Reduction the Duration of Antibiotic Therapy in the Elderly (PROPAGE)
NCT ID: NCT02173613
Last Updated: 2022-05-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
117 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-08-31
Study Completion Date
2016-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Lung Infection
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
procalcitonine
Intervention Type
OTHER
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.
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 80 years
* Started antibiotics for a chest infection
* Procalcitonin performed J0 antibiotic treatment
* Person affiliated to the social security
* 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
* 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
Minimum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Grenoble
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Gaetan Gavazzi
Role: PRINCIPAL_INVESTIGATOR
University Clinic of Geriatrics Medicine, Division of Medicine multidisciplinary CHU de Grenoble,
Locations
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University Hospital Grenoble
Grenoble, Auvergne-Rhône-Alpes, France
Site Status
Countries
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France
References
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Reference Type
DERIVED
Other Identifiers
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1120
Identifier Type: -
Identifier Source: org_study_id
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