Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial) (NCT04870138) | Clinical Trial Compass
CompletedPhase 1
Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)
United States16 participantsStarted 2013-03-10
Plain-language summary
This is a Phase 1, interventional, non-randomized, experimental infection model study in healthy adult males (N=up to 25) between the ages of 18-35 at study enrollment. The study is designed to test the requirements of predicted N. gonorrhoeae virulence determinants for gonococcal infection in the male urethra through infection with engineered mutants of N. gonorrhoeae. We predict that mutations abolishing expression of N. gonorrhoeae virulence determinants will eliminate or significantly reduce gonococcal infectivity or the ability to induce inflammation in an infected individual, thus identifying potential vaccine candidates. Study duration will be 1 year, and the duration for all participants will be about 3 weeks. The primary objective of the study is to compare the ability of different engineered mutants of Neisseria gonorrhoeae to cause a clinical infection (signs or symptoms of urethritis such as discomfort during urination, urethral discharge, etc.) in the male urethra.
Who can participate
Age range
18 Years – 35 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy man between the ages of 18 and 35 years.
. Able and willing to be located easily by providing street address and telephone number (land line and/or cell phone number).
. Willingness to provide written informed consent.
. Able and willing to attend all study visits including 6-day stay in the Clinical and Translational Research Center (CTRC) during the trial (with ability to leave the unit during the day) and follow-up visit during the week after treatment.
. Able and willing to abstain from masturbation during the 6-day stay in the CTRC.
. Able and willing to abstain from all sexual activity during the course of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Proportion of Participants That Become Infected With Individual N. Gonorrhoeae Strains in Non-competitive Infections
Timeframe: Day of infection, any day between Day 1 and Day 5
2
The Proportion of Participants That Become Infected With Mixed Inoculum
Timeframe: Day of infection, any day between Day 1 and Day 5
3
The Proportion of Wild Type (WT) Organisms Recovered From Urine and Urethral Swab Specimens From Individual Subjects Infected With Mixed Inoculum
Timeframe: Baseline (Day 0) and the day of infection (any day between Day 1 and Day 5)
Trial details
NCT IDNCT04870138
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Acceptable medical history by screening evaluation.
. Standard physical exam within normal limits (WNL).
Exclusion criteria
. Student or employee under the direct supervision of any of the study investigators.
. Any known immunodeficiencies including complement deficiency, antibody deficiency, chronic granulomatous disease or HIV infection.
. Psychiatric disorders that would interfere with the integrity of the data or volunteer safety.
. Unstable depression (defined as receiving either \< 3 months of the same medication (and dose) or a decompensating event during the previous 3 months) or depression that, in the opinion of the investigator, will compromise the subject's ability to comply with protocol requirements.
. Heart murmur or heart disease.
. Anatomic abnormality of the urinary tract.
. Any antibiotic treatment in the past 30 days, or azithromycin in the past 60 days.