009
Last updated: April 21, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition
Secondary or Tertiary Peritonitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • antibiotic treatment length, hospitalisation length without antibiotic, infection recurrence, antibiotic cost [ Time Frame: at one month and during hospital stay ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 166
Study Start Date: June 2009
Estimated Study Completion Date: December 2012
Groups/Cohorts
procalcitonine monitoring
control group
control group: antibiotic use and length of treatment as defined by guidelines

Detailed Description:

Prospective randomized trial

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155739

Locations
Switzerland
University Hospital of Lausanne Recruiting
Lausanne, Switzerland, 1011
Contact: Steve Aellen, MD         steve.aellen@chuv.ch    
Principal Investigator: Steve Aellen, MD            
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Steve Aellen, MD Department of visceral surgery, university hospital
  More Information

No publications provided

Responsible Party: Nicolas DEMARTINES, professor of surgery, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01155739     History of Changes
Other Study ID Numbers: 141/08, Propéritonite
Study First Received: July 23, 2009
Last Updated: April 21, 2012
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Peritonitis
Peritoneal Diseases
Digestive System Diseases
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013