Trial Outcomes & Findings for Comparison of a Serum PRO-CT Guided Treatment and the Recommended Antibiotic Treatment for COPD (NCT NCT01125098)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

183 participants

Primary outcome timeframe

6 months

Results posted on

2014-12-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	91	90
Overall Study COMPLETED	88	90
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRO-CT Group: Experimental n=91 Participants 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 n=90 Participants 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 n=181 Participants Total of all reporting groups
Age, Continuous	73.5 years n=5 Participants	72.5 years n=7 Participants	73 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	77 Participants n=7 Participants	157 Participants n=5 Participants
Region of Enrollment Italy	91 participants n=5 Participants	90 participants n=7 Participants	181 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PRO-CT Group: Experimental n=91 Participants 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 n=90 Participants 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.	28 participants Interval -7.23 to 15.31	25 participants Interval -7.23 to 15.31

SECONDARY outcome

Timeframe: Discharge /10 days-6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

PRO-CT Group: Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Group: No Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leonardo Fabbri

Department of Oncology Haematology and Respiratory Diseases

Phone: +39 059422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place