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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03440060
Other study ID # 301401
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 5, 2017
Est. completion date December 31, 2020

Study information

Verified date May 2019
Source University Hospital, Mahdia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Tunisia Tilouche Nejla Mahdia

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Mahdia

Country where clinical trial is conducted

Tunisia, 

References & Publications (3)

Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Müller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lance — View Citation

Mathioudakis AG, Chatzimavridou-Grigoriadou V, Corlateanu A, Vestbo J. Procalcitonin to guide antibiotic administration in COPD exacerbations: a meta-analysis. Eur Respir Rev. 2017 Jan 31;26(143). pii: 160073. doi: 10.1183/16000617.0073-2016. Print 2017 Jan. Review. — View Citation

Schuetz P, Christ-Crain M, Thomann R, Falconnier C, Wolbers M, Widmer I, Neidert S, Fricker T, Blum C, Schild U, Regez K, Schoenenberger R, Henzen C, Bregenzer T, Hoess C, Krause M, Bucher HC, Zimmerli W, Mueller B; ProHOSP Study Group. Effect of procalci — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary time to recovery 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 28 days
Secondary Antibiotic exposure at day 90 number of days the patient received antibiotics for any infection within 90 days from the day of admission 90 days
Secondary Hospital readmission for another exacerbation at day 90 another readmission for another episode of COPD exacerbation within 90 days after a first discharge 90 days
Secondary NIV failure clinical deterioration requiring invasive ventilation or death 28 days
Secondary ICU length of say (days) number of days spent in the ICU during the index exacerbation 90 days
Secondary Hospital length of stay (days) number of days spent in hospital during the index exacerbation 90 days
Secondary ICU mortality 28 days
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