Experimental Human Infection With Neisseria Gonorrhoeae

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

April 23, 2017

Primary Completion Date

November 25, 2019

Study Completion Date

November 25, 2019

Conditions
Gonococcal Infection
Interventions
DRUG

Cefixime

Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.

DRUG

Ceftriaxone

Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.

DRUG

Ciprofloxacin

Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the subject has a positie test of cure 1 week post initial antibiotic treatment

BIOLOGICAL

Neisseria gonorrhoeae strain FA1090 A26

0.4 mL of a suspension containing 10\^5 - 10\^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.

BIOLOGICAL

Neisseria gonorrhoeae strain FA7537

0.4 mL of a suspension containing 10\^5 - 10\^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter

Trial Locations (1)

27514-4220

University of North Carolina Health Care - Infectious Diseases, Chapel Hill

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03840811 - Experimental Human Infection With Neisseria Gonorrhoeae | Biotech Hunter | Biotech Hunter