Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDC-STUDY00008433 | Other Identifier | Centers for Disease Control and Prevention | |
| 2025P012505 | Other Identifier | Emory IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Georgia Department of Public Health | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effectiveness of azithromycin in the eradication of nasopharyngeal carriage of N. meningitidis
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Experimental | Persons with microbiologic documentation of N. meningitidis carriage will receive a single, standard dose of azithromycin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | A standard dose of azithromycin (500 mg) will be delivered by oral route. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7 (immediately prior to azithromycin administration) and Day 21 (2 weeks after azithromycin administration) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 (screening visit) |
| Minimal Inhibitory Concentrations (MICs) for Ciprofloxacin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paulina Rebolledo, MD, MSc | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Clinic of the Emory Vaccine Center | Decatur | Georgia | 30030 | United States |
Bacterial genome sequences will be deposited in "Public databases for molecular typing and microbial genome diversity" (PubMLST).
Individual participant data will be available for sharing following publication of results from this study, with no end date.
Data will be made available for sharing with anyone who wishes to access the data, for any purpose. Data will be accessed via https://pubmlst.org/
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 2, 2025 | Jun 2, 2026 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| 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. | 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. | 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. | 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. | Day 1 (screening visit) |
| D007239 | Infections |
| Organic Chemicals |