Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT04531332
Status:
UNKNOWN
Last Update Posted:
2021-09-16
First Post:
2020-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Infusion of Linezolid Versus Intermittent Dosing in the Treatment of Nosocomial Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 169}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of cured patients in the linezolid continuous infusion group versus the proportion of cured patients in the intermittent group', 'timeFrame': 'through study completion, over one year', 'description': 'The primary efficacy endpoint will be evaluated as clinical cure on day 7 of Linezolid initiation.\n\nClinical cure defined by normalized body temperature, TLC less than 10,000/mL, absence of purulent secretions, and improvement of radiological findings (x-ray), in addition to Pao2/Fio2 greater than 250 in patients.'}, {'measure': 'Percentage of occurrence of anemia and thrombocytopenia', 'timeFrame': 'through study completion, over one year', 'description': "The patients' hematological parameters (hemoglobin (Hb), hematocrit (Hct), and platelets (PLTs) counts) will be compared every 2 days during linezolid treatment between two groups.\n\nAnemia is defined as decrease in hemoglobin level \\<10 g/dl and Thrombocytopenia is defined as decrese in platelets count \\<100 × 103/mm3"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['linezolid continuous infusion', 'pneumonia', 'critically ill patients'], 'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': "The investigator's goal in this study is to determine the clinical efficacy and safety of continuous infusion in comparison with standard intermittent infusion.", 'detailedDescription': 'Prospective randomized controlled clinical trial on critically ill Pneumonic patients, included two groups, over one year period. The first group will be administered intravenous (IV) linezolid 600mg twice daily. The second group will be prescribed linezolid (IV) 600 mg loading dose followed by 1200 mg by continuous infusion. Both groups will be co-administered intravenous (IV) Meropenem 1g every 8 hours empirically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Adult, Older Adult', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to ICUs diagnosed as HAP or VAP\n* Chest X-ray/ computed tomography showing new or progressive infiltrate.\n* New onset of purulent sputum or change in sputum character.\n* Body temperature greater than 38 ℃ or less than 35.5℃.\n* White blood cell counts greater than 10000 /mm3 or less than 4000 /mm3.\n* Significant quantitative pathogen cultures from respiratory secretions.\n\nExclusion Criteria:\n\n* Age \\<18 years, Pregnancy, Lactation\n* Previous known allergic reaction to linezolid\n* Creatinine Clearance (CrCl) \\<10 mL/min, calculated according to the Cockcroft-Gault formula\n* Thrombocytopenia (platelet count less than 80,000/mm3)\n* Severe hepatic failure (Child-Pugh C)\n* Concomitant treatment with other drugs that can potentially interfere with Linezolid (i.e., macrolides, serotonin modulators, omeprazole)\n* Acute DIC score \\> 4 points or hematological disorder\n* Concurrent drug-associated Thrombocytopenia'}, 'identificationModule': {'nctId': 'NCT04531332', 'briefTitle': 'Continuous Infusion of Linezolid Versus Intermittent Dosing in the Treatment of Nosocomial Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Efficacy and Safety of Continuous Infusion of Linezolid Compared With Intermittent Dosing in Critically Ill Pneumonic Patients', 'orgStudyIdInfo': {'id': 'REC-H-PhBSU-20004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous infusion', 'description': 'Patients will be received linezolid 600 mg intravenous Loading dose over 30 to 60 minutes followed by 1200 mg/ day by Continuous infusion (50 mg /hr)', 'interventionNames': ['Drug: Continuous infusion Linezolid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intermittent dosing', 'description': 'Patients will be received Linezolid 600 mg intravenous twice daily over 30 to 60 minutes', 'interventionNames': ['Drug: intermittent dosing linezolid']}], 'interventions': [{'name': 'Continuous infusion Linezolid', 'type': 'DRUG', 'otherNames': ['intervention'], 'description': 'Linezolid 600 mg intravenous Loading dose followed by 1200 mg/ day by Continuous infusion ( 50 mg /hr )', 'armGroupLabels': ['Continuous infusion']}, {'name': 'intermittent dosing linezolid', 'type': 'DRUG', 'otherNames': ['control'], 'description': 'Linezolid 600 mg intravenous twice daily', 'armGroupLabels': ['Intermittent dosing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banī Suwayf', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed E Abou Warda, BSc', 'role': 'CONTACT', 'email': 'ahmed.essam@o6u.edu.eg', 'phone': '00201007647696'}, {'name': 'Rania M Soliman, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ayman N Moharram, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Heba Farouk, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beni-suef University', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'centralContacts': [{'name': 'Ahmed E Abou warda, BSc', 'role': 'CONTACT', 'email': 'ahmed.essam@o6u.edu.eg', 'phone': '00201007647696'}, {'name': 'Rania M Sarhan, PhD', 'role': 'CONTACT', 'phone': '0021008789509'}], 'overallOfficials': [{'name': 'Ahmed Essam, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'October 6 University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beni-Suef University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Ahmed Essam', 'investigatorAffiliation': 'October 6 University'}}}}