Reduction the Duration of Antibiotic Therapy in the Elderly (PROPAGE) (PROPAGE)

April 25, 2022 updated by: University Hospital, Grenoble

Reduction of the Duration of Antibiotic Guided by Procalcitonin in Infections Lungs of Hospitalized Elderly: a Randomized

The main objective is to evaluate the interest of the repeated measurement of procalcitonin in patients with pulmonary infection to reduce the duration of antibiotic therapy in comparison with a conventional clinical strategy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

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

  • France
    • Rhone Alpes
      • Grenoble, Rhone Alpes, France, 38000
        • University Hospital Grenoble

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

80 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 80 years
  • Started antibiotics for a chest infection
  • Procalcitonin performed J0 antibiotic treatment
  • Person affiliated to the social security

Exclusion Criteria:

  • Patients with a documented infection with germs after Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis
  • Patients with a documented infection with a virus or parasite (eg hemorrhagic fever, malaria)
  • Patients with endovascular infection associated (endocarditis, pacemaker. Intravascular catheter)
  • Patients with lung abscess associated upon entry Patients with a chronic infection associated
  • Patients with severe immunosuppression (HIV or transplant)
  • Palliative patient
  • Death within 24 hours of admission to nursing units.
  • Presence of antibiotic treatment for chronic infection.
  • Patient under guardianship, curatorship or any other administrative or judicial action or deprivation of the right or freedom
  • Patients hospitalized without their consent

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

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Procalcitonine
every 2 days, they will receive the dose of PCT and decide to stop antibiotic treatment according to the algorithm 2. They will notify the results of clinical evaluations in the electronics and all adverse event report forms.
Other: procalcitonine

The recommendations will be based on the level of PCT: 4 levels of advice will be given:

  • It is highly recommended to stop antibiotics if PCT <0.1ng/ml, and the recommended stop if 0.1ng/ml
  • It is recommended to continue treatment if 0.25 ng / ml
  • Finally, if the initial PCT greater than 10 ng / ml, a stop will be advised in case of reduction to less than 10% of baseline level.
NO_INTERVENTION: contrôle
Only clinical reassessments will be conducted and documented. Data on antibiotic will be listed and all adverse events. Data on the PCT from D2 to D4, D6, D8 and D15 output or will not be available to the prescriber.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of antibiotic therapy
Time Frame: Success of antibiotic therapy within 45 days of inclusion
Success of antibiotic therapy within 45 days of inclusion

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Gaetan Gavazzi, University Clinic of Geriatrics Medicine, Division of Medicine multidisciplinary CHU de Grenoble,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

August 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 20, 2014

First Posted (ESTIMATE)

June 25, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1120 (Other Identifier: Ain Shams University)

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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