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

NCT03256604 | Completed

• 1 other identifier: Dexact-resp
• Study Type: observational
• Target: 467
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

point of care, HGF, innate immunity

Outcome Measures

Primary Outcomes (1)

• Negative predictive value to rule-out pneumonia

  The sputum samples were collected randomly without knowledge about the patient or the ultimate diagnosis. The diagnoses were established first after the patient was dismissed from the clinic. RESPIRATORY INFECTION Pneumonia The following criteria were used to define pneumonia diagnosis 1. Clinical signs and symptoms 2. Changes detected by recent chest radiography 3. Received antibiotic therapy, irrespective previous antibiotic consumption. 4. The ultimate diagnosis J13-J18-J690 (ICD-10). Community-acquired pneumonia: The patients without previous respiratory disease. Hospital acquired (Nosocomial) pneumonia: Patients (n=11) acquired pneumonia at the hospital at least 48-72 hours after being admitted.

  Within two years

Secondary Outcomes (2)

• Correlation to HGF and S100A8-A9 (Calprotectin) concentration (Elisa) in sputum

  The samples were kept frozen after sampling -20 C and then thawed after 4 months and analyse was performed within 1 day.

• Correlation to binding affinity to the parts of HGF molecule by Surface plasmon resonance

  in 47 samples paired Elisa and SPR analysis was performed on samples kept in -20 C within 4 months after sampling..

Other Outcomes (1)

• The management routine for pneumonia at Infectious clinic in Linkoeping in last decades

  The data was obtained from paper journals from patients that were admitted (December to March) to the Department of Infectious diseases in Linköping in 1970,1980 and1990

Study Arms (1)

Fresh left-over sputum

All fresh sputum samples that were sent to the Department of Microbiology between November 1 2015 and January 30 2016 under the standard requirements for sputum cultures at the accredited (ISO 17025 and 15189 beginning in 1993) laboratory were kept cold (4-8 ͦC) after analysis by microscope and cultures until it was collected and coded by the study nurse in the evening (left-over samples).

Diagnostic Test: left-over sputum

Interventions

left-over sputum DIAGNOSTIC_TEST

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.

Fresh left-over sputum

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All cases that searched the open Health care specialist facility at Linkoeping University hospital or were admitted to the ward at different clinics at the University Hospital in Linkoeping between 1st November 2015 to 30th January 2016 due to suspected respiratory infection and sputum samples were collected to be cultured at the Department of Microbiology University Hospital in Linkoeping.

You may qualify if:

• Sputum samples collected for routine diagnostic and reached the laboratory within 12 hours after Collection and considered as representative by microscopy and kept 4-8 C after Culture.

You may not qualify if:

• Samples not collected as above

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Linkoeping University: collaborator
• PEAS Institut: collaborator

Study Sites (1)

Department of Infectious Diseases

Linköping, Östergotland, 58185, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum samples from all included cases are kept frozen -70 C coded.

MeSH Terms

Conditions

Pneumonia; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Community-Acquired Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD, associated professor

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 22, 2017
• Study Start: November 1, 2015
• Primary Completion: February 5, 2016
• Study Completion: April 1, 2016
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data is available and awaiting the URL address to be defined.

Locations

SE (1)