Effectiveness of Azithromycin in Eradicating Nasopharyngeal Carriage of N. Meningitidis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 764
- Locations
- 1
- Primary Endpoint
- Eradication of N. meningitidis carriage
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Azithromycin
Persons with microbiologic documentation of N. meningitidis carriage will receive a single, standard dose of azithromycin.
Intervention: Azithromycin (Drug)
Outcomes
Primary Outcomes
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
- Proportion of Participants Culture-Positive(Day 1 (screening visit))
- Risk Factors for Meningococcal Carriage(Day 1 (screening visit))
- Proportion of Participants Culture-Positive(Day 1 (screening visit))
- Minimal Inhibitory Concentrations (MICs) for Ciprofloxacin(Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration))
- Minimal Inhibitory Concentrations (MICs) for Rifampin(Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration))
- Minimal Inhibitory Concentrations (MICs) for Ceftriaxone(Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration))
- Minimal Inhibitory Concentrations (MICs) for Azithromycin(Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration))
- Risk Factors for Meningococcal Carriage(Day 1 (screening visit))
Investigators
Paulina Rebolledo
Associate Professor
Emory University