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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01723644
First received: November 6, 2012
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Community-acquired Pneumonia
Other: the clinical reassessment arm
Other: the procalcitonin arm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: CLINPCT Study: Clinical Reassessment Versus Procalcitonin-guided Algorithm in Order to Reduce Antibiotic Consumption in Community-acquired Pneumonia

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • duration of antibiotic therapy expressed in days of therapy [ Time Frame: Between Day 1 and Day 30 ] [ Designated as safety issue: Yes ]
    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:
  • clinical success at Day 30 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 286
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PCT guidance
Group of patient " Procalcitonin " where the initiation and the stop of the antibiotic treatment are made according to a strategy guided by the PCT
Other: 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.
clinical reassessment
Group of patient where the initiation and the stop of the antibiotic treatment make following on clinical criteria and paraclinic not including the PCT.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723644

Contacts
Contact: Emmanuel Montassier, PH 0253482038 emmanuel.montassier@chu-nantes.fr

Locations
France
University hospital of Agen Recruiting
Agen, France
Principal Investigator: Albert Trinh-Duc, Pu-PH         
University Hospital of Angers Active, not recruiting
Angers, France
University Hospital of Brest Suspended
Brest, France
University Hospital of Clermont-Ferrand Recruiting
Clermont Ferrand, France
Principal Investigator: Jeannot Schmidt, Pu-PH         
University Hospital of Grenoble Not yet recruiting
Grenoble, France
Principal Investigator: Françoise Carpentier, PU-PH         
CHD Vendée Recruiting
La Roche sur Yon, France
Contact: Philippe Fradin, MD-PhD         
University Hospital of Lille Not yet recruiting
Lille, France
Principal Investigator: Alain Durocher, PU-PH         
CHU de Nantes Recruiting
Nantes, France
Contact: Emmanuel Montassier, PH    0253482038    emmanuel.montassier@chu-nantes.fr   
Principal Investigator: Emmanuel Montassier         
Sub-Investigator: Eric Batard, PU-PH         
University Hospital of Saint Antoine Paris Recruiting
Paris, France
Principal Investigator: Dominique Pateron, PU-PH         
University Hospital of Hôtel-Dieu Paris Active, not recruiting
Paris, France
University Hospital of Bichat Paris Active, not recruiting
Paris, France
University Hospital of Bobigny Paris Recruiting
Paris, France
Principal Investigator: Frédéric Adnet         
University Hospital of Rennes Active, not recruiting
Rennes, France
University Hospital of Strasbourg Recruiting
Strasbourg, France
Principal Investigator: BILBAULT, Pu-PH         
University Hospital of Tours Active, not recruiting
Tours, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Emmanuel Montassier CHU de Nantes
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01723644     History of Changes
Other Study ID Numbers: RC12_151
Study First Received: November 6, 2012
Last Updated: April 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
antibiotherapy, community acquired pneumonia, procalcitonin guided guidelines, clinical reassessment

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 22, 2014