Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-05 @ 6:04 PM
Study NCT ID:
NCT03923803
Status:
UNKNOWN
Last Update Posted:
2019-04-23
First Post:
2019-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Values of C-reactive Protein and Procalcitonin in Predicting Bacterial Infection in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-18', 'studyFirstSubmitDate': '2019-04-18', 'studyFirstSubmitQcDate': '2019-04-18', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The level of C-reactive protein between Infection and Non-infectious inflammatory response in acute exacerbations of Chronic obstructive pulmonary disease patients', 'timeFrame': '24 hours', 'description': 'Patients will be classified into cases with Infection or non-infectious inflammatory response according to the level of C-reactive protein'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease is a serious disease . Exacerbations of Chronic obstructive pulmonary disease is an acute worsening condition of Chronic obstructive pulmonary disease, which always accompanied by clinical symptoms such as, shortness of breath and increased production of sputum. Respiratory infection (bacteria or viruses or mixed) is thought to be the main cause in most exacerbations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with acutely exacerbated chronic obstructive pulmonary disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients admitted to the hospital\n\nExclusion Criteria:\n\n* patients with malignancies\n* patients with other systemic infection'}, 'identificationModule': {'nctId': 'NCT03923803', 'briefTitle': 'Diagnostic Values of C-reactive Protein and Procalcitonin in Predicting Bacterial Infection in Acute Exacerbations of Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Diagnostic Values of C-reactive Protein and Procalcitonin in Predicting Bacterial Infection in Acute Exacerbations of Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'CRPPC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic obstructive pulmonary disease', 'description': 'patients with acutely exacerbated Chronic obstructive pulmonary disease admitted in chest department Assiut university hospital ,30 patients who revealed sputum culture and inflammatory markers suggesting infection exacerbation will be followed up', 'interventionNames': ['Diagnostic Test: C- reactive protein', 'Diagnostic Test: Pro calcitonin']}], 'interventions': [{'name': 'C- reactive protein', 'type': 'DIAGNOSTIC_TEST', 'description': 'the measurement will be done by chemileumeniscence', 'armGroupLabels': ['Chronic obstructive pulmonary disease']}, {'name': 'Pro calcitonin', 'type': 'DIAGNOSTIC_TEST', 'description': 'the measurement will be done by chemileumeniscence', 'armGroupLabels': ['Chronic obstructive pulmonary disease']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hanan Omar, MD', 'role': 'CONTACT', 'email': 'hananomar1962@gmail.com', 'phone': '01223971654'}, {'name': 'Zeinab Ahmed, MD', 'role': 'CONTACT', 'email': 'zeinabdoctor@yahoo.com', 'phone': '01003233267'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Doha Ismail Moussa', 'investigatorAffiliation': 'Assiut University'}}}}