Azithromycin for Meningococcal Carriage

Emory University

Status and phase

Enrolling

Phase 2

Conditions

Meningococcal Infections

Treatments

Drug: Azithromycin

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT06618534

CDC-STUDY00008433 (Other Identifier)

STUDY00008433

2025P012505 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of azithromycin in the eradication of nasopharyngeal carriage of N. meningitidis

Full 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).

Enrollment

1,120 estimated patients

Sex

All

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Able to provide their own informed consent and understand study procedures
Undergraduate and graduate students attending Emory University affiliated campuses who reside in university affiliated housing (for undergraduate/graduate) or in off-campus housing (undergraduates).

Exclusion criteria

University faculty and staff
Currently pregnant or breast feeding
History of immediate or moderate-to-severe allergic reactions to azithromycin
Individuals who have taken systemic antibiotics for any reason in the 30 days prior to enrollment
Individuals with any symptoms of acute illness at the time of screening