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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01155739
First received: July 23, 2009
Last updated: December 18, 2014
Last verified: December 2014
  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:


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 ]

Enrollment: 162
Study Start Date: June 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Switzerland
University Hospital of Lausanne
Lausanne, Switzerland, 1011
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: December 18, 2014
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Peritonitis
Digestive System Diseases
Infection
Intraabdominal Infections
Peritoneal Diseases

ClinicalTrials.gov processed this record on February 27, 2015