Clinical Reassessment Versus Procalcitonin in Order to Shorten Antibiotic Duration in Community-acquired Pneumonia (CLINPCT)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Community-acquired Pneumonia

Treatments: Other: the procalcitonin arm; Other: the clinical reassessment arm

Study type: Interventional

Funder types: Other

Identifiers

NCT01723644

RC12_0151

Details and patient eligibility

About

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.

Enrollment: 286 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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286 participants in 2 patient groups

PCT guidance

Other group

Description:

Group of patient " Procalcitonin " where the initiation and the stop of the antibiotic treatment are made according to a strategy guided by the PCT

Treatment:

Other: the procalcitonin arm

clinical reassessment

Other group

Description:

Group of patient where the initiation and the stop of the antibiotic treatment make following on clinical criteria and paraclinic not including the PCT.

Treatment:

Other: the clinical reassessment arm