NCT06618534

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,120

participants targeted

Target at P75+ for phase_2

Timeline
1mo left

Started Nov 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Nov 2024May 2026

First Submitted

Initial submission to the registry

September 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 12, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

September 26, 2024

Last Update Submit

November 7, 2025

Conditions

Meningococcal Infections

Outcome Measures

Primary Outcomes (1)

  • 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), Day 21 (2 weeks after azithromycin administration)

Secondary Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (1)

Azithromycin

EXPERIMENTAL

Persons with microbiologic documentation of N. meningitidis carriage will receive a single, standard dose of azithromycin.

Drug: Azithromycin

Interventions

AzithromycinDRUG

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

Azithromycin

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

RECRUITING

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Paulina Rebolledo, MD, MSc

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulina Rebolledo, MD, MSc

CONTACT

404-251-8855preboll@emory.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 1, 2024

Study Start

November 12, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Last Updated

November 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Bacterial genome sequences will be deposited in "Public databases for molecular typing and microbial genome diversity" (PubMLST).

Shared Documents
STUDY PROTOCOL
Time Frame
Individual participant data will be available for sharing following publication of results from this study, with no end date.
Access Criteria
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/

Locations

US(1)