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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Terminated

CT.gov ID

NCT02173613

Collaborator

(none)

117

Enrollment

Location

Arms

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

117 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Duration of antibiotic therapy [Success of antibiotic therapy within 45 days of inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

80 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Grenoble	Grenoble	Rhone Alpes	France	38000

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT02173613

Other Study ID Numbers:

1120

First Posted:

Jun 25, 2014

Last Update Posted:

May 2, 2022

Last Verified:

Feb 1, 2016

Keywords provided by University Hospital, Grenoble

infection lung elderly patients

Additional relevant MeSH terms:

Infections

Study Results

No Results Posted as of May 2, 2022