An interventional study of procalcitonin in Acute Exacerbation Copd, sponsored by University Hospital, Mahdia. Status unknown at 1 site in Tunisia. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-05-13.
Sponsored by University Hospital, Mahdia · Not applicable, Interventional, and Treatment
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.
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University Hospital, Mahdia is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
participants receive systematically empiric antibiotic therapy on admission with amoxicillin- acid clavulanic or levofloxacin in case of allergy
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
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
Time frame: 28 days
Antibiotic exposure at day 90
number of days the patient received antibiotics for any infection within 90 days from the day of admission
Time frame: 90 days
Hospital readmission for another exacerbation at day 90
another readmission for another episode of COPD exacerbation within 90 days after a first discharge
Time frame: 90 days
NIV failure
clinical deterioration requiring invasive ventilation or death
Time frame: 28 days
ICU length of say (days)
number of days spent in the ICU during the index exacerbation
Time frame: 90 days
Hospital length of stay (days)
number of days spent in hospital during the index exacerbation
Time frame: 90 days
ICU mortality
Time frame: 28 days
Plan to share: No
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
University Hospital, Mahdia