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

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ClinicalTrials.gov Identifier: NCT01125098
Recruitment Status : Completed
First Posted : May 18, 2010
Results First Posted : December 17, 2014
Last Update Posted : December 17, 2014
Sponsor:
Collaborator:
Agenzia Italiana del Farmaco
Information provided by (Responsible Party):
Leonardo M. Fabbri, University of Modena and Reggio Emilia

Study Type Observational
Condition Chronic Obstructive Pulmonary Disease
Intervention Other: PRO-CT values
Enrollment 183
Recruitment Details The recruitment process involved18 university/city hospital pulmonary departments. Patients selected were subjects hospitalized because of severe exacerbation of COPD (increased dyspnea, sputum volume, and sputum purulence according to Anthonisen criteria and/or respiratory failure) requiring antibiotic treatment.
Pre-assignment Details  
Arm/Group Title PRO-CT Group: Experimental Standard Group: No Intervention
Hide Arm/Group Description

COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.

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.
COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
Period Title: Overall Study
Started 91 90
Completed 88 90
Not Completed 3 0
Arm/Group Title PRO-CT Group: Experimental Standard Group: No Intervention Total
Hide Arm/Group Description

COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.

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.
COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations. Total of all reporting groups
Overall Number of Baseline Participants 91 90 181
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 91 participants 90 participants 181 participants
73.5
(68.5 to 78)
72.5
(65 to 78)
73
(66.5 to 78)
[1]
Measure Description: Age, median (IQR)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 90 participants 181 participants
Female
11
  12.1%
13
  14.4%
24
  13.3%
Male
80
  87.9%
77
  85.6%
157
  86.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 91 participants 90 participants 181 participants
91 90 181
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRO-CT Group: Experimental Standard Group: No Intervention
Hide Arm/Group Description:

COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.

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.
COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
Overall Number of Participants Analyzed 91 90
Measure Type: Number
Unit of Measure: participants
28 25
2.Secondary Outcome
Title Cost/Effectiveness of the Use of PRO-CT-guided Decision Making Protocol on Duration of Antibiotic Therapy in COPD Exacerbations.
Hide Description [Not Specified]
Time Frame Discharge /10 days-6 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Discharge/10 days-6 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title To Verify Survival in COPD Patients Comparing to Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.
Hide Description 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.
Time Frame Discharge/10 days-6 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Discharge/10 days-6 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Discharge/10 days-6 months
Outcome Measure Data Not Reported
Time Frame 6 months after the index exacerbation
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PRO-CT Group: Experimental Standard Group: No Intervention
Hide Arm/Group Description

COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.

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.
COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
All-Cause Mortality
PRO-CT Group: Experimental Standard Group: No Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PRO-CT Group: Experimental Standard Group: No Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/91 (0.00%)   0/90 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PRO-CT Group: Experimental Standard Group: No Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/91 (0.00%)   0/90 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Leonardo Fabbri
Organization: Department of Oncology Haematology and Respiratory Diseases
Phone: +39 059422 ext 4227
EMail: leonardo.fabbri@unimore.it
Layout table for additonal information
Responsible Party: Leonardo M. Fabbri, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01125098     History of Changes
Other Study ID Numbers: FARM58J2XH
First Submitted: April 13, 2010
First Posted: May 18, 2010
Results First Submitted: December 9, 2014
Results First Posted: December 17, 2014
Last Update Posted: December 17, 2014