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Trial record 82 of 759 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

A Sputum Screening Test to Rule-out Pneumonia at an Early Stage (self-test)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03256604
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : August 22, 2017
Linkoeping University
PEAS Institut
Information provided by (Responsible Party):
Fariba Nayeri, University Hospital, Linkoeping

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.

Condition or disease Intervention/treatment
Pneumonia Community-acquired Pneumonia Exacerbation Copd Diagnostic Test: left-over sputum

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 467 participants
Observational Model: Cohort
Time Perspective: Retrospective
Actual Study Start Date : November 2015
Actual Primary Completion Date : February 5, 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
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
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.

Primary Outcome Measures :
  1. Negative predictive value to rule-out pneumonia [ Time Frame: Within two years ]

    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.

Secondary Outcome Measures :
  1. Correlation to HGF and S100A8-A9 (Calprotectin) concentration (Elisa) in sputum [ Time Frame: The samples were kept frozen after sampling -20 C and then thawed after 4 months and analyse was performed within 1 day. ]
    We assessed immunoreactive human HGF and calprotectin (Human S100A8/S100A9 heterodimer) concentrations by ELISA (80 randomly chosen samples) using commercially available ELISA kits (Quantikine ELISA; R&D systems, Inc., Minneapolis, MN, USA). This method measures HGF and calprotectin in serum, plasma, culture media, and other biological fluids. Sputum samples that had been stored -20C were thawed and centrifuged at 1000 g for 10 minutes prior to analysis. The minimum detectable dose (MDD) as defined by supplier for this assay was 0.04 ng/ml for HGF and 0.086 ng/ml for calprotectin.

  2. Correlation to binding affinity to the parts of HGF molecule by Surface plasmon resonance [ Time Frame: in 47 samples paired Elisa and SPR analysis was performed on samples kept in -20 C within 4 months after sampling.. ]
    Paired analysis was performed on 47 randomly chosen samples. Measurements and ligand immobilization procedures were conducted using a Biacore 2000 system (GE Healthcare Bio-Sciences AB, Uppsala, Sweden). Three different ligands were immobilized in separate channels on the SPR-chip. The ligands were affinity purified polyclonal antibodies directed against HGF peptides mapping at the N-terminus of human HGFβ (N-19), the N-terminus of human HGFα (N-17), and amino acids 32-176 of human HGFα (H-145). These ligands were diluted 1:10 in 10 mM acetate buffer (pH 4.5) and immobilized to carboxymethylated dextran CM5 chips

Other Outcome Measures:
  1. The management routine for pneumonia at Infectious clinic in Linkoeping in last decades [ Time Frame: 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 ]
    We studied the archived paper journals from patients that were admitted to our ward and dismissed under diagnosis pneumonia/bronchopneumonia, beginning in 1970. We aimed to identify the diagnostic approaches that were used at the same center and had an impact on the correct diagnosis of pneumonia. Patients received a code depending on the date of admission to the ward from January-December and were registered under the code in a book. The codes belonging to a particular diagnosis were collected on a card and kept separately in boxes (one card corresponded to one diagnosis and one year). We randomly chose the first 40 coded cases with a diagnosis of Pneumonia (ICD-9 diagnosis code 486.9) in 1970, 1980, and 1990 and collected the paper journals and identified the criteria for diagnosis.

Biospecimen Retention:   Samples Without DNA
Sputum samples from all included cases are kept frozen -70 C coded.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Samples not collected as above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03256604

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Department of Infectious Diseases
Linköping, Östergotland, Sweden, 58185
Sponsors and Collaborators
University Hospital, Linkoeping
Linkoeping University
PEAS Institut

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Responsible Party: Fariba Nayeri, PhD, MD, associated professor, University Hospital, Linkoeping Identifier: NCT03256604     History of Changes
Other Study ID Numbers: Dexact-resp
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information regarding the samples that were included in statistic calculations, excluded cases with infection, pneumonia 1970-1980-1990, the actual cost of tests performed at our centre for diagnosis of pneumonia and the volunteers joining the feasibility test in Tables A-L
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data is available and awaiting the URL address to be defined.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fariba Nayeri, University Hospital, Linkoeping:
point of care, HGF, innate immunity
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections