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NCT Number: NCT01723644

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

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.

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Key information

Conditions

Community-Acquired Pneumonia Community-Acquired Infections Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Agen, Agen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

the clinical reassessment arm

Other

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

Other

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.

Primary outcomes

  1. duration of antibiotic therapy expressed in days of therapy

    Time frame: 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 outcomes

  1. clinical success at Day 30

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: CLINPCT

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Nov 8, 2012
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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