Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP) (OSPIS)

R

Region Skane

Status

Completed

Conditions

Pneumonia

Treatments

Other: The Pneumonia Group
Other: The Control Group

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03606135
2016/220

Details and patient eligibility

About

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.

Enrollment

600 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

600 participants in 2 patient groups

The Pneumonia Group
Description:
Subjects with chest images (x-ray or CT scan) indicating pneumonia.
Treatment:
Other: The Pneumonia Group
The Control Group
Description:
Healthy subjects
Treatment:
Other: The Control Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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