Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-03 @ 9:01 PM
Study NCT ID:
NCT03645668
Status:
COMPLETED
Last Update Posted:
2020-03-13
First Post:
2018-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077731', 'term': 'Meropenem'}], 'ancestors': [{'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-11', 'studyFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T>MIC', 'timeFrame': 'Day 1', 'description': 'Time above MIC% per administration interval'}], 'secondaryOutcomes': [{'measure': 'APACHE II score', 'timeFrame': 'Day 0,Day 4,Day 8', 'description': 'Change of Acute physiology and chronic health evaluation score (APACHE II score) during period of treatment'}, {'measure': 'SOFA', 'timeFrame': 'Day 0,Day 4,Day 8', 'description': 'Change of Sepsis-related Organ Failure Assessment score (sofa) during period of treatment'}, {'measure': 'Mortality', 'timeFrame': 'Day 28', 'description': 'Mortality within 28 days'}, {'measure': 'highest temperature', 'timeFrame': 'Day 0,Day 4,Day 8', 'description': 'Variation of the highest temperature'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis，meropenem，2 steps administration'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data', 'detailedDescription': 'This study is a prospective, randomized controlled trial, which the subjects were severe sepstic patients for selecting Meropenem as antimicrobial drugs. The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data, eventually demonstrate the effecacy and safety of Meropenem in patients with severe infection and optimize the best clinical practice for antimicrobial agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Inpatients, whose informed consent has been obtained;\n2. Clinical diagnosis of Sepsis\n\nExclusion Criteria:\n\n1. Pregnancy or lactation;\n2. Treated with other carbapenems;\n3. Cannot be evaluated for efficacy and safety result from lack of clinical and laboratory parameter for Infection assessment;\n4. Allergy to meropenem or other β-lactams, or the history of allergy;\n5. Resistant to meropenem according to the antimicrobial susceptibility test;\n6. Epilepsy or history of epilepsy;\n7. History of seizures;\n8. Combined medicine with sodium valproate;\n9. Combined medicine with anti-MRSA, anti-fungal drugs;\n10. with severe liver or renal dysfunction;\n11. Terminal cancer;\n12. Septic shock;\n13. APACH II ≥20;\n14. Inappropriate to participate in the trial evaluated by investigator.'}, 'identificationModule': {'nctId': 'NCT03645668', 'briefTitle': 'Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Efficacy and Pharmacokinetics of Meropenem in Different Administration for Patients With Severe Sepsis', 'orgStudyIdInfo': {'id': 'XH-18-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'meropenem injection, 1.0g, q8h,intravenous infusion ,0.5g/0.5h+0.5g/4h', 'interventionNames': ['Drug: Meropenem Injection']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'meropenem injection, 1.0g, q8h,continuous intravenous infusion duration ,1h', 'interventionNames': ['Drug: Meropenem Injection']}], 'interventions': [{'name': 'Meropenem Injection', 'type': 'DRUG', 'otherNames': ['meropenem,MEPEM'], 'description': 'Different administration types between two groups', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Xinhua Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Aihua FEI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}