Meningococcal InfectionsPhase 2NCT06618534
Azithromycin for Meningococcal Carriage
A Phase 2 study testing Azithromycin in people with Meningococcal Infections, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of azithromycin in the eradication of nasopharyngeal carriage of N. meningitidis Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infections
- What is being tested?
- Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2024to 29 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, 30030
About this study
Official title: Effectiveness of Azithromycin in Eradicating Nasopharyngeal Carriage of N. Meningitidis
The purpose of this study is to determine the effectiveness of azithromycin in the eradication of nasopharyngeal carriage of N. meningitidis
Read the 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).
- Conditions
- Meningococcal Infections
- Being tested
- Azithromycin
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
A standard dose of azithromycin (500 mg) will be delivered by oral route.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Experimental | Persons with microbiologic documentation of N. meningitidis carriage will receive a single, standard dose of azithromycin. Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of N. meningitidis carriage
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.
Measured: Day 7 (immediately prior to azithromycin administration) and Day 21 (2 weeks after azithromycin administration)
Secondary outcomes (6)
Proportion of Participants Culture-Positive
Carriage prevalence is examined as the proportion of participants who are culture-positive at the initial visit, by serogroup and meningococcal vaccination status.
Measured: Day 1 (screening visit)
Minimal Inhibitory Concentrations (MICs) for Ciprofloxacin
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.
Measured: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)
Minimal Inhibitory Concentrations (MICs) for Rifampin
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.
Measured: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)
Minimal Inhibitory Concentrations (MICs) for Ceftriaxone
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.
Measured: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)
Minimal Inhibitory Concentrations (MICs) for Azithromycin
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.
Measured: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)
Risk Factors for Meningococcal Carriage
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.
Measured: Day 1 (screening visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start12 Nov 2024
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal InfectionsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Georgia Department of Public Health
- Responsible party
- Principal investigator, Paulina Rebolledo, Emory University
- Investigators
- Paulina Rebolledo, MD, MSc, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618534
- Sponsor's protocol ID
- STUDY00008433
- Other IDs
- CDC-STUDY00008433, 2025P012505
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Bacterial genome sequences will be deposited in "Public databases for molecular typing and microbial genome diversity" (PubMLST).
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Azithromycin in Eradicating Nasopharyngeal Carriage of N. Meningitidis
- ClinicalTrials.gov ID
- NCT06618534
- Acronym / sponsor ID
- STUDY00008433
- Conditions
- Meningococcal Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Georgia Department of Public Health
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Experimental | Drug: AzithromycinPersons with microbiologic documentation of N. meningitidis carriage will receive a single, standard dose of azithromycin. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinA standard dose of azithromycin (500 mg) will be delivered by oral route. | Drug | Azithromycin |
Primary outcome
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.
6 secondary outcomes
Proportion of Participants Culture-Positive
Time frame: Day 1 (screening visit)
Minimal Inhibitory Concentrations (MICs) for Ciprofloxacin
Time frame: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)
Minimal Inhibitory Concentrations (MICs) for Rifampin
Time frame: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)
Minimal Inhibitory Concentrations (MICs) for Ceftriaxone
Time frame: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)
Minimal Inhibitory Concentrations (MICs) for Azithromycin
Time frame: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)
Risk Factors for Meningococcal Carriage
Time frame: Day 1 (screening visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. Bacterial genome sequences will be deposited in "Public databases for molecular typing and microbial genome diversity" (PubMLST).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulina Rebolledo, MD, MSc principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azithromycin in people with Meningococcal Infections, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication of N. meningitidis carriage (time frame: Day 7 (immediately prior to azithromycin administration) and Day 21 (2 weeks after azithromycin administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.