Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618534
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Azithromycin for Meningococcal Carriage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Azithromycin in Eradicating Nasopharyngeal Carriage of N Meningitidis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effectiveness of azithromycin in the eradication of nasopharyngeal carriage of N meningitidis
Detailed Description:
Azithromycin belongs to the class of antimicrobials known as macrolides They are approved for the treatment of a wide variety of infections including community-acquired respiratory tract infections and sexually transmitted infections caused by different bacteria Their mechanism of action is dependent on bacterial ribosomal binding leading to inhibition of bacterial protein synthesis Azithromycin has a broad spectrum of activity to include Gram-positive and Gram-negative organisms as well as atypical and mycobacterial organisms
A single oral dose of 500mg of azithromycin has been shown to eradicate N meningitidis colonization Historically azithromycin has not been recommended as first-line chemoprophylaxis for close contacts of patients with invasive meningococcal disease IMD since it has not been well studied for this indication A study from 2020 evaluated the activity of azithromycin against 205 invasive N meningitidis isolates and found that 100 were susceptible according to Clinical and Laboratory Standards Institute CLSI breakpoints Moreover with the rise in cases of meningococcal disease caused by ciprofloxacin-resistant strains the Centers for Disease Control and Prevention CDC recently updated their guidance to health department for when to consider other options including azithromycin
Participants identified as carriers of N meningitidis will be asked to take a one-time oral dose of azithromycin 500mg standard dose
A single oral dose of 500mg of azithromycin has been shown to eradicate N meningitidis colonization Historically azithromycin has not been recommended as first-line chemoprophylaxis for close contacts of patients with invasive meningococcal disease IMD since it has not been well studied for this indication A study from 2020 evaluated the activity of azithromycin against 205 invasive N meningitidis isolates and found that 100 were susceptible according to Clinical and Laboratory Standards Institute CLSI breakpoints Moreover with the rise in cases of meningococcal disease caused by ciprofloxacin-resistant strains the Centers for Disease Control and Prevention CDC recently updated their guidance to health department for when to consider other options including azithromycin
Participants identified as carriers of N meningitidis will be asked to take a one-time oral dose of azithromycin 500mg standard dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None