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

NCT03606135

Last updated date
Study Location
Skåne University Hospital
Malmö, , 20502, Sweden
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Other: The Pneumonia Group
  • Other: The Control Group
Study Groups/Cohorts
  • The Pneumonia Group
    Subjects with chest images (x-ray or CT scan) indicating pneumonia.
    Intervention: Other: The Pneumonia Group
  • The Control Group
    Healthy subjects
    Intervention: Other: The Control Group
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
 (submitted: July 27, 2018)
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:

  • 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.
Sex/Gender
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:Undecided
Responsible Party Region Skane
Study Sponsor Region Skane
Collaborators Pfizer
Investigators
Principal Investigator:Jonas Ahl, MD, PhDDepartment of Infectious Diseases
PRS Account Region Skane
Verification Date April 2020