Ignite Creation Date:
2024-05-06 @ 1:56 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04166110
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-23
First Post:
2019-09-30
Brief Title:
Antibiotic Therapy In Respiratory Tract Infections
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
A Controlled Randomized Open Label Multicenter Non-inferiority Trial Evaluating an Individualized Antibiotic Duration Treatment Based on Patient Clinical Response Evaluated Through Connected Devices for Community Acquired Pneumonia in the Community Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
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:
AIR
Brief Summary:
Primary aim to demonstrate that stopping antibiotic treatment in patients diagnosed with acute community acquired pneumonia CAP based on clinical response has a non-inferior efficacy 15 days after start of treatment compared to a conventional predetermined duration left to the physicians judgement in adults treated in the community setting
Secondary aims To compare the 2 study arms on
1 Clinical success at late follow up Day 30
2 Duration of antibiotic treatment
3 Frequency and severity of adverse events
4 Patients pneumonia symptoms and quality of life
Secondary aims To compare the 2 study arms on
1 Clinical success at late follow up Day 30
2 Duration of antibiotic treatment
3 Frequency and severity of adverse events
4 Patients pneumonia symptoms and quality of life
Detailed Description:
Recent studies have suggested that CAP can be successfully treated by 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 widely vary among patients suggesting that one duration does not fit all An individualized 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 pragmatic open label non-inferiority randomized multicenter trial with two parallel arms comparing antibiotic treatment duration left to the physicians judgement usually 7 to 14 days versus interruption of treatment based on the patients clinical response defined by reaching stability criteria body temperature 378C heart rate 100min systolic blood pressure 90mmHg oxygen saturation 90 for 24h after a minimum of 2 days treatment
Recruitment and follow-up Outpatients consulting in a private multiprofessional health center diagnosed as having CAP and in need for antibiotics will be assessed for eligibility Following information and signing consent eligible patients will be included in the study They will receive the prescription antibiotic type and duration determined by the physician preferably chosen according to the French guidelines and a collection of connected devices to monitor their vital signs 2 times a day morning and evening Preselected patients will be randomized as soon as they meet the two following criteria i they have presented the stability criteria for 24h 3 consecutive vital signs recordings ii they have started the antibiotic treatment at least 72 hours before with a 80 compliance and with at least 1 intake in the last 24 hours Each patient will then receive a telephone call from the coordinating team or a permanent medical platform at nights during weekends or public holidays in order to proceed to the randomization and ensure that everything is well understood by the patient as well as the security and compliance with the strategy
A follow-up visit with the investigator will be performed at day 15 after the start of antibiotic treatment
The final evaluation will be performed 30 days following the start of antibiotic treatment by a telephone call from the coordinating team
Number of subjects necessary 310 patients
This is a pragmatic open label non-inferiority randomized multicenter trial with two parallel arms comparing antibiotic treatment duration left to the physicians judgement usually 7 to 14 days versus interruption of treatment based on the patients clinical response defined by reaching stability criteria body temperature 378C heart rate 100min systolic blood pressure 90mmHg oxygen saturation 90 for 24h after a minimum of 2 days treatment
Recruitment and follow-up Outpatients consulting in a private multiprofessional health center diagnosed as having CAP and in need for antibiotics will be assessed for eligibility Following information and signing consent eligible patients will be included in the study They will receive the prescription antibiotic type and duration determined by the physician preferably chosen according to the French guidelines and a collection of connected devices to monitor their vital signs 2 times a day morning and evening Preselected patients will be randomized as soon as they meet the two following criteria i they have presented the stability criteria for 24h 3 consecutive vital signs recordings ii they have started the antibiotic treatment at least 72 hours before with a 80 compliance and with at least 1 intake in the last 24 hours Each patient will then receive a telephone call from the coordinating team or a permanent medical platform at nights during weekends or public holidays in order to proceed to the randomization and ensure that everything is well understood by the patient as well as the security and compliance with the strategy
A follow-up visit with the investigator will be performed at day 15 after the start of antibiotic treatment
The final evaluation will be performed 30 days following the start of antibiotic treatment by a telephone call from the coordinating team
Number of subjects necessary 310 patients
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 |
|---|---|---|---|
| 2019-001873-10 | EUDRACT_NUMBER | None | None |