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Usefulness of C-reactive Protein Testing in Acute Cough

16. februar 2013 opdateret af: Northern State Medical University

The Usefulness of Point-of-care-testing for C-reactive Protein in Lower Respiratory Tract Infection or Acute Cough

The aim of this study is to evaluate the usefulness in Russian general practice of C-reactive protein testing in patients with acute cough or lower respiratory tract infections.

In addition to studying the effect of C-reactive protein testing on the prescription of antibiotics, the purpose is to find out whether the frequency of referral to radiography could be reduced.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Eighteen general practitioners, from both urban and rural offices, were randomised into intervention and control groups. All registrations were made by general practitioners in their offices.

The case report form was similar to that used in the GRACE study (Genomics to combat Resistance against Antibiotics in Community-acquired lower respiratory tract infections in Europe (www.grace-lrti.org) describing symptoms, findings, and treatment in lower respiratory tract infections.

  • The clinical examination included a chest examination and the axillary temperature.
  • After the clinical examination, the general practitioners recorded their provisional diagnosis.
  • Chest radiography was accessible for all patients.

The C-reactive protein test was performed in the intervention group at both the first and second consultations. The Afinion test system was used, which provides results within 5 minutes and before treatment was determined. This test is based on solid-phase sandwich immunometric analysis.

General practitioners could prescribe any treatment, including antibiotics and other drugs for the cough and additional medication if deemed necessary.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

179

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • patients with lower respiratory tract infections/acute cough (including acute bronchitis, pneumonia, and infectious exacerbations of chronic obstructive pulmonary disease or asthma),
  • age 18 years or older,
  • an illness of less than 28 days duration,
  • first consultation for the illness episode,
  • being seen in a physician's office,
  • written consent to participate.

Exclusion Criteria:

  • an inability to fill out study documentation,
  • being previously included in the study,
  • immunocompromised status (HIV patients, immunosuppressive treatment),
  • ongoing treatment with oral corticosteroids

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: C-reactive protein test

The C-reactive protein test was performed in the intervention group at both the first and second consultations.

The Afinion test system (Axis Shield) was used, which provides results within 5 minutes and before treatment was determined. This test is based on solid-phase sandwich immunometric analysis. The measurement range in whole blood samples is 8-200 mg/L.
Enhed: C-reactive protein test
Results provides within 5 minutes. This test is based on solid-phase sandwich immunometric analysis. The measurement range in whole blood samples is 8-200 mg/L.
Andre navne:
  • The Afinion test system (Axis Shield)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
the antibiotic prescribing rate
Tidsramme: within the first 2 weeks after first consultation
within the first 2 weeks after first consultation

Sekundære resultatmål

Resultatmål
Tidsramme
referral to radiography
Tidsramme: within the first 2 weeks after first consultation
within the first 2 weeks after first consultation

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
rate of recovery at the follow-up consultation
Tidsramme: within the first 2 weeks after first consultation
Rate of recovery at the follow-up consultation after 2 weeks with the following five alternatives: "fully recovered", "almost recovered", "slightly improved", "unchanged", and "worse". Consultations with the general practitioner within 2 weeks and complications (in need of hospitalisation) were recorded.
within the first 2 weeks after first consultation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Northern State Medical University

Samarbejdspartnere

University of Tromso

Efterforskere

  • Studiestol: Hasse Melbye, PhD, University of Tromsø, Department of Community Medicine
  • Ledende efterforsker: Elena A Andreeva, MD, MPH, Northern State Medical University, Family Medicine Department

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2010

Primær færdiggørelse (Faktiske)

1. april 2010

Studieafslutning (Faktiske)

1. april 2010

Datoer for studieregistrering

Først indsendt

16. februar 2013

Først indsendt, der opfyldte QC-kriterier

16. februar 2013

Først opslået (Skøn)

20. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. februar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. februar 2013

Sidst verificeret

1. februar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRP-ARK-01/10

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Luftvejsinfektioner

Kliniske forsøg med C-reactive protein test

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner