Experimental Human Infection With Neisseria Gonorrhoeae (NCT03840811) | Clinical Trial Compass
CompletedPhase 1
Experimental Human Infection With Neisseria Gonorrhoeae
United States27 participantsStarted 2017-04-23
Plain-language summary
This is a Phase 1, interventional, non-randomized, experimental infection model study with healthy adult males adults (N=32) between the ages of 18-36 at study enrollment. The study is designed to test the requirements of predicted N. gonorrhoeae virulence determinants for gonococcal infection in the male urethra. The duration for all participants will be about 3 weeks. Study duration will be approximately about 18 months for implementation and enrollment. The primary objectives of the present study are to: (1) compare infectivity of different isogenic mutants with wild-type (WT) N. gonorrhoeae in noncompetitive infections and to (2) assess relative fitness of the mutant in competitive infections initiated by inocula containing equivalent numbers of both WT and mutant strains for mutants with WT infectivity.
Who can participate
Age range18 Years ā 36 Years
SexMALE
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
ā. Healthy man \> / = 18 and \< 36 years old
ā. Able and willing to be located easily by providing street address and telephone number (land line and/or cell phone number)
ā. Willingness to provide written informed consent
ā. Able and willing to attend all study visits including 6-day stay in the Clinical 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
ā. Able and willing to abstain from all sexual activity until completion of the study and the follow-up test for gonorrhea is negative
ā. Acceptable medical history by screening evaluation
ā. No clinically significant abnormalities on physical exam
ā. Urinalysis: leukocyte esterase, and White Blood Cell (WBC) values within normal limits (WNL)
Exclusion criteria
ā. Student or employee under the direct supervision of any of the study investigators
What they're measuring
1
The Competitive Index of the Mutant Compared to Wild Type Proportion of Organisms With the Predicted Competitive Advantage Recovered From Urine and/or Urethral Swab Specimens From Infected Participants
Timeframe: Baseline and the day of treatment, any day between Day 2 and Day 6
2
Proportion of Participants That Become Infected as Defined by a Positive Urine or Urethral Swab Culture Among Infections Initiated With Individual N. Gonorrhoeae Strains in Non-competitive Infections
Timeframe: day of infection, any day between Day 2 and Day 6
3
Proportion of Participants That Become Infected as Defined by a Positive Urine or Urethral Swab Culture for Infections Initiated With Mixed Inocula
Timeframe: day of infection, any day between Day 2 and Day 6
Trial details
NCT IDNCT03840811
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
ā. Any known immunodeficiencies including complement deficiency, antibody deficiency, chronic granulomatous disease or Human Immunodeficiency Virus (HIV) infection
ā. Psychiatric disorders that, in the opinion of the physician, would interfere with the integrity of the data or volunteer safety
ā. 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
ā. Heart murmur or heart disease
ā. Anatomic abnormality of the urinary tract
ā. Any antibiotic treatment in the past 30 days, or azithromycin in the past 60 days
ā. Self-reported chemotherapy within the past year