- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Arkhangelsk, 러시아 연방, 163000
- Northern State Medical University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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the antibiotic prescribing rate
기간: within the first 2 weeks after first consultation
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within the first 2 weeks after first consultation
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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referral to radiography
기간: within the first 2 weeks after first consultation
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within the first 2 weeks after first consultation
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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rate of recovery at the follow-up consultation
기간: within the first 2 weeks after first consultation
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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.
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within the first 2 weeks after first consultation
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공동 작업자 및 조사자
수사관
- 연구 의자: Hasse Melbye, PhD, University of Tromsø, Department of Community Medicine
- 수석 연구원: Elena A Andreeva, MD, MPH, Northern State Medical University, Family Medicine Department
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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