Comparison of a Serum PRO-CT Guided Treatment and the Recommended Antibiotic Treatment for COPD
|ClinicalTrials.gov Identifier: NCT01125098|
Recruitment Status : Completed
First Posted : May 18, 2010
Results First Posted : December 17, 2014
Last Update Posted : December 17, 2014
|Condition or disease||Intervention/treatment|
|Chronic Obstructive Pulmonary Disease||Other: PRO-CT values|
|Study Type :||Observational|
|Actual Enrollment :||183 participants|
|Official Title:||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|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||December 2011|
PRO-CT group: Experimental
COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.
Other: PRO-CT values
Other Name: 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.
- 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. [ Time Frame: 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.
- Cost/Effectiveness of the Use of PRO-CT-guided Decision Making Protocol on Duration of Antibiotic Therapy in COPD Exacerbations. [ Time Frame: 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. [ Time Frame: 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.
- To Verify Survival in COPD Patients Comparing to Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy. [ Time Frame: 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.
- 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. [ Time Frame: 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.
- 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. [ Time Frame: 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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125098
|University of Modena and Reggio Emilia|
|Modena, Italy, 41100|
|Principal Investigator:||Leonardo M Fabbri, MD||University of Modena and Reggio Emilia|