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Completed

NCT Number: NCT03606135

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

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Skåne University Hospital

Malmö, 20502, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Pneumonia Group

Other

The control group

Other

Primary outcomes

  1. The proportion S.pneumoniae serotypes included in PCV13 (Pneumococcal conjugate vaccine) among adults ≥18 years of age presenting with radiographically-confirmed CAP.

    Time frame: 10 days

    The overall proportion of subjects with clinically and radiographically-confirmed CAP who have PCV13 S.pneumoniae detected by either UAD assay and/or culture.

Secondary outcomes

  1. The S.pneumoniae serotype distribution form UAD and culture isolates.

    Time frame: 10 days

    The full distribution of all S.pneumoniae serotypes among patients with CAP.

  2. The incidence rate of CAP and subjects with S.pneumoniae positive radiologically confirmed CAP (SP+CAP)

    Time frame: 10 days

    The incidence rate of CAP and SP+CAP

  3. The differences in detection of S.pneumoniae by culture, BinaxNOW® and the UAD assay

    Time frame: 10 days

    The overall proportion of SP+CAP subjects with S.pneumoniae identified by culture, BinaxNOW®, and/or either UAD assay.

  4. The proportion of subjects with CAP and with SP+CAP who present with underlying at-risk and high-risk medical conditions

    Time frame: 10 days

    The proportion of subjects with CAP and SP+CAP who present with underlying at-risk and high-risk medical conditions.

  5. Antibiotic resistance rates among isolates of S.pneumoniae

    Time frame: 10 days

    Antibiotic resistance rates among isolates of S.pneumoniae.

  6. Validation of the UAD assay in CAP patients and compare with controls

    Time frame: 10 days

    To validate the UAD assay in CAP patients and compare results with the control group.

Other outcomes

  1. Distribution of different microbial findings in subjects with CAP including the proportion of co-infection and correlate with severity of disease

    Time frame: 10 days

    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.

  2. Difference in sensitivity in detection of bacterial agents, comparing sputum and nasopharyngeal sampling and comparing bacterial culture with PCR

    Time frame: 10 days

    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).

  3. Distribution of nasopharyngeal microbial findings in subjects with CAP in comparison to an asymptomatic control group

    Time frame: 10 days

    To determine differences in nasopharyngeal microbial findings in subjects with CAP and an asymptomatic control group.

  4. The microbiome in the respiratory tract in subjects initially diagnosed with CAP and after 3 months. The control group will be included.

    Time frame: 3 months

    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.

  5. Antibiotic resistance rate of bacterial isolates

    Time frame: 10 days

    To estimate antibiotic resistance rates among bacterial isolates, other than S.pneumoniae.

  6. Correlation of antibiotic regimen, clinical outcome and readmission

    Time frame: 3 months

    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.

  7. Etiology and and outcome in patients with CAP and correlate it to the Charlson Comorbidity Index, CRB-65, and Pneumonia Severity Index

    Time frame: 3 months

    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

  8. Correlation between treatment with protein pump inhibitors and CAP

    Time frame: 10 days

    To observe any correlation between CAP and treatment with protein pump inhibitors.

  9. Correlation of the levels of vitamin D and severity of CAP

    Time frame: 10 days

    To correlate levels of vitamin D to severity of CAP

  10. New cognitive impairment at follow-up

    Time frame: 3 months

    To determine which factors of MoCA (Montreal Cognitive Assessment) are associated with long-term cognitive impairment after hospitalization with pneumonia.

  11. Newly acquired functional disability of performing physical activities at follow-up

    Time frame: 3 months

    To determine which factors of P-ADL (Physical Activities of Daily Living) are associated with functional decline after pneumonia.

  12. Newly acquired functional disability of performing instrumental activities at follow-up

    Time frame: 3 months

    To determine which factors of I-ADL (Instrumental Activities of Daily Living) are associated with functional decline after pneumonia.

  13. Decline in quality of life from enrolment to follow-up

    Time frame: 3 months

    To determine which factors of EQ-5D (European Quality of life - 5 Dimensions) are associated with declining quality of life after pneumonia.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Pfizer

Registry information

Official study title

Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP) in Adults ≥ 18 Years (OSPIS)

Acronym: OSPIS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 30, 2018
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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