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

This study has been completed.
Sponsor:
Collaborator:
Agenzia Italiana del Farmaco
Information provided by (Responsible Party):
Leonardo M. Fabbri, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01125098
First received: April 13, 2010
Last updated: December 9, 2014
Last verified: December 2014
Results First Received: December 9, 2014  
Study Type: Observational
Condition: Chronic Obstructive Pulmonary Disease
Intervention: Other: PRO-CT values

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PRO-CT Group: Experimental

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.
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.

Participant Flow:   Overall Study
    PRO-CT Group: Experimental     Standard Group: No Intervention  
STARTED     91     90  
COMPLETED     88     90  
NOT COMPLETED     3     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PRO-CT Group: Experimental

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.
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.
Total Total of all reporting groups

Baseline Measures
    PRO-CT Group: Experimental     Standard Group: No Intervention     Total  
Number of Participants  
[units: participants]
  91     90     181  
Age [1]
[units: years]
Median (Inter-Quartile Range)
  73.5  
  (68.5 to 78)  
  72.5  
  (65 to 78)  
  73  
  (66.5 to 78)  
Gender  
[units: participants]
     
Female     11     13     24  
Male     80     77     157  
Region of Enrollment  
[units: participants]
     
Italy     91     90     181  
[1] Age, median (IQR)



  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   11/2014   Safety Issue:   Yes

4.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   11/2014   Safety Issue:   Yes

5.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   11/2014   Safety Issue:   Yes

6.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   11/2014   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Leonardo Fabbri
Organization: Department of Oncology Haematology and Respiratory Diseases
phone: +39 059422 ext 4227
e-mail: leonardo.fabbri@unimore.it


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Leonardo M. Fabbri, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01125098     History of Changes
Other Study ID Numbers: FARM58J2XH
Study First Received: April 13, 2010
Results First Received: December 9, 2014
Last Updated: December 9, 2014
Health Authority: Italy: Ethics Committee