- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01794819
Usefulness of C-reactive Protein Testing in Acute Cough
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Arkhangelsk, Russische Föderation, 163000
- Northern State Medical University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
the antibiotic prescribing rate
Zeitfenster: within the first 2 weeks after first consultation
|
within the first 2 weeks after first consultation
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
referral to radiography
Zeitfenster: within the first 2 weeks after first consultation
|
within the first 2 weeks after first consultation
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
rate of recovery at the follow-up consultation
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Hasse Melbye, PhD, University of Tromsø, Department of Community Medicine
- Hauptermittler: Elena A Andreeva, MD, MPH, Northern State Medical University, Family Medicine Department
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Smedemark SA, Aabenhus R, Llor C, Fournaise A, Olsen O, Jorgensen KJ. Biomarkers as point-of-care tests to guide prescription of antibiotics in people with acute respiratory infections in primary care. Cochrane Database Syst Rev. 2022 Oct 17;10(10):CD010130. doi: 10.1002/14651858.CD010130.pub3.
- Andreeva E, Melbye H. Usefulness of C-reactive protein testing in acute cough/respiratory tract infection: an open cluster-randomized clinical trial with C-reactive protein testing in the intervention group. BMC Fam Pract. 2014 May 2;15:80. doi: 10.1186/1471-2296-15-80.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CRP-ARK-01/10
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Infektionen der Atemwege
-
Venus MedTech (HangZhou) Inc.Noch keine RekrutierungNative Right Ventricle Outflow Tract(RVOT) Dysfunction
-
Maastricht University Medical CenterWingate Institute of NeurogastroenterologyRekrutierungfMRT | Transkutane Vagusnervstimulation (tVNS) | Kern des Solitary Tract (NTS)Niederlande, Vereinigtes Königreich
-
Jianfeng XieRekrutierungCLABSI – Central Line Associated Bloodstream InfectionChina
-
University of BariRekrutierungInfektionen | Gastroenteric Tract | Atemwege | Gastroenterische InfektionenItalien
-
Nicola IrwinAbgeschlossenRespiratory-Syncytial-Virus-Krankenhausaufenthalte | Respiratory-Syncytial-Virus-Prävention | Respiratory Syncytial Virus (RSV)-InfektionAustralien
-
Assiut UniversityNoch keine RekrutierungCLABSI – Central Line Associated Bloodstream Infection | Peripher eingeführter Zentralkatheter | Nabelschnur venöser Katheter
-
Duke UniversityAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Vereinigte Staaten
-
Catholic University of the Sacred HeartAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Nicola IrwinThe University of New South Wales; Kirby InstituteAbgeschlossenRespiratory-Syncytial-Virus-Krankenhausaufenthalte | Infektion mit dem Respiratory Syncytial Virus (RSV). | Immunisierung gegen respiratorische SynzytialvirenAustralien
-
MAXVAX Biotechnology Limited Liability CompanyHenan Center for Disease Control and PreventionNoch keine Rekrutierung
Klinische Studien zur C-reactive protein test
-
University Medical Center GroningenUMC Utrecht; Leiden University Medical Center; ZonMw: The Netherlands Organisation...RekrutierungBlinddarmentzündung akut | Akutes Abdomen bei KindernNiederlande
-
Rigshospitalet, DenmarkNational Center of Cardiology and Internal Medicine named after academician... und andere MitarbeiterAbgeschlossenInfektionen der Atemwege | Antibiotika Resistenz | Pädiatrische Infektionskrankheit | CRPKirgistan
-
Moroccan Society of SurgeryRekrutierungAnastomoseninsuffizienz | Neoplasma des Verdauungssystems | C-reaktives ProteinMarokko
-
Sisli Hamidiye Etfal Training and Research HospitalAbgeschlossenNeugeborenes; Infektion | Neugeborene SepsisTruthahn
-
Henning BliddalAbgeschlossen
-
Central Hospital, Nancy, FranceAbgeschlossenMorbus CrohnFrankreich
-
Corporacion Parc TauliUnbekannt
-
Sohag UniversityRekrutierung
-
Zagazig UniversityAbgeschlossen
-
Centre Hospitalier Intercommunal CreteilAssociation Nationale des Hépato-Gastroentérologues des Hôpitaux GénérauxSuspendiert