NCT03606135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

2.3 years

First QC Date

July 9, 2018

Last Update Submit

April 2, 2020

Conditions

Pneumonia

Keywords

PneumoniaStreptococcus pneumoniaeIncidenceEthiologySerotype

Outcome Measures

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.

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

    10 days

Secondary Outcomes (6)

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

    10 days

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

    10 days

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

    10 days

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

    10 days

  • Antibiotic resistance rates among isolates of S.pneumoniae

    10 days

  • +1 more secondary outcomes

Other Outcomes (13)

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

    10 days

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

    10 days

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

    10 days

  • +10 more other outcomes

Study Arms (2)

The Pneumonia Group

Subjects with chest images (x-ray or CT scan) indicating pneumonia.

Other: The Pneumonia Group

The Control Group

Healthy subjects

Other: The Control Group

Interventions

The Pneumonia GroupOTHER
The Pneumonia Group
The Control GroupOTHER
The Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Signed and dated informed consent.
  • Age ≥ 18 years.
  • Able and willing to provide urine sample.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital

Malmo, 20502, Sweden

Location

Related Publications (1)

  • Hansen K, Yamba Yamba L, Wasserstrom L, Runow E, Goransson T, Nilsson A, Ahl J, Riesbeck K. Exploring the microbial landscape: uncovering the pathogens associated with community-acquired pneumonia in hospitalized patients. Front Public Health. 2023 Dec 13;11:1258981. doi: 10.3389/fpubh.2023.1258981. eCollection 2023.

    PMID: 38152664DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal samples (flocked swab), oral samples (flocked swab), urine and blood.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jonas Ahl, MD, PhD

    Department of Infectious Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 30, 2018

Study Start

September 17, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 3, 2020

Record last verified: 2020-04

Locations

SE(1)