Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04135183
Status:
UNKNOWN
Last Update Posted:
2019-10-22
First Post:
2019-10-17
Brief Title:
Assessing Effectiveness of Community Acquired Pneumonia Treatment by Continuous Pneumonia Severity Score
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Assessing Effectiveness of Community Acquired Pneumonia Treatment by Continuous Pneumonia Severity Score a Prospective Observational Study and Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Community acquired pneumonia CAP is a common respiratory infection and is the main cause of ICU admission and death in adults Because of most patients were treated empirically against suspected causative microorganism it is important to assess the effectiveness of treatment after 3 days of anti-infective therapy However the criteria for treatment failure is lack of a clear-cut and validated definition from the CAP guidelines
Pneumonia severity scores is a wide-used severity rating system for treatment selection and outcome prediction for CAP So far the pneumonia severity scores only used once before the treatment started Considering the pneumonia severity scores could reflect the severity of pneumonia it is reasonable to assume that the change of pneumonia severity scores could reflect the patients condition and the effectiveness of the treatment This trail will be designed to validate the feasibility of assessing effectiveness of CAP treatment by using continuous pneumonia severity score
Pneumonia severity scores is a wide-used severity rating system for treatment selection and outcome prediction for CAP So far the pneumonia severity scores only used once before the treatment started Considering the pneumonia severity scores could reflect the severity of pneumonia it is reasonable to assume that the change of pneumonia severity scores could reflect the patients condition and the effectiveness of the treatment This trail will be designed to validate the feasibility of assessing effectiveness of CAP treatment by using continuous pneumonia severity score
Detailed Description:
The applicant has established a CAP patients database and found a new effective pneumonia severity score Expand-CURB According to the retrospective study results applicant found the changes of pneumonia severity score could reflect the patientscondition and was the independent risk factor for 30-day mortality More specifically if the patientsExpand-CURB score was not improved after 3-5 days of initial treatment the odds ratio of 30-day mortality was 5571 and 5249 95CI 1831-15051 P0002 by univariate analysis and multivariate analysis the multivariate was adjusted by the initial severity of pneumonia
In addition the applicant found the changes of serum CRPC reactive protein before and after initial treatment also associated the patientsoutcomes If the serum CRP decreased less than 40 or not lower than 20mgdl after the initial treatment the odds ratio of 30-day mortality will be 3692 and 3806 95CI 1867-7756 P0001 by univariate analysis and multivariate analysis
In conclusion the applicant established three criteria for assessing effectiveness of CAP treatment
1 Effective treatment by PSI the PSI score decreased after 3-5 days the initial treatment
2 Effective treatment by Expand-CURB the Expand-CURB score decreased after 3-5 days the initial treatment
3 Effective treatment by serum CRP the serum CRP decreased more than 40 or lower than 20mgdl after 3-5 days the initial treatment
Furthermore the applicant found combined pneumonia severity scores with CRP could predict the 30-day mortality more efficiently The OR for both CRP and PSI treatment failure was 2377 95CI 1100-5136 P0028 And the OR for both CRP and Expand-CURB treatment failure was 7332 95CI 1563-34385 P0012 Therefore it is reasonable to assume that the change of pneumonia severity scores and CRP could reflect the patientscondition and the effectiveness of the treatment
To validate the feasibility of assessing effectiveness of CAP treatment by using continuous pneumonia severity score and changes of CRP applicant intend to randomly allocate the patients into three arms Comprehensive evaluation group PSI evaluation group and Expand-CURB evaluation group Patients who did not agree to participate the randomized controlled study will be asked whether they agree to provide their clinical data for prospective observational studies
The primary outcomes will be 30-day mortality and ICU admission The second outcome is length of hospital stay
In addition the applicant found the changes of serum CRPC reactive protein before and after initial treatment also associated the patientsoutcomes If the serum CRP decreased less than 40 or not lower than 20mgdl after the initial treatment the odds ratio of 30-day mortality will be 3692 and 3806 95CI 1867-7756 P0001 by univariate analysis and multivariate analysis
In conclusion the applicant established three criteria for assessing effectiveness of CAP treatment
1 Effective treatment by PSI the PSI score decreased after 3-5 days the initial treatment
2 Effective treatment by Expand-CURB the Expand-CURB score decreased after 3-5 days the initial treatment
3 Effective treatment by serum CRP the serum CRP decreased more than 40 or lower than 20mgdl after 3-5 days the initial treatment
Furthermore the applicant found combined pneumonia severity scores with CRP could predict the 30-day mortality more efficiently The OR for both CRP and PSI treatment failure was 2377 95CI 1100-5136 P0028 And the OR for both CRP and Expand-CURB treatment failure was 7332 95CI 1563-34385 P0012 Therefore it is reasonable to assume that the change of pneumonia severity scores and CRP could reflect the patientscondition and the effectiveness of the treatment
To validate the feasibility of assessing effectiveness of CAP treatment by using continuous pneumonia severity score and changes of CRP applicant intend to randomly allocate the patients into three arms Comprehensive evaluation group PSI evaluation group and Expand-CURB evaluation group Patients who did not agree to participate the randomized controlled study will be asked whether they agree to provide their clinical data for prospective observational studies
The primary outcomes will be 30-day mortality and ICU admission The second outcome is length of hospital stay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None