A Sputum Screening Test to Rule-out Pneumonia at an Early Stage

NCT03256604 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 467

Last updated 2017-08-22

No results posted yet for this study

Summary

In patients with clinical symptoms of respiratory infection, rapid identification of cases requiring antibiotic therapy is crucial to avoid development of multiple resistant bacteria. Identification of local acute-phase reactants can help assess the host's response to bacterial infection at the injury site. Here, the investigators developed an affordable, stable, feasible, and accurate diagnostic tool based on a locally produced protein with specific binding affinity to polysaccharides. The investigators further evaluated the ability of the novel test strip to rule out pneumonia.

Conditions

  • Pneumonia
  • Community-acquired Pneumonia
  • Exacerbation Copd

Interventions

DIAGNOSTIC_TEST

left-over sputum

Totally 467 samples were gathered from different clinics, and the diagnostic procedures and the therapeutic approaches were completely unknown to the study group. The coded samples were stored at 4-8°C and analyzed within 72 hours of sampling using the sputum strip test. From April to June 2016, a physician and the study nurse reviewed the journals. The age, sex, length of stay on ward, the clinical symptoms, the blood and sputum cultures and PCR along with the results, the X-rays, the antibiotic therapy, CRB-65 and the ultimate diagnosis code (ICD-10) were documented in Excel-files.

Sponsors & Collaborators

  • Linkoeping University

    collaborator OTHER_GOV
  • PEAS Institut

    collaborator UNKNOWN
  • University Hospital, Linkoeping

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-02-05
Completion
2016-04-30

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03256604 on ClinicalTrials.gov