Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT03606135
Eligibility Criteria:
The Pneumonia Group
Inclusion Criteria:
* 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
Exclusion Criteria:
* Transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility.
* Hospital acquired pneumonia.
* Subjects who are investigational staff members and their family members, and site staff members otherwise supervised by the investigator.
* Previous enrollment in this study within the previous 30 days.
* 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.
The Control Group
Inclusion Criteria:
* Signed and dated informed consent.
* Age ≥ 18 years.
* Able and willing to provide urine sample.
Exclusion Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03606135
Study Brief:
Protocol Section:
NCT03606135