Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP)
NCT03606135
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Age ≥ 18 years.
- 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.
- Has radiographic finding that is consistent with pneumonia.
- Able and willing to provide urine sample.
- Signed and dated informed consent
- 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.
- Subjects with suspicion of CAP or any other respiratory infectious disease, as well as
evidence of or documented concomitant infectious disease.
- Subjects residing in any long-term care facilities.
- 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.
- Subjects with primary lung cancer or another malignancy metastatic to the lungs.
- Subjects with fever.
- Subjects with significant immunosuppressive disease such as AIDS, leukemia, etc.
- Subjects with either pneumococcal conjugate vaccine (PCV) and/or pneumococcal
polysaccharide vaccine (PPV) administration within the past 30 days.
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Descriptive Information | |||||
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Brief Title | Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP) | ||||
Official Title | Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP) in Adults ? 18 Years (OSPIS) | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: Nasopharyngeal samples (flocked swab), oral samples (flocked swab), urine and blood. | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | 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. The 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. | ||||
Condition | Pneumonia | ||||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment | 600 | ||||
Original Estimated Enrollment | Same as current | ||||
Actual Study Completion Date | December 31, 2018 | ||||
Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | The Pneumonia Group Inclusion Criteria:
Exclusion Criteria:
The Control Group Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Sweden | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03606135 | ||||
Other Study ID Numbers | 2016/220 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Region Skane | ||||
Study Sponsor | Region Skane | ||||
Collaborators | Pfizer | ||||
Investigators |
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PRS Account | Region Skane | ||||
Verification Date | April 2020 |