Clinical Reassessment Versus Procalcitonin in Order to Shorten Antibiotic Duration in Community-acquired Pneumonia
- Conditions
- Community-acquired Pneumonia
- Interventions
- Other: the clinical reassessment armOther: the procalcitonin arm
- Registration Number
- NCT01723644
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial including adult patients admitted in the emergency department with community-acquired pneumonia. The objective of this clinical trial is to compare two strategies: clinical reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg, Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 286
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description clinical reassessment the clinical reassessment arm Group of patient where the initiation and the stop of the antibiotic treatment make following on clinical criteria and paraclinic not including the PCT. PCT guidance the procalcitonin arm Group of patient " Procalcitonin " where the initiation and the stop of the antibiotic treatment are made according to a strategy guided by the PCT
- Primary Outcome Measures
Name Time Method duration of antibiotic therapy expressed in days of therapy Between Day 1 and Day 30 antibiotic duration is defined as all antibiotherapy prescribed for a community acquired pneumonia during the 30 day following period Safety Issue: Yes
- Secondary Outcome Measures
Name Time Method clinical success at Day 30 Day 30 clinical success is defined as cure of the pneumonia at Day 30 Safety Issue: Clinical cure was defined as either the return to the pre-infection state (i.e. all pneumonia-related signs and symptoms had disappeared and chest X-ray findings had shown improvement) or improvement in related post-infectious stigmata, such that residual symptoms if any did not require additional treatment and were accompanied by improvement or lack of progression based on chest X-ray.
Trial Locations
- Locations (15)
University hospital of Agen
🇫🇷Agen, France
University Hospital of Grenoble
🇫🇷Grenoble, France
University Hospital of Rennes
🇫🇷Rennes, France
University Hospital of Tours
🇫🇷Tours, France
University Hospital of Bobigny Paris
🇫🇷Paris, France
CHD Vendée
🇫🇷La Roche sur Yon, France
University Hospital of Bichat Paris
🇫🇷Paris, France
University Hospital of Angers
🇫🇷Angers, France
University Hospital of Clermont-Ferrand
🇫🇷Clermont Ferrand, France
CHU de Nantes
🇫🇷Nantes, France
University Hospital of Brest
🇫🇷Brest, France
University Hospital of Lille
🇫🇷Lille, France
University Hospital of Saint Antoine Paris
🇫🇷Paris, France
University Hospital of Strasbourg
🇫🇷Strasbourg, France
University Hospital of Hôtel-Dieu Paris
🇫🇷Paris, France