Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-28 @ 3:13 AM
Study NCT ID:
NCT02400268
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2014-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Treatment Duration (7 vs 14 Days) Comparison in Blood Stream Infection Causes by Enterobacteriaceae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D000084063', 'term': 'Reinfection'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2014-08-05', 'studyFirstSubmitQcDate': '2015-03-23', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days of antimicrobial treatment', 'timeFrame': '28 days', 'description': 'To prove that 7-days course of antibiotic therapy is more efficient than 14-days course when treating Enterobacteriaceae bacteremia, in terms of number of days at the end of follow up.'}], 'secondaryOutcomes': [{'measure': 'Adverse reactions related to antimicrobial treatment', 'timeFrame': '28 days', 'description': 'To prove that 7-days course of antibiotic therapy is as safe as a 14-days course in terms of : Rate of adverse effects including: adverse reactions to drugs, superinfections by resistant bacteria or diarrhea by Clostridium difficile, mortality, relapse of the infection'}, {'measure': 'Cure of bacteremia', 'timeFrame': '28 days', 'description': 'Clinical and microbiological cure'}, {'measure': 'Procalcitonin levels', 'timeFrame': '7-days and 14-days', 'description': 'To analyze the utility of procalcitonin as a biomarker to decide the end of the antimicrobial treatment of Enterobacteriaceae bacteremia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Enterobacteriaceae', 'Bloodstream', 'Bacteremia', 'Recurrence', 'Reinfection'], 'conditions': ['Enterobacteriaceae Infections', 'Bloodstream Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.reipi.org/', 'label': 'This organization is formed by 16 Spanish leading research groups in the field, is public funded by Spanish Carlos III Institute and co-financed by European Development Regional Fund (ERDF)'}]}, 'descriptionModule': {'briefSummary': 'The antimicrobial crisis is a real problem. Infections produced by multiresistant bacteria are becoming more and more frequent, and available antimicrobial agents are usually scarce. Reducing the duration of antimicrobial treatments is one of the most efficient measures to control the antibiotic pressure and to optimise the use of these agents.\n\nBloodstream infections produced by Enterobacteria (EB) are very frequent, but the optimal duration of antibiotics to treat them is unknown, as long as no clinical trials have been specifically developed to answer this question.\n\nBasing on expert opinions, the Infectious Diseases Society pf America (IDSA) recommends the bacteremia by EB secondary to vascular catheter infections to be treated for 7 to 14 days. This represents a variability of up to 100%. No recommendations have been published regarding the duration of treatment of bacteremia from other sources.\n\nThe objective of this project is to prove that the 7-day course of treatment for EB bacteremia is more efficient and equally safe than the 14-day scheme.', 'detailedDescription': 'To achieve theses objectives, we propose this randomized, multicentric clinical trial with a superiority design on the duration of antimicrobial treatment for EB bacteremia in adult patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adults patients (equal or over 18 years old)\n* Primary or secondary bloodstream infection produced by enterobacteriaceae\n* Source of bacteremia properly controlled or expect to be properly controlled in the next 24 hours (i.e. bacteremia produced by infected vascular catheter, abscess, obstruction of the biliary or urinary tract).\n* Patients able to understand the objectives of the clinical trial and informed consent signed.\n\nExclusion Criteria:\n\n* Pregnancy\n* Post-chemotherapy neutropenia expected to persist more than 7 days.\n* Source of bacteremia uncontrolled at inclusion period or in the following 24 hours. The source will be considered as uncontrolled if the bacteremia is secondary to a suppurative infection potentially removable, if no action has been taken to eradicate it, including: bacteremia by vascular not removed catheter, cholangitis secondary to not derived obstruction of the biliary tract, deep abscess not drained, pyohydronephrosis without derivation of the urinary tract.\n* Bacteremia secondary to infective endocarditis, bone and joint infections, or neurosurgical infections, which may require prolonged antimicrobial therapy\n* Bacteremia due to enterobacteriaceae resistant to carbapenemics.\n* Polymicrobial bacteremia including microorganisms different to enterobacteriaceae.\n* Patients with no expectations of survival in the next 48 hours of inclusion.'}, 'identificationModule': {'nctId': 'NCT02400268', 'acronym': 'SHORTEN', 'briefTitle': 'Antibiotic Treatment Duration (7 vs 14 Days) Comparison in Blood Stream Infection Causes by Enterobacteriaceae', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla'}, 'officialTitle': 'Phase 4, Randomized, Controlled Multicentric, Open-label Clinical Trial to Prove That the 7 Day Course of Treatment for Enterobacteriaceae Bacteremia is More Efficient and Equally Safe Than 14 Day Scheme', 'orgStudyIdInfo': {'id': 'SHORTEN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '7 days course of antibiotic treatment', 'description': 'Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines.', 'interventionNames': ['Other: 7 days course of antibiotic treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': '14 days course of antibiotic treatment', 'description': 'Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines.', 'interventionNames': ['Other: 14 days course of antibiotic treatment']}], 'interventions': [{'name': '7 days course of antibiotic treatment', 'type': 'OTHER', 'otherNames': ['Antibiotics with approved indication'], 'description': 'Standard antibiotic treatment approved for enterobacteraciae infections', 'armGroupLabels': ['7 days course of antibiotic treatment']}, {'name': '14 days course of antibiotic treatment', 'type': 'OTHER', 'otherNames': ['Antibiotics with approved indication'], 'description': 'Standard antibiotic treatment approved for enterobacteraciae infections', 'armGroupLabels': ['14 days course of antibiotic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14004', 'city': 'Córdoba', 'state': 'Córdoba', 'country': 'Spain', 'facility': 'University Hospital Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Universitary Hospital Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '41007', 'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'University Hospital Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41013', 'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Jose Molina Gil-Bermejo, MD. PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospitales Universitarios Virgen del Rocío'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anonimized data for primary and secondary variables is planned to be shared with all the participants within 6 months of data completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}