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Completed

NCT Number: NCT06618534

Azithromycin for Meningococcal Carriage

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

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Key information

Conditions

Meningococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Neisseriaceae Infections

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

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

Primary outcomes

  1. Eradication of N. meningitidis carriage

    Time frame: Day 7 (immediately prior to azithromycin administration) and Day 21 (2 weeks after azithromycin administration)

    Eradication of N. meningitidis carriage is defined as positive culture at the second visit (immediately prior to azithromycin administration) and negative culture approximately 2 weeks after antibiotic administration.

Secondary outcomes

  1. Proportion of Participants Culture-Positive

    Time frame: Day 1 (screening visit)

    Carriage prevalence is examined as the proportion of participants who are culture-positive at the initial visit, by serogroup and meningococcal vaccination status.

  2. Minimal Inhibitory Concentrations (MICs) for Ciprofloxacin

    Time frame: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)

    The minimum inhibitory concentrations (MICs) are the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism following overnight incubation. The MICs for ciprofloxacin among meningococcal isolates before and after azithromycin administration will be examined.

  3. Minimal Inhibitory Concentrations (MICs) for Rifampin

    Time frame: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)

    The minimum inhibitory concentrations (MICs) are the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism following overnight incubation. The MICs for rifampin among meningococcal isolates before and after azithromycin administration will be examined.

  4. Minimal Inhibitory Concentrations (MICs) for Ceftriaxone

    Time frame: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)

    The minimum inhibitory concentrations (MICs) are the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism following overnight incubation. The MICs for ceftriaxone among meningococcal isolates before and after azithromycin administration will be examined.

  5. Minimal Inhibitory Concentrations (MICs) for Azithromycin

    Time frame: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)

    The minimum inhibitory concentrations (MICs) are the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism following overnight incubation. The MICs for azithromycin among meningococcal isolates before and after azithromycin administration will be examined.

  6. Risk Factors for Meningococcal Carriage

    Time frame: Day 1 (screening visit)

    Risk factors contributing to meningococcal carriage will be assessed by administering a survey to participants asking about their meningococcal vaccination status, recent antibiotic use, recent respiratory illness, smoke exposure and other social behaviors, with responses given in a "yes" or "no" format.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Georgia Department of Public Health

Registry information

Official study title

Effectiveness of Azithromycin in Eradicating Nasopharyngeal Carriage of N. Meningitidis

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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