Phase 1 N=27 Basic Science

Experimental Human Infection With Neisseria Gonorrhoeae

Gonococcal Infection

Bottom Line

View on ClinicalTrials.gov: NCT03840811 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: 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 — 15.11 ratio — p=0.230

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Cefixime (Drug); Ceftriaxone (Drug); Ciprofloxacin (Drug); Neisseria gonorrhoeae strain FA1090 A26 (Biological); Neisseria gonorrhoeae strain FA7537 (Biological)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	15.11	0.230
PRIMARY 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	0.86; 1.00	0.54
PRIMARY Proportion of Participants That Become Infected as Defined by a Positive Urine or Urethral Swab Culture for Infections Initiated With Mixed Inocula	1.00	—
SECONDARY Median Time From Inoculation to Treatment Among Infected Participants by Day 6, by Strain, in Non-competitive Infections	3.0; 3.0	—
SECONDARY Proportion of Participants With Occurrence of Bacteriuria in Non-competitive Infections, by Strain	0.86; 1.00	—
SECONDARY Proportion of Participants With Occurrence of Signs and Symptoms of Urethritis Attributable to Gonococcal Infection in Non-competitive Infections, by Strain	1.00; 1.00	—
SECONDARY Proportion of Participants With Occurrence of Urethritis in Non-competitive Infections	1.00; 1.00	—

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.

Eligibility Criteria

Inclusion Criteria

Healthy man > / = 18 and 5 years ago
Denies history of drug abuse
Denies history of genitourinary surgery

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 Human Immunodeficiency Virus (HIV) infection
Psychiatric disorders that, in the opinion of the physician, would interfere with the integrity of the data or volunteer safety
Unstable depression (defined as receiving either 1.75 mg/dL and deemed clinically significant by the study physician
Serum ALT level 105 U/L and deemed clinically significant by the study physician
WBC count 15.0 x 10^9/L and deemed clinically significant by the study physician
Absolute neutrophil count (ANC) 7.5 x 10^9/L and deemed clinically significant by the study physician Exception: For African Americans, ANC values as low as 1.3 x 10^9/L will be allowed (25)
Hemoglobin level 1+ or RBC count > 10/hpf

Medications not permitted with cefixime or ceftriaxone:

Warfarin
Probenecid
Aspirin
Diuretics such as furosemide
Aminoglycoside antibiotics
Chloramphenicol

Medications not permitted with ciprofloxacin:

Tizanidine
Theophylline
Warfarin
Glyburide
Cyclosporine
Probenecid
Phenytoin
Methotrexate
Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc
Caffeine-containing medications
Sucralfate or didanosine chewable or buffered tablets

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03840811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.