Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-04 @ 3:27 AM
Study NCT ID:
NCT03229135
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2017-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-21', 'studyFirstSubmitDate': '2017-07-19', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum teicoplanin trough concentrations', 'timeFrame': '0.5 hour before teicoplanin administration on the fourth day', 'description': 'Teicoplanin trough samples were taken immediately 30 minutes before teicoplanin administration on the fourth day. Blood samples for 2-3 mL were collected in blood-collection tubes without any additives and centrifuged at 3500 rpm for 10min. Serum teicoplanin trough concentrations (Cmin) were determined by a high-performance liquid chromatography method as previously described. The detections were completed in Translational Medicine Center of Zhengzhou Central Hospital affiliated to Zhengzhou University.'}], 'secondaryOutcomes': [{'measure': 'White blood cell count (WBC)', 'timeFrame': '2 years', 'description': 'It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.'}, {'measure': 'C-reaction protein (CRP)', 'timeFrame': '2 years', 'description': 'It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.'}, {'measure': 'Asparttate aminotransferase (AST)', 'timeFrame': '2 years', 'description': 'It is an indicator of liver function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.'}, {'measure': 'Alanine aminotransferase (ALT)', 'timeFrame': '2 years', 'description': 'It is an indicator of liver function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.'}, {'measure': 'Serum creatinine (Scr)', 'timeFrame': '2 years', 'description': 'It is an indicator of renal function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.'}, {'measure': 'CLcr', 'timeFrame': '2 years', 'description': 'It is an indicator of renal function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pneumonia Gram-Positive Bacterial']}, 'descriptionModule': {'briefSummary': 'This was a retrospective study that all teicoplanin-treated adult patients with Gram-positive infections admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from February 2015 to August 2016.', 'detailedDescription': '1. Patients and protocol This was a retrospective study that all teicoplanin-treated adult patients with Gram-positive infections admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from February 2015 to August 2016. Patients were included who met the following criteria: (1) age≥18 years, (2) duration of teicoplanin therapy≥5 days, (3) written informed consent was obtained from each patients. Patients were excluded who fulfilled any of the following criteria: (1) Patients who were allergy to teicoplanin, (2) pregnant women, (3) patients with hematopoietic function, (4) patients unable to evaluate efficacy and safety. This study was approved by the research ethics committee of the Zhengzhou Central Hospital affiliated to Zhengzhou University.\n2. Treatment regimen and groups According to CLcr and teicoplanin loading dose regimen, all patients were divided into four groups. Group A (CLcr≥60mL/min) : Teicoplanin was intravenously administered 3 times for moderate infections (skin, soft tissue and respiratory infections) or 6 times for severe infections(endocarditis caused by MRSA or severe pneumonia) at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d. Group B (40 mL/min≤CLcr\\<60mL/min) : Teicoplanin was intravenously administered 3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d. Group C (CLcr\\<40mL/min) : Teicoplanin was intravenously administered 2 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d. Group D (standard regimen) : Teicoplanin was intravenously administered 1-3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d. The maintenance dosing was adjusted by Cmin and CLcr in all groups. The target Cmin was set to 15\\~30 mg/L. If Cmin\\<15 mg/L or \\>30 mg/L, the maintenance dosage was increased or decreased appropriately up to target Cmin range. CLcr values for male and female were calculated based on the following equations, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The clinical data of 113 patients who were suffered with severe Gram-positive infection and treated with teicoplanin from February 2015 to August 2016 were retrospectively analyzed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age≥18 years\n* duration of teicoplanin therapy≥5 days\n* written informed consent was obtained from each patients\n\nExclusion Criteria:\n\n* Patients who were allergy to teicoplanin\n* pregnant women\n* patients with hematopoietic function\n* patients unable to evaluate efficacy and safety'}, 'identificationModule': {'nctId': 'NCT03229135', 'briefTitle': 'Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections', 'organization': {'class': 'OTHER', 'fullName': "People's Hospital of Zhengzhou University"}, 'officialTitle': 'A Retrospective Study of Relationships Between Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections Treated With Teicoplanin', 'orgStudyIdInfo': {'id': 'LZhou'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Group A (CLcr≥60mL/min) : Teicoplanin was intravenously administered 3 times for moderate infections (skin, soft tissue and respiratory infections) or 6 times for severe infections(endocarditis caused by MRSA or severe pneumonia) at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d.', 'interventionNames': ['Device: other antibacterial agents，breathing machine']}, {'label': 'Group B', 'description': 'Group B (40 mL/min≤CLcr\\<60mL/min) : Teicoplanin was intravenously administered 3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d.', 'interventionNames': ['Device: other antibacterial agents，breathing machine']}, {'label': 'Group C', 'description': 'Group C (CLcr\\<40mL/min) : Teicoplanin was intravenously administered 2 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d.', 'interventionNames': ['Device: other antibacterial agents，breathing machine']}, {'label': 'Group D', 'description': 'Group D (standard regimen) : Teicoplanin was intravenously administered 1-3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d.', 'interventionNames': ['Device: other antibacterial agents，breathing machine']}], 'interventions': [{'name': 'other antibacterial agents，breathing machine', 'type': 'DEVICE', 'description': 'If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents. Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "People's Hospital of Zhengzhou University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'LIjuan Zhou', 'investigatorAffiliation': "People's Hospital of Zhengzhou University"}}}}