Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05903352
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-06-06
Brief Title:
Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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:
CAT-CAP
Brief Summary:
The primary objective of the study is to evaluate if the efficacy of an experimental strategy on antibiotic treatment duration based on stopping treatment when stability criteria are reached after at least 48 h of treatment is non-inferior to the efficacy of standard antibiotic duration in CAP patients treated in the hospital setting
As the secondary objectives the study aims
To study if the efficacy of our experimental strategy on antibiotic treatment duration compared to standard of care in CAP patients treated in the hospital setting is non-inferior in terms of
Persistence of cure at Day 30 of antibiotic treatment
All-cause mortality rate on Day 30 of antibiotic treatment
Patients evolution of pneumonia symptoms and quality of life via 2 scores CAP score CAP Sym at Day 0 of treatment retrospectively at stability Day S at Day 7 at Day 15 and at Day 30 of antibiotic treatment
To compare between the 2 study arms at Day 30 of antibiotic treatment
The duration of antibiotic treatment
The length of hospital stay
The frequency and severity of adverse events during the 30 days after the start of treatment
To explore the impact of reduced antibiotic treatment duration for CAP on the oropharyngeal resistome
As the secondary objectives the study aims
To study if the efficacy of our experimental strategy on antibiotic treatment duration compared to standard of care in CAP patients treated in the hospital setting is non-inferior in terms of
Persistence of cure at Day 30 of antibiotic treatment
All-cause mortality rate on Day 30 of antibiotic treatment
Patients evolution of pneumonia symptoms and quality of life via 2 scores CAP score CAP Sym at Day 0 of treatment retrospectively at stability Day S at Day 7 at Day 15 and at Day 30 of antibiotic treatment
To compare between the 2 study arms at Day 30 of antibiotic treatment
The duration of antibiotic treatment
The length of hospital stay
The frequency and severity of adverse events during the 30 days after the start of treatment
To explore the impact of reduced antibiotic treatment duration for CAP on the oropharyngeal resistome
Detailed Description:
Recent studies have suggested that community-acquired pneumonia CAP can be successfully treated with short-course antibiotic regimen when clinical improvement is rapidly obtained Even if clinical response is obtained in 3 days in the majority of cases it can vary widely among patients suggesting one duration does not fit all An individualised duration of therapy depending on the patients response could help to ensure bacterial eradication while avoiding unnecessary antibiotic exposure and thus reduce antibiotic resistance At present this strategy has never been tested
This is a phase III pragmatic non-inferiority randomised 11 national multicentre trial Population of study participants will be patients admitted to hospital with suspected CAP and in need for antibiotics
There is no need to establish a DSMB for this trial The antibiotic treatments prescribed during this study are treatments used in current practice with well-known adverse drug reactions Furthermore a 3-day treatment duration has already been studied in 2 previous randomized clinical trials showing its safety for hospitalized CAP
Statistical analysis
Statistical inference for non-inferiority will be based on the confidence intervals CI of the difference in Day 15 cure proportions proportion in reference arm - proportion in experimental arm accounting for randomisation stratification factors centre and delay from Day 0 to Day S 3 days or 3 days
The inferiority hypothesis will be rejected and non-inferiority will be claimed if the upper bound of the 95CI of the difference is 10
Secondary efficacy endpoints evaluating the evolution of symptoms will be analysed using either a GMM or a GEE for categorical and continuous variables respectively
Other quantitative variables will be compared using the Student t-test or a non-parametric test if the distribution remains skewed following transformation while categorical variables will be analysed using either the Chi-squared or the Fisher-exact tests
All statistical tests will be performed with a level of significance of 5 except the primary endpoint which be analysed with a 25 level of significance
This is a phase III pragmatic non-inferiority randomised 11 national multicentre trial Population of study participants will be patients admitted to hospital with suspected CAP and in need for antibiotics
There is no need to establish a DSMB for this trial The antibiotic treatments prescribed during this study are treatments used in current practice with well-known adverse drug reactions Furthermore a 3-day treatment duration has already been studied in 2 previous randomized clinical trials showing its safety for hospitalized CAP
Statistical analysis
Statistical inference for non-inferiority will be based on the confidence intervals CI of the difference in Day 15 cure proportions proportion in reference arm - proportion in experimental arm accounting for randomisation stratification factors centre and delay from Day 0 to Day S 3 days or 3 days
The inferiority hypothesis will be rejected and non-inferiority will be claimed if the upper bound of the 95CI of the difference is 10
Secondary efficacy endpoints evaluating the evolution of symptoms will be analysed using either a GMM or a GEE for categorical and continuous variables respectively
Other quantitative variables will be compared using the Student t-test or a non-parametric test if the distribution remains skewed following transformation while categorical variables will be analysed using either the Chi-squared or the Fisher-exact tests
All statistical tests will be performed with a level of significance of 5 except the primary endpoint which be analysed with a 25 level of significance
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504208-27-00 | OTHER | EU CT number | None |