Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT04456712
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2020-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-07-20', 'releaseDate': '2020-07-06'}, {'resetDate': '2020-08-04', 'releaseDate': '2020-07-20'}, {'resetDate': '2020-09-11', 'releaseDate': '2020-08-22'}], 'estimatedResultsFirstSubmitDate': '2020-07-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D064704', 'term': 'Levofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015242', 'term': 'Ofloxacin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'fifty diabetic patients received intravenous levofloxacin 750 mg/24 hours. fifty diabetic patients received intravenous ciprofloxacin 400mg/12 hours. fifty non-diabetic patients received intravenous levofloxacin 750 mg/24 hours. fifty non-diabetic patients received intravenous ciprofloxacin 400mg/12 hours.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-30', 'studyFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2020-06-30', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of ciprofloxacin versus levofloxacin on QTc interval', 'timeFrame': 'before starting antibiotic, after 24 hours, 72 hours from the first dose and after 72 hours from antibiotic cessation', 'description': 'change in QTc interval (QTc prolongation)'}, {'measure': 'Effect of ciprofloxacin versus levofloxacin on fasting blood glucose', 'timeFrame': 'before starting antibiotic, after 24 hours, 72 hours from the first dose and after 72 hours from antibiotic cessation', 'description': 'change in fasting blood glucose (dysglycemia)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Levofloxacin, ciprofloxacin, QTc prolongation, dysglycemia.'], 'conditions': ['QTc Prolongation, Hyperglycemia, Hypoglycemia']}, 'referencesModule': {'references': [{'pmid': '31357640', 'type': 'BACKGROUND', 'citation': 'Mathews B, Thalody AA, Miraj SS, Kunhikatta V, Rao M, Saravu K. Adverse Effects of Fluoroquinolones: A Retrospective Cohort Study in a South Indian Tertiary Healthcare Facility. Antibiotics (Basel). 2019 Jul 27;8(3):104. doi: 10.3390/antibiotics8030104.'}, {'pmid': '25494485', 'type': 'BACKGROUND', 'citation': 'Lu ZK, Yuan J, Li M, Sutton SS, Rao GA, Jacob S, Bennett CL. Cardiac risks associated with antibiotics: azithromycin and levofloxacin. Expert Opin Drug Saf. 2015 Feb;14(2):295-303. doi: 10.1517/14740338.2015.989210. Epub 2014 Dec 10.'}, {'pmid': '30148925', 'type': 'BACKGROUND', 'citation': 'Granados J, Ceballos M, Amariles P. [Hypo or hyperglycemia associated with fluoroquinolone use]. Rev Med Chil. 2018 May;146(5):618-626. doi: 10.4067/s0034-98872018000500618. Spanish.'}, {'pmid': '29488552', 'type': 'BACKGROUND', 'citation': 'Gonzalez M C, Rosales C R, Pavez D, Fuenzalida LM, Soto A, Perez R, Perez J, Araos R, Pinto ME. [Safety of fluoroquinolones: risks usually forgotten for the clinician]. Rev Chilena Infectol. 2017 Dec;34(6):577-582. doi: 10.4067/S0716-10182017000600577. Spanish.'}]}, 'descriptionModule': {'briefSummary': 'To compare intravenous levofloxacin and ciprofloxacin regarding their risk on the corrected QT interval (QTc) prolongation and dysglycemia in diabetic and non-diabetic patients.', 'detailedDescription': 'Fluoroquinolones represent an important class of antibacterial drug and they are used worldwide.Fluoroquinolones are classified into generations according to the spectrum of antimicrobial activities that targeted them.Fluoroquinolones may cause several side effects as tendon rupture, central nervous toxicity, cardiovascular toxicity, gastrointestinal toxicity, phototoxicity, disrupted glucose metabolism, skin disorders and hypersensitivity. Ciprofloxacin, a second generation fluoroquinolone, is one of the most successful and widely used compounds of fluoroquinolone. On the other hand, levofloxacin is a third generation fluoroquinolone.\n\nDiabetes mellitus (DM) is chronic disease and a serious of metabolic disorder associated with the presence of hyperglycemia due to partial or complete insulin deficiency. Diabetes mellitus is a major risk factor for cardiovascular diseases.\n\nFluoroquinolone class is associated with cardiac side effects as QTc prolongation. Some agents of fluoroquinolones were withdrawn from market. However, cardiac adverse effects has been developed with fluoroquinolones still in market. Members of fluoroquinolones class have different effects on QT interval. The US FDA suggested that the risk and benefits ratio of fluoroquinolones should be taken into consideration.\n\nIn addition to hyperglycemia events are more common with fluoroquinolones than with other classes of antibiotics. The food and drug administration (FDA) confirmed the current warning that fluoroquinolones may cause decrease in blood sugar especially in diabetic patients. However, other study proved that fluoroquinolones may cause dysglycemic events in diabetic and non-diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult patient (male, female)\n* age from 18 to 70 years .\n* Be able to give an informed consent form after understanding for reasonable explanation of clinical trial's purpose, contents and characteristics of clinical drugs\n* Wiling to participate whole clinical trial periods\n\nExclusion Criteria:\n\n* Younger than 18 years or older than 70 years.\n* Has prolonged QTc before receiving therapy.\n* With a history of heart diseases.\n* Received class IA or III antiarrhythmic agents.\n* Received macrolide antibiotics.\n* With a history of quinolone allergy.\n* Pregnant and lactating women."}, 'identificationModule': {'nctId': 'NCT04456712', 'briefTitle': 'Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia in Diabetic and Non-Diabetic Patients.', 'orgStudyIdInfo': {'id': 'ciprofloxacin and levofloxacin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ciprofloxacin for diabetic patients', 'description': '50 diabetic patients received intravenous ciprofloxacin 400mg/12 hours.', 'interventionNames': ['Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution']}, {'type': 'EXPERIMENTAL', 'label': 'levofloxacin for diabetic patients', 'description': '50 diabetic patients received intravenous levofloxacin 750mg/24 hours.', 'interventionNames': ['Drug: Levofloxacin 750 MG']}, {'type': 'EXPERIMENTAL', 'label': 'ciprofloxacin for non-diabetic patients', 'description': '50 non-diabetic patients received intravenous ciprofloxacin 400mg/12 hours.', 'interventionNames': ['Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution']}, {'type': 'EXPERIMENTAL', 'label': 'levofloxacin for non-diabetic patients', 'description': '50 non-diabetic patients received intravenous levofloxacin 750mg/24 hours.', 'interventionNames': ['Drug: Levofloxacin 750 MG']}], 'interventions': [{'name': 'Ciprofloxacin 400 MG/200 ML Intravenous Solution', 'type': 'DRUG', 'description': 'antibiotic', 'armGroupLabels': ['ciprofloxacin for diabetic patients', 'ciprofloxacin for non-diabetic patients']}, {'name': 'Levofloxacin 750 MG', 'type': 'DRUG', 'description': 'antibiotic', 'armGroupLabels': ['levofloxacin for diabetic patients', 'levofloxacin for non-diabetic patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Beni-Suef university hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed A Elberry, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of medicine, Beni-Suef university, Beni-Suef, Egypt'}, {'name': 'Hazem S Hussein, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of medicine, Beni-Suef university, Beni-Suef, Egypt'}, {'name': 'Raghda R Sayed, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of pharmacy, Beni-Suef university, Beni-Suef, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical pharmacist', 'investigatorFullName': 'Nada Abd El-Hamed Saad Rezk', 'investigatorAffiliation': 'Beni-Suef University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-07-06', 'type': 'RELEASE'}, {'date': '2020-07-20', 'type': 'RESET'}, {'date': '2020-07-20', 'type': 'RELEASE'}, {'date': '2020-08-04', 'type': 'RESET'}, {'date': '2020-08-22', 'type': 'RELEASE'}, {'date': '2020-09-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nada Abd El-Hamed Saad Rezk, Principle investigator, Beni-Suef University'}}}}