Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT03440060
Status:
UNKNOWN
Last Update Posted:
2019-05-13
First Post:
2018-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-10', 'studyFirstSubmitDate': '2018-02-06', 'studyFirstSubmitQcDate': '2018-02-13', 'lastUpdatePostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to recovery', 'timeFrame': '28 days', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Antibiotic exposure at day 90', 'timeFrame': '90 days', 'description': 'number of days the patient received antibiotics for any infection within 90 days from the day of admission'}, {'measure': 'Hospital readmission for another exacerbation at day 90', 'timeFrame': '90 days', 'description': 'another readmission for another episode of COPD exacerbation within 90 days after a first discharge'}, {'measure': 'NIV failure', 'timeFrame': '28 days', 'description': 'clinical deterioration requiring invasive ventilation or death'}, {'measure': 'ICU length of say (days)', 'timeFrame': '90 days', 'description': 'number of days spent in the ICU during the index exacerbation'}, {'measure': 'Hospital length of stay (days)', 'timeFrame': '90 days', 'description': 'number of days spent in hospital during the index exacerbation'}, {'measure': 'ICU mortality', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['procalcitonin', 'mechanical ventilation', 'COPD exacerbation'], 'conditions': ['Acute Exacerbation Copd']}, 'referencesModule': {'references': [{'pmid': '28143877', 'type': 'BACKGROUND', '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):160073. doi: 10.1183/16000617.0073-2016. Print 2017 Jan.'}, {'pmid': '14987884', 'type': 'RESULT', 'citation': 'Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Muller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7. doi: 10.1016/S0140-6736(04)15591-8.'}, {'pmid': '19738090', 'type': 'RESULT', '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 procalcitonin-based guidelines vs standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. JAMA. 2009 Sep 9;302(10):1059-66. doi: 10.1001/jama.2009.1297.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "Recently, procalcitonin gained interest as the most reliable biomarker in predicting bacterial origin in low respiratory tract infections and sepsis.\n\nProcalcitonin 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.\n\nIts 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.\n\nAdditionally, until today, no interventional studies evaluating procalcitonin protocol have been conducted in ventilated COPD patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 40 years old who consent to the study protocol\n* COPD diagnosis based on GOLD guidelines\n\nExclusion Criteria:\n\n* Patients who did not consent\n* Asthma\n* Malignancy\n* Immunocompromised\n* Survival for at least 1 year is unlikely\n* Patients already enrolled in this study'}, 'identificationModule': {'nctId': 'NCT03440060', 'briefTitle': 'Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Mahdia'}, 'officialTitle': 'Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD Requiring Mechanical Ventilation: a Controlled Randomized Trial', 'orgStudyIdInfo': {'id': '301401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard group', 'description': 'participants receive systematically empiric antibiotic therapy on admission with amoxicillin- acid clavulanic or levofloxacin in case of allergy'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Procalcitonin group', 'description': 'participants receive antibiotics only if the procalcitonin value is at or greater than 0.25 ng/ml', 'interventionNames': ['Diagnostic Test: procalcitonin']}], 'interventions': [{'name': 'procalcitonin', 'type': 'DIAGNOSTIC_TEST', 'description': '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', 'armGroupLabels': ['Procalcitonin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5100', 'city': 'Mahdia', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Nejla Tilouche, MD', 'role': 'CONTACT', 'email': 'tilouche.nejla@gmail.com', 'phone': '0021623277911'}], 'facility': 'Tilouche Nejla', 'geoPoint': {'lat': 35.50472, 'lon': 11.06222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Mahdia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Nejla Tilouche', 'investigatorAffiliation': 'University Hospital, Mahdia'}}}}