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Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03440060
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : May 13, 2019
Information provided by (Responsible Party):
Nejla Tilouche, University Hospital, Mahdia

Brief Summary:
This study assess whether a procalcitonin guided antibiotic therapy can reduce significantly unnecessary antibiotic prescription during severe exacerbation of COPD requiring mechanical ventilation without compromising patients' outcome. The first group of patients will receive systematically empiric antibiotic therapy and the second group will receive antibiotics only if procalcitonin value is at or greater than 0.25 ng/ml.

Condition or disease Intervention/treatment Phase
Acute Exacerbation Copd Diagnostic Test: procalcitonin Not Applicable

Detailed Description:

Recently, procalcitonin gained interest as the most reliable biomarker in predicting bacterial origin in low respiratory tract infections and sepsis.

Procalcitonin was shown to be non-inferior to standard guidelines in guiding antibiotic therapy during COPD exacerbation, without worsening patients' outcomes, and with a significant reduction in antibiotic exposure.

Its use to guide antibiotic treatment during COPD exacerbation may be more challenging because of the frequent colonization of the airways in patients with COPD, and thus it needs further evaluation.

Additionally, until today, no interventional studies evaluating procalcitonin protocol have been conducted in ventilated COPD patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD Requiring Mechanical Ventilation: a Controlled Randomized Trial
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
No Intervention: standard group
participants receive systematically empiric antibiotic therapy on admission with amoxicillin- acid clavulanic or levofloxacin in case of allergy
Active Comparator: Procalcitonin group
participants receive antibiotics only if the procalcitonin value is at or greater than 0.25 ng/ml
Diagnostic Test: procalcitonin
procalcitonin value will be obtained within 24 hours after ICU admission in both groups and will be taken into account in the procalcitonin group only

Primary Outcome Measures :
  1. time to recovery [ Time Frame: 28 days ]
    defined by resolution of symptoms ( cough, sputum purulence and respiratory rate less than 25 breath per minute) and NIV withdrawal (normal pH for 24 consecutive hours after stopping NIV), for patients with home NIV investigators retain stabilization after returning to the same number of hours of NIV before current exacerbation and pH normalization for 24 consecutive hours

Secondary Outcome Measures :
  1. Antibiotic exposure at day 90 [ Time Frame: 90 days ]
    number of days the patient received antibiotics for any infection within 90 days from the day of admission

  2. Hospital readmission for another exacerbation at day 90 [ Time Frame: 90 days ]
    another readmission for another episode of COPD exacerbation within 90 days after a first discharge

  3. NIV failure [ Time Frame: 28 days ]
    clinical deterioration requiring invasive ventilation or death

  4. ICU length of say (days) [ Time Frame: 90 days ]
    number of days spent in the ICU during the index exacerbation

  5. Hospital length of stay (days) [ Time Frame: 90 days ]
    number of days spent in hospital during the index exacerbation

  6. ICU mortality [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients > 40 years old who consent to the study protocol
  • COPD diagnosis based on GOLD guidelines

Exclusion Criteria:

  • Patients who did not consent
  • Asthma
  • Malignancy
  • Immunocompromised
  • Survival for at least 1 year is unlikely
  • Patients already enrolled in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03440060

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Tilouche Nejla Recruiting
Mahdia, Tunisia, 5100
Contact: Nejla Tilouche, MD    0021623277911   
Sponsors and Collaborators
University Hospital, Mahdia

Publications of Results:
Other Publications:
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Responsible Party: Nejla Tilouche, principal investigator, University Hospital, Mahdia Identifier: NCT03440060     History of Changes
Other Study ID Numbers: 301401
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nejla Tilouche, University Hospital, Mahdia:
mechanical ventilation
COPD exacerbation
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents