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- Klinische proef NCT01125098
Comparison of a Serum PRO-CT Guided Treatment and the Recommended Antibiotic Treatment for COPD
9 december 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
183
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Modena, Italië, 41100
- University of Modena and Reggio Emilia
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 95 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Patients with diagnosis of COPD according to GOLD guidelines
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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PRO-CT group: Experimental
COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.
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Andere namen:
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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.
Tijdsspanne: 6 months
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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.
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6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Cost/Effectiveness of the Use of PRO-CT-guided Decision Making Protocol on Duration of Antibiotic Therapy in COPD Exacerbations.
Tijdsspanne: Discharge /10 days-6 months
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Discharge /10 days-6 months
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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.
Tijdsspanne: Discharge/10 days-6 months
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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.
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Discharge/10 days-6 months
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To Verify Survival in COPD Patients Comparing to Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.
Tijdsspanne: Discharge/10 days-6 months
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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.
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Discharge/10 days-6 months
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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.
Tijdsspanne: Discharge/10 days-6 months
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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.
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Discharge/10 days-6 months
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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.
Tijdsspanne: Discharge/10 days-6 months
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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.
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Discharge/10 days-6 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Leonardo M Fabbri, MD, University of Modena and Reggio Emilia
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2006
Primaire voltooiing (Werkelijk)
1 juli 2011
Studie voltooiing (Werkelijk)
1 december 2011
Studieregistratiedata
Eerst ingediend
13 april 2010
Eerst ingediend dat voldeed aan de QC-criteria
17 mei 2010
Eerst geplaatst (Schatting)
18 mei 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
17 december 2014
Laatste update ingediend die voldeed aan QC-criteria
9 december 2014
Laatst geverifieerd
1 december 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Longziekten
- Longziekten, obstructief
- Longziekte, chronisch obstructief
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Enzymremmers
- Antibacteriële middelen
- beta-Lactamaseremmers
- Amoxicilline
- Clavulaanzuur
- Combinatie amoxicilline-kaliumclavulanaat
Andere studie-ID-nummers
- FARM58J2XH
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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