Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-31 @ 1:29 PM
Study NCT ID:
NCT01660204
Status:
COMPLETED
Last Update Posted:
2014-04-23
First Post:
2012-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-Acquired Pneumonia - Study on the Initial Treatment With Antibiotics of Lower Respiratory Tract Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2283}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-22', 'studyFirstSubmitDate': '2012-05-02', 'studyFirstSubmitQcDate': '2012-08-03', 'lastUpdatePostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Day 90 Mortality', 'timeFrame': '90 days from admission', 'description': 'We will assess all-cause mortality on day 90 from admission from the municipal personal records database'}], 'secondaryOutcomes': [{'measure': 'Length of intravenous antibiotic treatment', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 1 week'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 1 week'}, {'measure': 'Tolerability', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 1 week', 'description': 'Side-effects and complications from antibiotic therapy are registered from clinical record'}, {'measure': 'Complications', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 1 week', 'description': 'Complications of pneumonia during admission are registered from clinical record.'}, {'measure': 'Health care costs and non-health care costs', 'timeFrame': '28 days from admission', 'description': 'Health care costs and non-health care costs are assessed using a short questionnaire 28 days from admission'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pneumonia, anti-bacterial agents, (cost)efficacy'], 'conditions': ['Community-acquired Pneumonia']}, 'referencesModule': {'references': [{'pmid': '30612559', 'type': 'DERIVED', 'citation': 'Postma DF, Spitoni C, van Werkhoven CH, van Elden LJR, Oosterheert JJ, Bonten MJM. Cardiac events after macrolides or fluoroquinolones in patients hospitalized for community-acquired pneumonia: post-hoc analysis of a cluster-randomized trial. BMC Infect Dis. 2019 Jan 7;19(1):17. doi: 10.1186/s12879-018-3630-7.'}, {'pmid': '28068956', 'type': 'DERIVED', 'citation': 'van Werkhoven CH, Postma DF, Mangen MJ, Oosterheert JJ, Bonten MJ; CAP-START study group. Cost-effectiveness of antibiotic treatment strategies for community-acquired pneumonia: results from a cluster randomized cross-over trial. BMC Infect Dis. 2017 Jan 10;17(1):52. doi: 10.1186/s12879-016-2179-6.'}, {'pmid': '25830421', 'type': 'DERIVED', 'citation': 'Postma DF, van Werkhoven CH, van Elden LJ, Thijsen SF, Hoepelman AI, Kluytmans JA, Boersma WG, Compaijen CJ, van der Wall E, Prins JM, Oosterheert JJ, Bonten MJ; CAP-START Study Group. Antibiotic treatment strategies for community-acquired pneumonia in adults. N Engl J Med. 2015 Apr 2;372(14):1312-23. doi: 10.1056/NEJMoa1406330.'}, {'pmid': '24846935', 'type': 'DERIVED', 'citation': 'van Werkhoven CH, Postma DF, Oosterheert JJ, Bonten MJ. Antibiotic treatment of moderate-severe community-acquired pneumonia: design and rationale of a multicentre cluster-randomised cross-over trial. Neth J Med. 2014 Apr;72(3):170-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the cost(effectiveness) of three existing antibiotic strategies for patients with community-acquired pneumonia admitted to the hospital, but not the ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted to one of the participating hospitals needing treatment for CAP, not being admitted to the ICU are eligible for study inclusion.\n* Admission is defined as hospital stay for more than 24 hours.\n\nExclusion Criteria:\n\n* Patients who are readmitted with CAP within 2 weeks after a previous episode are not eligible.\n* Patients with cystic fibrosis are not eligible.'}, 'identificationModule': {'nctId': 'NCT01660204', 'acronym': 'CAP-START', 'briefTitle': 'Community-Acquired Pneumonia - Study on the Initial Treatment With Antibiotics of Lower Respiratory Tract Infections', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Antibiotic Treatment of Community-acquired Pneumonia: a Prospective Comparison of Dutch Guideline Advices.', 'orgStudyIdInfo': {'id': '10-148'}, 'secondaryIdInfos': [{'id': '80-82310-97-12044', 'type': 'OTHER_GRANT', 'domain': 'ZonMw'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Betalactam monotherapy', 'description': 'Preferred empirical treatment for patients in this arm is Beta-lactam monotherapy e.g. co-amoxiclav or ceftriaxone', 'interventionNames': ['Other: Preferred empirical treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Betalactam combination with macrolide', 'description': 'Preferred empirical treatment for patients in this arm is beta-lactam combination therapy with a macrolide e.g. ceftriaxone and erythromycin', 'interventionNames': ['Other: Preferred empirical treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Quinolone monotherapy', 'description': 'Preferred empirical treatment for patients in this arm is quinolone monotherapy e.g. moxifloxacin or levofloxacin', 'interventionNames': ['Other: Preferred empirical treatment']}], 'interventions': [{'name': 'Preferred empirical treatment', 'type': 'OTHER', 'description': 'The investigators are using a cluster-randomized cross-over design for preferred empirical treatment. One of the 3 treatment arms is used as preferred empirical therapy during a period of 4 consecutive months, after which preferred treatment will rotate to 1 of the other 2 regimens. The order of change is randomised per hospital, thereby controlling for inter-hospital variables and minimizing seasonal influences.', 'armGroupLabels': ['Betalactam combination with macrolide', 'Betalactam monotherapy', 'Quinolone monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Medical Center Alkmaar', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'AMC Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Hospital Breda', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Haarlem', 'country': 'Netherlands', 'facility': 'Kennemer Gasthuis', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'city': 'Hoofddorp', 'country': 'Netherlands', 'facility': 'Spaarne Hospital', 'geoPoint': {'lat': 52.3025, 'lon': 4.68889}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Diakonessenhuis Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Marc J. Bonten, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'MJM Bonten', 'investigatorAffiliation': 'UMC Utrecht'}}}}