Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT00445094
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2007-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015378', 'term': 'Imipenem'}, {'id': 'D015377', 'term': 'Cilastatin'}, {'id': 'D000081206', 'term': 'Duration of Therapy'}], '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'}, {'id': 'D003521', 'term': 'Cyclopropanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-15', 'studyFirstSubmitDate': '2007-03-06', 'studyFirstSubmitQcDate': '2007-03-06', 'lastUpdatePostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A 30-day-survival rate in the intensive care unit evaluated by Acute Physiology and Chronic Health (APACH II) Disease Classification System II score'}]}, 'conditionsModule': {'conditions': ['Infection', 'Pneumonia']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'type': 'CSR Synopsis'}], 'seeAlsoLinks': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'label': 'Click here to access a synopsis of the study results.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is a comparison between MK0787B and standard therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Greater than 18 years of age\n* Patient is diagnosed with nosocomial pneumonia\n\nExclusion Criteria:\n\n* Immunological deficient patients\n* Pregnant women and nursing mothers\n* A fungus is identified before the study enrollment\n* Received vancomycin or imipenem for more than 5 days before icu admission'}, 'identificationModule': {'nctId': 'NCT00445094', 'briefTitle': 'A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit', 'orgStudyIdInfo': {'id': '0787B-092'}, 'secondaryIdInfos': [{'id': '2007_004'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days', 'type': 'DRUG'}, {'name': 'Comparator: amikacin / Duration of Treatment: 3 Days', 'type': 'DRUG'}, {'name': 'Comparator: tazocin / Duration of Treatment: 3 Days', 'type': 'DRUG'}, {'name': 'Comparator: vancomycin / Duration of Treatment: 3 Days', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}