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Trial record 1 of 2 for:    19493352 [PUBMED-IDS]
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Reduction the Duration of Antibiotic Therapy in the Elderly (PROPAGE) (PROPAGE)

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ClinicalTrials.gov Identifier: NCT02173613
Recruitment Status : Unknown
Verified June 2014 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : June 25, 2014
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Infection Other: procalcitonine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Reduction of the Duration of Antibiotic Guided by Procalcitonin in Infections Lungs of Hospitalized Elderly: a Randomized
Study Start Date : August 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 <PCT <0.25 ng / ml.
  • It is recommended to continue treatment if 0.25 ng / ml <PCT 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.



Primary Outcome Measures :
  1. Duration of antibiotic therapy [ Time Frame: Success of antibiotic therapy within 45 days of inclusion ]


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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173613


Contacts
Contact: Claire Bollart 04 76 76 56 09 CBollart@chu-grenoble.fr
Contact: Fatah TIDADINI 04 76 76 50 40 FTidadini@chu-grenoble.fr

Locations
France
University Hospital Grenoble Recruiting
Grenoble, Rhone alpes, France, 38000
Contact: gaetan gavazzi, Phd    : 04.76.76.57.97    GGavazzi@chu-grenoble.fr   
Contact: fatah tidadini, ARC    04 76 76 50 40    FTidadini@chu-grenoble.fr   
Principal Investigator: Gaetan Gavazzi         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Gaetan Gavazzi University Clinic of Geriatrics Medicine, Division of Medicine multidisciplinary CHU de Grenoble,

Publications:
Polton D, Sermet C. Le vieillissement de la population va-t-il submerger le système de santé ? Bulletin Epidémiologique Hebdomadaire. 2006; 5-6:49-52.
Gaymu J. Aspects démographiques du vieillissement; Bulletin Epidémiologique Hebdomadaire. 2006; 5-6:38-9.

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02173613     History of Changes
Other Study ID Numbers: 1120
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014

Keywords provided by University Hospital, Grenoble:
infection lung elderly patients

Additional relevant MeSH terms:
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents