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Azithromycin for Meningococcal Carriage

NCT ID: NCT06618534

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

1120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-12

Study Completion Date

2026-05-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Meningococcal Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azithromycin

Persons with microbiologic documentation of N. meningitidis carriage will receive a single, standard dose of azithromycin.

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

A standard dose of azithromycin (500 mg) will be delivered by oral route.

Interventions

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Azithromycin

A standard dose of azithromycin (500 mg) will be delivered by oral route.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Georgia Department of Public Health

UNKNOWN

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Paulina Rebolledo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paulina Rebolledo, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paulina Rebolledo, MD, MSc

Role: CONTACT

Phone: 404-251-8855

Email: [email protected]

Other Identifiers

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CDC-STUDY00008433

Identifier Type: OTHER

Identifier Source: secondary_id

2025P012505

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00008433

Identifier Type: -

Identifier Source: org_study_id