Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD
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|ClinicalTrials.gov Identifier: NCT03440060|
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Exacerbation Copd||Diagnostic Test: procalcitonin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- 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
- NIV failure [ Time Frame: 28 days ]clinical deterioration requiring invasive ventilation or death
- ICU length of say (days) [ Time Frame: 90 days ]number of days spent in the ICU during the index exacerbation
- Hospital length of stay (days) [ Time Frame: 90 days ]number of days spent in hospital during the index exacerbation
- ICU mortality [ Time Frame: 28 days ]
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 ClinicalTrials.gov identifier (NCT number): NCT03440060
|Mahdia, Tunisia, 5100|
|Contact: Nejla Tilouche, MD 0021623277911 firstname.lastname@example.org|