Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT01964495
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2013-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 468}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2013-09-30', 'studyFirstSubmitQcDate': '2013-10-14', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of antibiotic treatment', 'timeFrame': 'End of the study'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'End of the study'}, {'measure': 'Clinical response', 'timeFrame': 'End of the study', 'description': 'Cure - resolution or improvement of symptoms and clinical signs related to pneumonia without the need for additional or alternative antibiotic therapy\n\nFailure - persistence or progression of all signs and symptoms of the acute process after randomisation or the development of a new pulmonary or extrapulmonary respiratory tract infection, or the progression of abnormalities on chest radiograph after randomisation, or death due to pneumonia, or the inability to complete the study owing to adverse events\n\nIndeterminate - patient receives less than 80% of the study drug for reasons other than clinical failure, a concomitant infection outside the respiratory tract requiring antibiotic treatment, lost to follow-up, or death unrelated to the primary diagnosis.'}, {'measure': '30-day mortality', 'timeFrame': 'End of the study, periodically by the DSMB', 'description': 'All cause'}, {'measure': 'Time to clinical stability', 'timeFrame': 'End of the study', 'description': 'Patients are considered clinically stable if they fulfill all of these criteria: Temperature equal to or below 37.8 degrees celsius, heart rate equal to or below 100 beats per minute, respiratory rate equal to or below 24 breaths per minute, systolic blood pressure equal to or above 90 mmHg, arterial oxygen saturation equal to or above 90 percent or pO2 equal to or above 60 mmHg on room air, ability to maintain oral intake, normal mental status.'}, {'measure': 'Relapse rate', 'timeFrame': 'End of the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Community Acquired Pneumonia']}, 'referencesModule': {'references': [{'pmid': '40523722', 'type': 'DERIVED', 'citation': 'Hessels L, Duijkers R, Schoorl M, Terpstra L, Thijs W, Boersma W. The Value of Soluble Urokinase Plasminogen Activator Receptor (suPAR) as Predictive Tool in Hospitalised Patients With Community-Acquired Pneumonia (CAP). Clin Respir J. 2025 Jun;19(6):e70089. doi: 10.1111/crj.70089.'}, {'pmid': '39163362', 'type': 'DERIVED', 'citation': 'Duijkers R, Prins HJ, Kross M, Snijders D, van den Berg JWK, Werkman GM, van der Veen N, Schoorl M, Bonten MJM, van Werkhoven CH, Boersma WG. Biomarker guided antibiotic stewardship in community acquired pneumonia: A randomized controlled trial. PLoS One. 2024 Aug 20;19(8):e0307193. doi: 10.1371/journal.pone.0307193. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate two different treatment strategies in patients admitted to hospital with Community Acquired Pneumonia. The investigators hypothesize treatment according to both procalcitonin (PCT) and C-reactive protein (CRP) will be effective in reducing the length of antibiotic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale and female patients with a diagnosis of CAP and all criteria listed below:\n\n1. Age 18 or above, no upper age limit will be employed.\n2. Patients must require hospitalisation.\n3. Clinical presentation of an acute illness with one or more of the following symptoms:\n\n 1. Temperature ≥ 38.0 ⁰C (100.4°F)\n 2. Dyspnoea\n 3. Cough (with or without expectoration of sputum)\n 4. Chest pain\n 5. Malaise or fatigue\n 6. Myalgia\n 7. Gastro-intestinal symptoms\n 8. Rales, rhonchi or wheezing\n 9. Egophony or bronchial breath sounds\n4. New consolidation(s) on the chest radiograph.\n5. Written informed consent obtained.\n6. (Pre-event) Life expectancy \\> 30 days\n\nExclusion Criteria:\n\nSubjects presenting with any of the following will not be included in the study:\n\n1. (Severe) immunosuppression (e.g. HIV infection, chemotherapy, use of immunosuppressants).\n2. Active neoplastic disease.\n3. Obstruction pneumonia (e.g. from lung cancer).\n4. Aspiration pneumonia.\n5. Pneumonia that developed within 8 days after hospital discharge.\n6. Unable and/or unlikely to comprehend and/or follow the protocol.\n7. Pregnant and/or lactating women.\n8. Other infection that requires treatment with antibiotics'}, 'identificationModule': {'nctId': 'NCT01964495', 'acronym': 'REDUCE', 'briefTitle': 'Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)', 'organization': {'class': 'OTHER', 'fullName': 'Medical Center Alkmaar'}, 'officialTitle': 'Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)', 'orgStudyIdInfo': {'id': '1-Duijkers'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Common clinical practice', 'description': 'Treatment according to current guidelines. Often a 7 day course of antibiotics. Initial treatment should be broad spectrum antibiotics and can be narrowed down if a specific pathogen is identified.', 'interventionNames': ['Drug: Treatment according to current guidelines']}, {'type': 'EXPERIMENTAL', 'label': 'CRP-guided treatment', 'description': 'Treatment according to CRP levels. Patients will be started on broad spectrum antibiotics for at least 3 days, treatment can be switched to small-spectrum antibiotics if a specific pathogen is identified. From day 4 to 7 daily blood tests will be performed in order to evaluate whether or not treatment can be discontinued. If treatment is discontinued, no more blood tests will be performed.', 'interventionNames': ['Drug: Discontinuation of treatment according to CRP levels']}, {'type': 'EXPERIMENTAL', 'label': 'PCT guided treatment', 'description': 'Treatment according to PCT levels. Patients will be started on broad spectrum antibiotics for at least 3 days, treatment can be switched to small-spectrum antibiotics if a specific pathogen is identified. From day 4 to 7 daily blood tests will be performed in order to evaluate whether or not treatment can be discontinued. If treatment is discontinued, no more blood tests will be performed.', 'interventionNames': ['Drug: Discontinuation of treatment according to PCT levels']}], 'interventions': [{'name': 'Discontinuation of treatment according to CRP levels', 'type': 'DRUG', 'otherNames': ['Broad spectrum antibiotics', 'Small spectrum antibiotics'], 'description': 'The cutoff point is a CRP below 100 mg/L and a reduction to 50% of the initial value.', 'armGroupLabels': ['CRP-guided treatment']}, {'name': 'Discontinuation of treatment according to PCT levels', 'type': 'DRUG', 'otherNames': ['Broad spectrum antibiotics', 'Small spectrum antibiotics'], 'description': 'The cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value.', 'armGroupLabels': ['PCT guided treatment']}, {'name': 'Treatment according to current guidelines', 'type': 'DRUG', 'otherNames': ['Broad spectrum antibiotics', 'Small spectrum antibiotics'], 'description': 'Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary.', 'armGroupLabels': ['Common clinical practice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1815JD', 'city': 'Alkmaar', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Medical Centre Alkmaar', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'zip': '1006BK', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Slotervaart Hospital', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '8025 AB', 'city': 'Zwolle', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'ISALA clinics', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Ruud Duijkers, MSc, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medisch Centrum Alkmaar'}, {'name': 'Wim G Boersma, MD, PhD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medisch Centrum Alkmaar'}, {'name': 'Dominic Snijders, MSc, PhD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Slotervaart ziekenhuis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Center Alkmaar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foreest Medical School', 'class': 'UNKNOWN'}, {'name': 'Pulmoscience', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc, MD, PhD', 'investigatorFullName': 'W.G.Boersma', 'investigatorAffiliation': 'Medical Center Alkmaar'}}}}