Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368804
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-02-22
Brief Title:
Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis
Sponsor:
Centre Hospitalier Intercommunal Creteil
Organization:
Centre Hospitalier Intercommunal Creteil
Study Overview
Official Title:
Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With Pseudomonas Aeruginosa in Adults With Bronchiectasis a Non-inferiority Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
ANTEIPA
Brief Summary:
Chronic airways infection with Pseudomonas aeruginosa PA is associated with increased frequency of exacerbations deterioration in quality of life and increased mortality in adult patients with bronchiectasis Current guidelines suggest the prescription of an eradication antibiotic treatment for a first episode of PA infection early PA infection Several antibiotic regimens may be proposed ranging from a monotherapy with oral fluoroquinolone FQ to an intravenous cotherapy with the addition of inhaled antibiotics that seems to improve the rate of PA eradication As no study strictly favoured one regimen current practices are heterogeneous and could certainly benefit from stronger evidence with both medical and economic impact
Detailed Description:
According to current knowledge the early combination of an oral FQ to an inhaled antibiotic could be an acceptable alternative to a systemic cotherapy Indeed such regimen allows avoiding IV drugs use facilitating ambulatory management and influencing patients quality of life and costs and may achieve similar PA-eradication rate
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 |
|---|---|---|---|
| 2022-A01575-38 | OTHER | ID-RCB | None |