Ignite Creation Date:
2024-05-06 @ 1:39 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04089787
Status:
RECRUITING
Last Update Posted:
2023-03-08
First Post:
2019-09-11
Brief Title:
Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia
Sponsor:
Thomas Benfield
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
Shortened Antibiotic Treatment in Community-Acquired Pneumonia A Nationwide Danish Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
CAP5
Brief Summary:
CAP5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia CAP in hospitalized adult patients based on clinical stability criteria
Three to five days after initiation of antimicrobial therapy for CAP participants are randomized 11 to parallel treatment arms 5 days intervention or minimum 7 days control of antibiotic treatment The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile for at least 48 hours The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician
The primary outcome is 90-day survival which will be tested with a non-inferiority margin of 6
Three to five days after initiation of antimicrobial therapy for CAP participants are randomized 11 to parallel treatment arms 5 days intervention or minimum 7 days control of antibiotic treatment The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile for at least 48 hours The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician
The primary outcome is 90-day survival which will be tested with a non-inferiority margin of 6
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-000404-15 | EUDRACT_NUMBER | None | None |