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

Sponsor
University of Lausanne Hospitals (Other)
Overall Status
Completed
CT.gov ID
NCT01155739
Collaborator
(none)
162
Enrollment
1
Location
60
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective randomized trial

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    162 participants
    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
    Study Start Date :
    Jun 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2014
    Actual Study Completion Date :
    Jun 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. antibiotic treatment length, hospitalisation length without antibiotic, infection recurrence, antibiotic cost [at one month and during hospital stay]

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicolas DEMARTINES, professor of surgery, University of Lausanne Hospitals
    ClinicalTrials.gov Identifier:
    NCT01155739
    Other Study ID Numbers:
    • 141/08, Propéritonite
    First Posted:
    Jul 2, 2010
    Last Update Posted:
    Dec 19, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:
    Peritonitis

    Study Results

    No Results Posted as of Dec 19, 2014