Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT06295120
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2024-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment failure at day 30', 'timeFrame': 'From randomisation to day 30', 'description': 'Treatment failure is defined as any hospitalisation OR change in the antibiotic strategy (i.e., prolongation of the duration, change in antibiotic type, new antibiotic prescription) due to symptoms of acute respiratory tract infection - between randomisation and day 30.'}], 'secondaryOutcomes': [{'measure': 'Clinical recovery at day 8', 'timeFrame': 'From randomisation to day 8', 'description': 'Clinical recovery is defined as: The participant scores below a pre-defined cut-off point for being recovered at the Acute Respiratory Tract Infection Questionnaire OR reports feeling recovered by themselves AND the participant is no longer treated with any antibiotics.'}, {'measure': 'The Acute Respiratory Tract Infection Questionnaire (ARTIQ) score', 'timeFrame': 'At randomisation day and day 8', 'description': 'The Acute Respiratory Tract Infection Questionnaire is a validated, self-administered, multidimensional, sum-scaling symptom score monitoring the severity and functional impact of acute respiratory tract infections in general practice. The questionnaire consists of five single items and 37 items covering five independent dimensions: upper respiratory tract symptoms, lower respiratory tract symptoms, physiological, sleep, and medicine. The participants will be asked to evaluate each item, over the past 24 hours by using a three-point scale: "No (0 point)", "Yes - some (1 point)" or "Yes - a lot (2 points)". Ten items are dichotomized: "Yes (1 point) or "No (0 point)"). The total ARTIQ score is calculated as the sum of each dimension and single items (minimum 0 - maximum 74).'}, {'measure': 'Prolonged antibiotic treatment', 'timeFrame': 'From randomisation to day 30', 'description': 'Proportion of participants in need of prolonged antibiotic treatment.'}, {'measure': 'Change in type of antibiotic', 'timeFrame': 'From randomisation to day 30', 'description': 'Proportion of participants who had prescribed another type of antibiotic treatment'}, {'measure': 'Relapse of acute Lower Respiratory Tract Infection (LRTI)', 'timeFrame': 'From randomisation to day 30', 'description': 'Proportion of participants with relapse of acute LRTI'}, {'measure': 'Reconsultation', 'timeFrame': 'From randomisation to day 30', 'description': 'Number of reconsultations at general practice or out-off-hour services'}, {'measure': 'New prescriptions within 30 days', 'timeFrame': 'From randomisation to day 30', 'description': 'Proportion of participants with new prescriptions of symptomatic treatment (e.g. prednisolone, bronchodilator etc) within 30 days'}, {'measure': 'Hospitalisation', 'timeFrame': 'From randomisation to day 30', 'description': 'Proportion of participants hospitalised within 30 days'}, {'measure': 'Mortality', 'timeFrame': 'From randomisation to day 30', 'description': 'All-cause mortality at day 30'}, {'measure': 'Adverse events', 'timeFrame': 'From randomisation to day 30', 'description': 'Proportion of participants experiencing adverse or serious adverse events'}, {'measure': 'Treatment adherence', 'timeFrame': 'From randomisation to day 8', 'description': 'Initiation, implementation and discontinuation of the allocated treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Community-acquired pneumonia', 'Treatment duration', 'Phenoxymethylpenicillin', 'General Practice'], 'conditions': ['Community-acquired Pneumonia']}, 'referencesModule': {'references': [{'pmid': '39334468', 'type': 'DERIVED', 'citation': 'Johansen E, Nielsen H, Gillespie D, Aabenhus R, Hansen MP. The optimal antibiotic treatment duration for community-acquired pneumonia in adults diagnosed in general practice in Denmark (CAP-D): an open-label, pragmatic, randomised controlled trial. Trials. 2024 Sep 27;25(1):627. doi: 10.1186/s13063-024-08477-z.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-acquired pneumonia diagnosed in general practice.\n\nEligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.\n\nConsenting patients who meet all the eligibility criteria will be randomised (1:1:1:1:1) to either three, four, five, six or seven days of treatment with phenoxymethylpenicillin 1.2 MIE four times daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnoea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.\n\nExclusion Criteria:\n\n1. Need for immediate hospitalisation at the time of diagnosis.\n2. Known allergy to beta-lactam antibiotics.\n3. Any coinfection necessitating antibiotic treatment.\n4. Use of systemic antibiotics or antivirals within the last month.\n5. Pre-existing lung disease (e.g., chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer).\n6. Known immunosuppression (i.e., long term treatment with corticosteroid, chemotherapy, or immune disorder).\n7. Pregnant or lactating.\n8. Patients not capable of consenting and/or patients deemed non-suitable for participation by the healthcare professional.'}, 'identificationModule': {'nctId': 'NCT06295120', 'acronym': 'CAP-D', 'briefTitle': 'The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)', 'organization': {'class': 'OTHER', 'fullName': 'Research Unit for General Practice in Aalborg'}, 'officialTitle': 'The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark: an Open-Label, Pragmatic, Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '362-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3 days', 'description': '3 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.', 'interventionNames': ['Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily']}, {'type': 'EXPERIMENTAL', 'label': '4 days', 'description': '4 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.', 'interventionNames': ['Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily']}, {'type': 'EXPERIMENTAL', 'label': '5 days', 'description': '5 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.', 'interventionNames': ['Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily']}, {'type': 'EXPERIMENTAL', 'label': '6 days', 'description': '6 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.', 'interventionNames': ['Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily']}, {'type': 'ACTIVE_COMPARATOR', 'label': '7 days', 'description': '7 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.', 'interventionNames': ['Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily']}], 'interventions': [{'name': 'Phenoxymethylpenicillin 1.2 MIE 4 times daily', 'type': 'DRUG', 'description': 'The intervention is the duration of treatment with phenoxymethylpenicillin from 3 to 7 days. Dose and frequency of the treatment is the same in the different arms.', 'armGroupLabels': ['3 days', '4 days', '5 days', '6 days', '7 days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9260', 'city': 'Gistrup', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Line Maj Jensen', 'role': 'CONTACT', 'email': 'lmj@dcm.aau.dk', 'phone': '+45 25 69 99 33'}], 'facility': 'The Research Unit for General Practice Aalborg', 'geoPoint': {'lat': 56.9943, 'lon': 9.99085}}], 'centralContacts': [{'name': 'Eskild Johansen, MD, Ph.d.-student', 'role': 'CONTACT', 'email': 'ejoha@dcm.aau.dk', 'phone': '+45 31 58 29 13'}, {'name': 'Malene Plejdrup Hansen, MD, Associate Professor', 'role': 'CONTACT', 'email': 'mph@dcm.aau.dk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Unit for General Practice in Aalborg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}