Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT03606135
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2018-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Nasopharyngeal samples (flocked swab), oral samples (flocked swab), urine and blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-02', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-07-27', 'lastUpdatePostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Distribution of different microbial findings in subjects with CAP including the proportion of co-infection and correlate with severity of disease', 'timeFrame': '10 days', 'description': 'To define the distribution of different microbial findings in subjects with CAP and estimate viral and bacterial load using semi-quantitive PCR and correlate it with severity of disease and calculate the proportion of subjects with co-infection.'}, {'measure': 'Difference in sensitivity in detection of bacterial agents, comparing sputum and nasopharyngeal sampling and comparing bacterial culture with PCR', 'timeFrame': '10 days', 'description': 'To define the difference in sensitivity in detection of bacterial agents, comparing sputum and nasopharyngeal sampling and comparing bacterial culture with PCR (Polymerase Chain Reaction).'}, {'measure': 'Distribution of nasopharyngeal microbial findings in subjects with CAP in comparison to an asymptomatic control group', 'timeFrame': '10 days', 'description': 'To determine differences in nasopharyngeal microbial findings in subjects with CAP and an asymptomatic control group.'}, {'measure': 'The microbiome in the respiratory tract in subjects initially diagnosed with CAP and after 3 months. The control group will be included.', 'timeFrame': '3 months', 'description': 'To determine the microbiome in the respiratory tract in subjects diagnosed with CAP and compare those microbiomes 3 months later. CAP subjects will be compared with the control group.'}, {'measure': 'Antibiotic resistance rate of bacterial isolates', 'timeFrame': '10 days', 'description': 'To estimate antibiotic resistance rates among bacterial isolates, other than S.pneumoniae.'}, {'measure': 'Correlation of antibiotic regimen, clinical outcome and readmission', 'timeFrame': '3 months', 'description': 'To calculate the correlation of antibiotic regimen, ICU, length-of-stay (LOS) and clinical outcome including mortality after 90 days in addition to readmission rate.'}, {'measure': 'Etiology and and outcome in patients with CAP and correlate it to the Charlson Comorbidity Index, CRB-65, and Pneumonia Severity Index', 'timeFrame': '3 months', 'description': 'Etiology and and outcome in patients with CAP and correlate it to the Charlson Comorbidity Index, CRB-65 (Confusion-Rate-Blood pressure, ≥65 years) and Pneumonia Severity Index'}, {'measure': 'Correlation between treatment with protein pump inhibitors and CAP', 'timeFrame': '10 days', 'description': 'To observe any correlation between CAP and treatment with protein pump inhibitors.'}, {'measure': 'Correlation of the levels of vitamin D and severity of CAP', 'timeFrame': '10 days', 'description': 'To correlate levels of vitamin D to severity of CAP'}, {'measure': 'New cognitive impairment at follow-up', 'timeFrame': '3 months', 'description': 'To determine which factors of MoCA (Montreal Cognitive Assessment) are associated with long-term cognitive impairment after hospitalization with pneumonia.'}, {'measure': 'Newly acquired functional disability of performing physical activities at follow-up', 'timeFrame': '3 months', 'description': 'To determine which factors of P-ADL (Physical Activities of Daily Living) are associated with functional decline after pneumonia.'}, {'measure': 'Newly acquired functional disability of performing instrumental activities at follow-up', 'timeFrame': '3 months', 'description': 'To determine which factors of I-ADL (Instrumental Activities of Daily Living) are associated with functional decline after pneumonia.'}, {'measure': 'Decline in quality of life from enrolment to follow-up', 'timeFrame': '3 months', 'description': 'To determine which factors of EQ-5D (European Quality of life - 5 Dimensions) are associated with declining quality of life after pneumonia.'}], 'primaryOutcomes': [{'measure': 'The proportion S.pneumoniae serotypes included in PCV13 (Pneumococcal conjugate vaccine) among adults ≥18 years of age presenting with radiographically-confirmed CAP.', 'timeFrame': '10 days', 'description': 'The overall proportion of subjects with clinically and radiographically-confirmed CAP who have PCV13 S.pneumoniae detected by either UAD assay and/or culture.'}], 'secondaryOutcomes': [{'measure': 'The S.pneumoniae serotype distribution form UAD and culture isolates.', 'timeFrame': '10 days', 'description': 'The full distribution of all S.pneumoniae serotypes among patients with CAP.'}, {'measure': 'The incidence rate of CAP and subjects with S.pneumoniae positive radiologically confirmed CAP (SP+CAP)', 'timeFrame': '10 days', 'description': 'The incidence rate of CAP and SP+CAP'}, {'measure': 'The differences in detection of S.pneumoniae by culture, BinaxNOW® and the UAD assay', 'timeFrame': '10 days', 'description': 'The overall proportion of SP+CAP subjects with S.pneumoniae identified by culture, BinaxNOW®, and/or either UAD assay.'}, {'measure': 'The proportion of subjects with CAP and with SP+CAP who present with underlying at-risk and high-risk medical conditions', 'timeFrame': '10 days', 'description': 'The proportion of subjects with CAP and SP+CAP who present with underlying at-risk and high-risk medical conditions.'}, {'measure': 'Antibiotic resistance rates among isolates of S.pneumoniae', 'timeFrame': '10 days', 'description': 'Antibiotic resistance rates among isolates of S.pneumoniae.'}, {'measure': 'Validation of the UAD assay in CAP patients and compare with controls', 'timeFrame': '10 days', 'description': 'To validate the UAD assay in CAP patients and compare results with the control group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pneumonia', 'Streptococcus pneumoniae', 'Incidence', 'Ethiology', 'Serotype'], 'conditions': ['Pneumonia']}, 'referencesModule': {'references': [{'pmid': '38152664', 'type': 'DERIVED', 'citation': 'Hansen K, Yamba Yamba L, Wasserstrom L, Runow E, Goransson T, Nilsson A, Ahl J, Riesbeck K. Exploring the microbial landscape: uncovering the pathogens associated with community-acquired pneumonia in hospitalized patients. Front Public Health. 2023 Dec 13;11:1258981. doi: 10.3389/fpubh.2023.1258981. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'This is an epidemiological study to investigate the etiology of radiographically-confirmed community-acquired pneumonia (CAP) in adults aged ≥18 years. The main objective is to determine the proportion of which cases that is due to Streptococcus pneumoniae and the corresponding incidence and serotype distribution. The study will utilize a serotype-specific urinary antigen detection (UAD) assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Pneumonia Group: Adults ≥ 18 years of age who present to the emergency room with signs and symptoms of CAP and have radiographic evidence of pneumonia, as read by the clinical radiologist on duty will be identified and enrolled. As this is an active, prospective surveillance study, all eligible subjects should be screened for enrolment, including whose who are admitted during nights.\n\nThe Control Group: Subjects will be sceened by the nurse at the orthopedic section of the emergency unit, since these patients are unlikely to have respiratory tract infections. Subjects will be chosen randomly and evenly over the whole duration of the study to get a representative control group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'The Pneumonia Group\n\nInclusion Criteria:\n\n* Age ≥ 18 years.\n* Present to a study healthcare facility where treating physician clinically suspects CAP with the presence of two or more of the following signs and symptoms: Fever, Hypothermia, Chills or rigors, Pleuritic chest pain, Cough, Sputum production, Dyspnea, Tachypnea, Malaise, Abnormal auscultatory findings suggestive of pneumonia.\n* Has radiographic finding that is consistent with pneumonia.\n* Able and willing to provide urine sample.\n* Signed and dated informed consent\n\nExclusion Criteria:\n\n* Transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility.\n* Hospital acquired pneumonia.\n* Subjects who are investigational staff members and their family members, and site staff members otherwise supervised by the investigator.\n* Previous enrollment in this study within the previous 30 days.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.\n\nThe Control Group\n\nInclusion Criteria:\n\n* Signed and dated informed consent.\n* Age ≥ 18 years.\n* Able and willing to provide urine sample.\n\nExclusion Criteria:\n\n* Subjects who are investigational staff members or relatives of those staff member or subjects who are Pfizer employees directly involved in the conduct of the study.\n* Subjects with suspicion of CAP or any other respiratory infectious disease, as well as evidence of or documented concomitant infectious disease.\n* Subjects residing in any long-term care facilities.\n* Subjects with known bronchial obstruction or history of post-obstructive pneumonia. Chronic obstructive pulmonary disease (COPD) is permissible, provided there has no been an exacerbation with 3 months prior to enrollment.\n* Subjects with primary lung cancer or another malignancy metastatic to the lungs.\n* Subjects with fever.\n* Subjects with significant immunosuppressive disease such as AIDS, leukemia, etc.\n* Subjects with either pneumococcal conjugate vaccine (PCV) and/or pneumococcal polysaccharide vaccine (PPV) administration within the past 30 days.'}, 'identificationModule': {'nctId': 'NCT03606135', 'acronym': 'OSPIS', 'briefTitle': 'Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP)', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP) in Adults ≥ 18 Years (OSPIS)', 'orgStudyIdInfo': {'id': '2016/220'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The Pneumonia Group', 'description': 'Subjects with chest images (x-ray or CT scan) indicating pneumonia.', 'interventionNames': ['Other: The Pneumonia Group']}, {'label': 'The Control Group', 'description': 'Healthy subjects', 'interventionNames': ['Other: The Control Group']}], 'interventions': [{'name': 'The Pneumonia Group', 'type': 'OTHER', 'armGroupLabels': ['The Pneumonia Group']}, {'name': 'The Control Group', 'type': 'OTHER', 'armGroupLabels': ['The Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20502', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Jonas Ahl, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Infectious Diseases'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}