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Comparison of a Serum PRO-CT Guided Treatment and the Recommended Antibiotic Treatment for COPD

2014年12月9日 更新者：Leonardo M. Fabbri、University of Modena and Reggio Emilia

Comparison of a Serum Procalcitonin (PRO-CT) Guided Treatment Plan With the Standard Guideline Recommended Antibiotic Treatment Plan for Patients Hospitalized With a Diagnosis of Exacerbation of COPD

Exacerbations of chronic obstructive pulmonary disease (COPD) are the first cause of admission to Pulmonary Department in Italy and worldwide. Guidelines recommend treating most patients hospitalized for exacerbations of COPD with antibiotics, even if the role of bacterial infection is often uncertain and the effect of antibiotics poor. The recommendation to use antibiotics is guided by clinical signs and symptoms that have an insufficient diagnostic accuracy, whereas serum biomarkers as procalcitonin (PRO-CT) may guide the selection of COPD patients who need antibiotic treatment. The main aim of the study is to investigate whether antibiotics can be safely stopped after 3 days or continued for 10 days according to a PRO-CT-guided algorithm in patients hospitalized for exacerbations of COPD for whom guidelines recommend 3-10 days antibiotic treatment based on presence of increased dyspnoea, sputum and purulence. The study is designed to assess the non inferiority of the PRO-CT guided plan as compared to the standard guideline recommended plan. The PRO-CT guided withholding of antibiotics is viewed as an experimental intervention associated with less antibiotic-associated complications, eg antibiotic resistance and drug-related side-effect and lower costs. The proposed study is a prospective, randomised controlled, single-blinded intervention trial comparing the standard with a PRO-CT guided antibiotic treatment plan. Patients will be recruited from the Pulmonary Department of 18 University or City Hospitals in Italy, starting October 2006 and continuing until December 2010. Results expected by end of 2011. The 100 patients randomised to the standard non PRO-CT guided antibiotic treatment plan will continue antibiotics for 10 days, whereas the 100 patients randomised to the PRO-CT guided antibiotic treatment plan will continue for 10 days or stop antibiotics on day 3 depending on PRO-CT levels measured at admission, day 1 and day 2. Serum PRO-CT will be measured in a central laboratory. Patients will be examined at admission, discharge, 10 days, 1, 3 and 6 months. A telephone interview will be obtained at 2, 4 and 5 months. The primary outcome of the study will be the rate of exacerbations. Secondary outcomes will be hospital readmission, admission to ICU, change in FEV1, duration of hospitalization, and death. The sample size was estimated according to the primary outcome of the study.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Patients will be recruited from the Pulmonary Department of 18 University or City Hospitals in Italy, starting October 2006 and continuing until December 2010. The 100 patients randomised to the standard non PRO-CT guided antibiotic treatment plan will continue antibiotics for 10 days, whereas the 100 patients randomised to the PRO-CT-guided antibiotic treatment plan will continue for 10 days or stop antibiotics on day 3 depending on PRO-CT levels measured at admission, day 1 and day 2. Serum PRO-CT will be measured in a central laboratory. Patients will be examined at admission (visit 1), discharge and/or at 10 days (visit 4), 1 (visit 5), 3 (visit 6) and 6 months (visit 7). A telephone interview will be obtained at 2, 4 and 5 months. The primary outcome of the study will be the rate of exacerbations. Secondary outcomes will be hospital readmission, admission to ICU, change in FEV1, duration of hospitalization, and death. The sample size was estimated according to the primary outcome of the study.

研究の種類

観察的

入学 (実際)

183

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イタリア
      • Modena、イタリア、41100
        • University of Modena and Reggio Emilia

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～95年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Patients with diagnosis of COPD according to GOLD guidelines

説明

Inclusion Criteria:

  • Male and female patients who give written informed consent
  • Age: adults >18 years old
  • COPD diagnosis according to GOLD guidelines: FEV1/FVC <70% with FEV1<80% of predicted. If a COPD diagnosis is not evident from previous spirometric exams of the patient, a new spirometry will be obtained within 3 days of admission and a diagnosis of COPD will be made if all of the following conditions are true: 1) FEV1/FVC <70% with FEV1 <80% of predicted; 2) history of cigarette smoking; 3) exclusion of bronchial asthma diagnosis. At the end of the study (i.e. at 6 months) a new spirometric exam will be obtained from these patients to confirm the new diagnosis of COPD made at admission.

  • Diagnosis of COPD exacerbation:

    • defined as acute-onset dyspnoea and/or cough associated with increased purulent sputum production (ANTHONISEN criteria)
    • requiring, according to guidelines (GOLD 2005), treatment with antibiotic
    • requiring hospitalization

Exclusion Criteria:

  • Female subjects: pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (e.g. contraceptive methods other than oral contraceptives, IUD, tubal ligation)

    • Diagnosis of bronchial asthma
    • Coexisting medical conditions: unstable concomitant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic, muscle-skeletal, neoplastic, respiratory or other clinically significant disease (patients with stable and well controlled hypertension or diabetes may be included in the study)
    • Clinical significant laboratory abnormalities indicating unstable concomitant disease
    • Patients in whom survival for at least 1 year is unlikely
    • Inability to give informed consent

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

コホートと介入

グループ/コホート
介入・治療
PRO-CT group: Experimental
COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.
他の：PRO-CT values
  • continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection
  • continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability
  • stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability
  • stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection.
他の名前：
  • Amoxicilline + Clavulanate OR Quinolones
Standard group: No intervention
COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
To Evaluate the Rate of Severe Exacerbations in COPD, Comparing COPD Patients Previously Treated According to the PRO-CT Protocol Versus COPD Patients Previously Treated With Standard Antibiotic Therapy.
時間枠：6 months
We prospectively recruited COPD patients hospitalized for severe exacerbation of COPD and followed them after discharge. The primary end point of the study was the number of patients with at least 1 exacerbation at 6 months after the index exacerbation that was the reason for their hospital admission.
6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Cost/Effectiveness of the Use of PRO-CT-guided Decision Making Protocol on Duration of Antibiotic Therapy in COPD Exacerbations.
時間枠：Discharge /10 days-6 months
Discharge /10 days-6 months
To Evaluate if the PRO-CT-guided Decision Making to Shorten Antibiotic Therapy is Less Effective Than the Guideline Recommended Standard Antibiotic Treatment in Preventing Hospitalization.
時間枠：Discharge/10 days-6 months
We evaluate the number of hospital re-admissions for severe COPD exacerbation in COPD patients of the study population, both in the PRO-CT group and in the standard group, in order to assess if shortening antibiotic therapy taking into account the values of PRO-CT is less effective compared to a standard antibiotic treatment.
Discharge/10 days-6 months
To Verify Survival in COPD Patients Comparing to Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.
時間枠：Discharge/10 days-6 months
We evaluate the number of deaths from any cause among COPD patients in the study population, in order to compare survival among patients both in PRO-CT group and in the standard group.
Discharge/10 days-6 months
To Verify Changes in FEV1 Value in COPD Patients Comparing Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.
時間枠：Discharge/10 days-6 months
COPD patients of the study population will undergo spirometry on visit 1, 4, 5, 7 in order to evaluate if there is change in FEV1 among COPD patients, both in the PRO-CT Group and in the standard Group.
Discharge/10 days-6 months
To Verify the Duration of Hospitalization for Severe Exacerbation in COPD Patients Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.
時間枠：Discharge/10 days-6 months
We evaluate the duration in days in case of hospitalization for severe COPD exacerbation in COPD patients in the study population, both in the PRO-CT-guided antibiotic treatment group and in the standard antibiotic treatment group.
Discharge/10 days-6 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Modena and Reggio Emilia

協力者

Agenzia Italiana del Farmaco

捜査官

  • 主任研究者：Leonardo M Fabbri, MD、University of Modena and Reggio Emilia

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2006年10月1日

一次修了 (実際)

2011年7月1日

研究の完了 (実際)

2011年12月1日

試験登録日

最初に提出

2010年4月13日

QC基準を満たした最初の提出物

2010年5月17日

最初の投稿 (見積もり)

2010年5月18日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年12月17日

QC基準を満たした最後の更新が送信されました

2014年12月9日

最終確認日

2014年12月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • FARM58J2XH

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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