Clinical trial NCT01723644: Clinical Reassessment Versus Procalcitonin in Order to Shorten Antibiotic Duration in Community-acquired Pneumonia
Official title: CLINPCT Study: Clinical Reassessment Versus Procalcitonin-guided Algorithm in Order to Reduce Antibiotic Consumption in Community-acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: antibiotherapy, community acquired pneumonia, procalcitonin guided guidelines, clinical reassessment
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-11-08
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion criteria

* written informed consent
* age ≥ 18 years
* admittance from the community or a nursing home with the main diagnosis of community-acquired pneumonia justifying urgent antibiotherapy prescription, hospitalization for at least 6 hours after randomization and chest radiograph compatible with the diagnosis of CAP( Community acquired pneumonia )

Exclusion criteria

* the inability to give written informed consent
* hospitalization \>24 hours
* aspiration pneumonia
* nosocomial pneumonia
* purulent pleurisy
* exacerbation of COPD (chronic obstructive pulmonary disease)
* neutropenia (\<1G/L cells)
* chronic infection with current antibiotherapy
* antibiotherapy before admission for the current infection
* immunosuppression (including prolonged corticotherapy (10 mg of prednisone per day for at least one month)
* active neoplastic disease, organ transplant, pregnancy, HIV diagnosis with a CD4 count\<200 cells/μL.

Primary outcomes:
measure: duration of antibiotic therapy expressed in days of therapy
timeFrame: Between Day 1 and Day 30
Secondary outcomes:
measure: clinical success at Day 30
timeFrame: Day 30
Other outcomes:
Locations:
city: Agen
country: France
facility: University hospital of Agen
city: Angers
country: France
facility: University Hospital of Angers
city: Brest
country: France
facility: University Hospital of Brest
city: Clermont Ferrand
country: France
facility: University Hospital of Clermont-Ferrand
city: Grenoble
country: France
facility: University Hospital of Grenoble
city: La Roche sur Yon
country: France
facility: CHD Vendée
city: Lille
country: France
facility: University Hospital of Lille
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: University Hospital of Bichat Paris
city: Paris
country: France
facility: University Hospital of Bobigny Paris
city: Paris
country: France
facility: University Hospital of Hôtel-Dieu Paris
city: Paris
country: France
facility: University Hospital of Saint Antoine Paris
city: Rennes
country: France
facility: University Hospital of Rennes
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: Nantes University Hospital
name: Emmanuel Montassier
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montassier E, Javaudin F, Moustafa F, Nandjou D, Maignan M, Hardouin JB, Annoot C, Ogielska M, Orer PL, Schotte T, Bouget J, Agha Babaei S, Raynal PA, Eche A, Duc AT, Cojocaru RA, Benaouicha N, Potel G, Batard E, Talan DA. Guideline-Based Clinical Assessment Versus Procalcitonin-Guided Antibiotic Use in Pneumonia: A Pragmatic Randomized Trial. Ann Emerg Med. 2019 Oct;74(4):580-591. doi: 10.1016/j.annemergmed.2019.02.025. Epub 2019 Apr 11.