Clinical trial NCT06618534: Azithromycin for Meningococcal Carriage
Official title: Effectiveness of Azithromycin in Eradicating Nasopharyngeal Carriage of N. Meningitidis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Meningococcal Infections
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Georgia Department of Public Health
First posted: 2024-10-01
Enrollment: 1120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Eradication of N. meningitidis carriage
timeFrame: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)
Secondary outcomes:
measure: Proportion of Participants Culture-Positive
timeFrame: Day 1 (screening visit)
measure: Minimal Inhibitory Concentrations (MICs) for Ciprofloxacin
timeFrame: Day 1 (screening visit)
measure: Minimal Inhibitory Concentrations (MICs) for Rifampin
timeFrame: Day 1 (screening visit)
measure: Minimal Inhibitory Concentrations (MICs) for Ceftriaxone
timeFrame: Day 1 (screening visit)
measure: Minimal Inhibitory Concentrations (MICs) for Azithromycin
timeFrame: Day 1 (screening visit)
measure: Risk Factors for Meningococcal Carriage
timeFrame: Day 1 (screening visit)
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Hope Clinic of the Emory Vaccine Center
state: Georgia
Study officials:
affiliation: Emory University
name: Paulina Rebolledo, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: