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

Lung Infection Clinical Trial

— PROPAGE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02173613
• Other study ID #: 1120
• Status: Terminated
• Phase: N/A
• Start date: August 2012
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Lung Infection

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of antibiotic therapy		Success of antibiotic therapy within 45 days of inclusion