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

Community-acquired Pneumonia Clinical Trial

— CLINPCT  

Official title:

CLINPCT Study: Clinical Reassessment Versus Procalcitonin-guided Algorithm in Order to Reduce Antibiotic Consumption in Community-acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723644
• Other study ID #: RC12_0151
• Status: Completed
• Phase: N/A
• First received: November 6, 2012
• Last updated: May 29, 2017
• Start date: October 2012
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: May 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Other:
• the clinical reassessment arm
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
• the procalcitonin arm
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.

Locations

Country	Name	City	State
France	University hospital of Agen	Agen
France	University Hospital of Angers	Angers
France	University Hospital of Brest	Brest
France	University Hospital of Clermont-Ferrand	Clermont Ferrand
France	University Hospital of Grenoble	Grenoble
France	CHD Vendée	La Roche sur Yon
France	University Hospital of Lille	Lille
France	CHU de Nantes	Nantes
France	University Hospital of Bichat Paris	Paris
France	University Hospital of Bobigny Paris	Paris
France	University Hospital of Hôtel-Dieu Paris	Paris
France	University Hospital of Saint Antoine Paris	Paris
France	University Hospital of Rennes	Rennes
France	University Hospital of Strasbourg	Strasbourg
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of antibiotic therapy expressed in days of therapy	antibiotic duration is defined as all antibiotherapy prescribed for a community acquired pneumonia during the 30 day following period Safety Issue: Yes	Between Day 1 and Day 30
Secondary	clinical success at 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.	Day 30