Ignite Creation Date:
2024-05-06 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03341273
Status:
TERMINATED
Last Update Posted:
2023-06-28
First Post:
2017-11-09
Brief Title:
Placebo-Controlled Trial of Antibiotic Therapy in Adults With Suspect Lower Respiratory Tract Infection LRTI and a Procalcitonin Level
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Targeted Reduction of Antibiotics Using Procalcitonin in a Multi-center Randomized Double-Blinded Placebo-Controlled Non-Inferiority Study of Azithromycin Treatment in Outpatient Adults With Suspect Lower Respiratory Tract Infection LRTI and a Procalcitonin PCT Level of 025 ngmL TRAP-LRTI
Status:
TERMINATED
Status Verified Date:
2020-03-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to covid
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double-blinded placebo-controlled non-inferiority multicenter clinical trial of azithromycin vs placebo in adults presenting as outpatients with suspect Lower Respiratory Tract Infection LRTI and a Procalcitonin PCT level of 025 ngmL as a strategy for reducing antibiotic prescriptions The study is designed to compare the efficacy of azithromycin versus placebo on Day 5 ie after 4 days of treatment in subjects with suspect LRTI and PCT levels of 025 ngmL at enrollment using a non-inferiority approach The study will recruit potential subjects 18 years of age or older who are suspected to have LRTI The enrollment cap will be 840 participants for the goal of approximately 674 randomized participants who will be randomized 11 to receive oral azithromycin or placebo for five days Randomized subjects will have efficacy measured from the time of the first dose of study drug Day 1 through approximately Day 28 The Primary Objective is to compare the efficacy of azithromycin versus placebo on Day 5 ie after 4 days of treatment in subjects with suspect LRTI and PCT levels of 025 ngmL at enrollment using a non-inferiority approach
Detailed Description:
This is a randomized double-blinded placebo-controlled non-inferiority multicenter clinical trial of azithromycin vs placebo in adults presenting as outpatients with suspect Lower Respiratory Tract Infection LRTI and a Procalcitonin PCT level of 025 ngmL as a strategy for reducing antibiotic prescriptions The study is designed to compare the efficacy of azithromycin versus placebo on Day 5 ie after 4 days of treatment in subjects with suspect LRTI and PCT levels of 025 ngmL at enrollment using a non-inferiority approach The study will recruit potential subjects 18 years of age or older who are suspected to have LRTI The enrollment cap will be 840 participants for the goal of approximately 674 randomized participants who will be randomized 11 to receive oral azithromycin or placebo for five days Randomized subjects will have efficacy measured from the time of the first dose of study drug Day 1 through approximately Day 28 The primary objective is to compare the efficacy of azithromycin versus placebo on Day 5 ie after 4 days of treatment in subjects with suspect LRTI and PCT levels of 025 ngmL at enrollment using a non-inferiority approach The secondary objectives are to compare1 groups receiving azithromycin versus placebo with regard to all antibiotic use by Days 11 and 28 2 groups receiving azithromycin versus placebo with regard to return visits to a physicians office or urgent care by Days 11 and 28 3 groups receiving azithromycin versus placebo with regard to emergency department visits by Days 11 and 28 4 groups receiving azithromycin versus placebo with regard to hospitalization by Days 11 and 28 if not hospitalized at the enrollment and randomization visit 5 groups receiving azithromycin versus placebo with regard to improvement in presenting symptoms by Days 11 and 28 6 the efficacy of azithromycin versus placebo on Day 11 in subjects with suspect LRTI and PCT levels of 025 ngmL at enrollment using a non-inferiority approach 7 the efficacy of azithromycin versus placebo on Day 28 in subjects with suspect LRTI and PCT levels of 025 ngmL at enrollment using a non-inferiority approach 8 the efficacy of azithromycin versus placebo in subjects with suspected LRTI and PCT levels of 025 ngmL at Day 5 using a superiority approach employing the Response Adjusted for Days of Antibiotic Risk RADAR methodology 9 groups receiving azithromycin versus placebo in regard to solicited events by Day 5 10 groups receiving azithromycin versus placebo in regard to hospitalization or visits to an Emergency Department ED outpatient clinic or urgent care center for worsening or persistent LRTI after randomization by Day 5 11 groups receiving azithromycin versus placebo in regard to improvement in vital sign abnormalities or symptoms present at enrollment on Day 5 12 groups receiving azithromycin versus placebo in regard to new vital sign abnormalities or symptoms on Day 5 or deterioration in symptoms relative to the enrollment visit on Day 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
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 |
|---|---|---|---|
| HHSN272201300015I | None | None | None |