Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT03315403
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2017-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative Polymerase Chain Reaction for Improved Detection of Pneumococci in CAP "CAPTAIN"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011018', 'term': 'Pneumonia, Pneumococcal'}, {'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], 'ancestors': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D017714', 'term': 'Community-Acquired Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Collection of nasopharynx, oropharynx, saliva, sputum and blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 922}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-07', 'studyFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2017-10-19', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'qPCR diagnosed pneumococcal pneumonia', 'timeFrame': '1 day, day of inclusion', 'description': 'Occurrence of qPCR proven pneumococcal pneumonia (CAP with S. pneumoniae detected by qPCR in at least one of the samples with a positive lytA qPCR and a DNA copy number above the determined cut-off value) using the cut-off value in at least one of the specimens at inclusion. The cut-off value will be determined in this study, see secondary objective.'}, {'measure': 'Pneumococcal pneumonia with usual tests', 'timeFrame': '1 day, day of inclusion', 'description': 'Occurrence of pneumococcal pneumonia proven by at least one of the routine microbiological tests (urine antigen test, blood culture and/or sputum culture). The difference between outcome measure 1 and 2 is the added diagnostic value.'}], 'secondaryOutcomes': [{'measure': 'Number of DNA copies of S. pneumoniae in all lytA qPCR positive study subjects', 'timeFrame': '1 day, day of inclusion', 'description': 'The number of DNA copies of every study subject with a positive qPCR will be determined. The optimal cut-off value will be determined to distinguish between colonisation and infection by comparing the number of DNA copies of controls with a positive lytA PCR and patients with a pneumococcal pneumonia proven by routine microbiological tests. This cut-off value will be used for outcome measure 1 to determine the amount of patients with an qPCR proven pneumococcal pneumonia.'}, {'measure': 'Occurrence of positive lytA qPCR at 30 days after inclusion in CAP patients', 'timeFrame': '30 days', 'description': 'Occurrence of positive lytA qPCR at 30 days after inclusion in CAP patients in the different samples: oropharynx, nasopharynx, saliva and sputum.'}, {'measure': 'CURB-65 scores', 'timeFrame': '1 day, day of inclusion', 'description': 'CURB-65 scores will be determined in CAP patients at moment of inclusion.'}, {'measure': 'Procalcitonin', 'timeFrame': '1 day, day of inclusion', 'description': 'Procalcitonin levels will be determined in CAP patients at moment of inclusion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quantitative polymerase chain reaction', 'qPCR', 'autolysin', 'lytA', 'Pneumococcal pneumonia', 'Diagnostics', 'Community-acquired Pneumonia', 'Antibiotic resistance'], 'conditions': ['Pneumonia, Pneumococcal', 'Community-acquired Pneumonia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the added diagnostic value of a quantitative polymerase chain reaction targeting the lytA gene in detecting pneumococci in patients with community-acquired pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient group: Adult patients ≥18 years with diagnosis of CAP at the emergency department (ED).\n\nControl groups (without CAP):\n\n* Related controls (inclusion at ED)\n* Unrelated healthy adults (inclusion at an outpatient preoperative appointment for any elective surgery)\n* Stable COPD patients (inclusion at outpatient clinic for pulmonary diseases)\n* COPD patients with an AECOPD (inclusion at ED)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients:\n\n* Age 18 years or above;\n* Presentation at the emergency department (ED);\n* Working diagnosis of CAP at the ED with the presence of at least two of the following criteria:\n\n 1. New or worsened coughing;\n 2. Production of purulent sputum or change in sputum colour;\n 3. Temperature \\>38.0 ⁰C or ≤36.0 ⁰C (tympanic);\n 4. Auscultatory findings consistent with pneumonia, including rales, evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, rales, or egophony), or both;\n 5. White blood cell count of \\>10x10\\^9 cells/L or \\<4x10\\^9 cells/L or \\>15% bands;\n 6. C-reactive protein level ≥30mg/L;\n 7. Dyspnea, tachypnea, (\\>20 breaths per minute), or hypoxemia (arterial pO2 \\<60mmHg or peripheral O2 saturation \\<90%).\n* New consolidation(s) on the chest radiograph or computed tomography (CT);\n* No other explanation for the signs and symptoms;\n\nControl group 1 - Related controls\n\n* Being aged 18 years or above;\n* Close relative of the patient: relative defined as living in the same house as the CAP patient or daily contact;\n* Is at the hospital at the moment of inclusion of the CAP patient or is willing to come for testing within 7 days;\n\nControl group 2 - Unrelated healthy individuals\n\n* Being aged 18 years or above;\n* Subject with a preoperative appointment with the anaesthiologist for a planned surgical procedure;\n* Age matched to a included CAP patient (+-10 years);\n* Time matched to a included CAP patient (up to 14 days after inclusion of the CAP patient);\n* Gender matched to a included CAP patient.\n\nControl group 3 - Patients with stable COPD\n\n* Being aged 18 years or above;\n* Diagnosis of COPD confirmed with spirometry (GOLD criteria 2017)(76);\n* Stable disease.\n\nControl group 4 - Patients with exacerbation of COPD\n\n* Being aged 18 years or above;\n* Diagnosis of COPD confirmed with spirometry (GOLD criteria 2017)(76);\n* Diagnosis of exacerbation of COPD: defined as an acute event characterised by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication (76).\n* Presentation at emergency department with the suspicion of an exacerbation.\n\nExclusion Criteria:\n\nIn general:\n\n* Recent pneumonia (\\< 1 month) or pneumonia in last 3 months with known pneumococcal aetiology with one of current diagnostics;\n* Was included in the study group before;\n* Not capable of understanding information needed to sign informed consent.\n\nPatients:\n\n* Aspiration pneumonia;\n* Hospitalisation for two or more days in the last 14 days;\n* History of cystic fibrosis.\n\nFor all control groups:\n\n* Fits inclusion criteria for patient group;\n* Present or recent hospitalisation (14 days);\n* Fits inclusion criteria for patient group;\n* Use of antibiotics in the last 14 days, including maintenance antibiotic therapy.\n\nControl group 1 and 2 - Related healthy controls and unrelated healthy individuals\n\n* Active infectious respiratory complaints defined as defined as two or more respiratory symptoms (cough, nasal congestion, runny nose, sore throat or sneezes);\n* Temperature \\>38.0 ⁰C;\n* Fits inclusion criteria for control group 3 or 4;\n* Chronic pulmonary disease: COPD, asthma, cystic fibrosis, bronchiectasis.\n\nControl group 3 - Patients with stable COPD\n\n* Temperature \\>38.0 ⁰C;\n* Stable disease;\n* Fits inclusion criteria for control group 4;\n* Recent exacerbation (\\<1 month) defined as increased respiratory symptoms with need of antibiotic and/or corticosteroid therapy;\n* History of cystic fibrosis.\n\nControl group 4 - Patients with exacerbation of COPD\n\n* Current pneumonia;\n* Recent exacerbation (\\<1 month) defined as increased respiratory symptoms with need of antibiotic and/or corticosteroid therapy;\n* Fits inclusion criteria for control group 3;\n* History of cystic fibrosis."}, 'identificationModule': {'nctId': 'NCT03315403', 'acronym': 'CAPTAIN', 'briefTitle': 'Quantitative Polymerase Chain Reaction for Improved Detection of Pneumococci in CAP "CAPTAIN"', 'organization': {'class': 'OTHER', 'fullName': 'Medical Center Alkmaar'}, 'officialTitle': 'Community-Acquired Pneumonia: lytA TArgeted Real Time Quantitative Polymerase chaIN Reaction for Improved Detection of Pneumococci (CAPTAIN)', 'orgStudyIdInfo': {'id': '63200'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with CAP', 'description': 'Patients with a diagnosis of radiographically-confirmed CAP at the emergency department will undergo the usual diagnostics. For the study an extra nasopharynx sample, saliva sample and blood sample will be collected.\n\nA questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available)', 'interventionNames': ['Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)']}, {'label': 'Related controls', 'description': 'Of related controls a nasopharynx sample, oropharynx sample and saliva sample will be collected.\n\nA questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva)', 'interventionNames': ['Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)']}, {'label': 'Unrelated controls', 'description': 'Of unrelated controls a nasopharynx sample, oropharynx sample and saliva sample will be collected.\n\nA questionnaire will be filled in. LytA PCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva)', 'interventionNames': ['Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)']}, {'label': 'Patients with stable COPD', 'description': 'Of stable COPD patients a nasopharynx sample, oropharynx sample and saliva sample will be collected. And if available also a sputum sample.\n\nA questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available)', 'interventionNames': ['Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)']}, {'label': 'Patients with exacerbation of COPD', 'description': 'Of patients with a diagnosis of an exacerbation of COPD at the emergency department a nasopharynx sample, oropharynx sample and saliva sample will be collected apart from the usual diagnostics. If available also a sputum sample will be collected.\n\nA questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available)', 'interventionNames': ['Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)']}], 'interventions': [{'name': 'LytA targeted quantitative polymerase chain reaction (qPCR)', 'type': 'DIAGNOSTIC_TEST', 'description': 'LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available)', 'armGroupLabels': ['Patients with CAP', 'Patients with exacerbation of COPD', 'Patients with stable COPD', 'Related controls', 'Unrelated controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haarlem', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Spaarne Gasthuis', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Noordwest Ziekenhuisgroep', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}], 'overallOfficials': [{'name': 'Wim Boersma, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Noordwest Ziekenhuisgroep'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Center Alkmaar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. PhD. Pulmonologist', 'investigatorFullName': 'W.G.Boersma', 'investigatorAffiliation': 'Medical Center Alkmaar'}}}}