Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

March 10, 2013

Primary Completion Date

April 28, 2015

Study Completion Date

April 28, 2015

Conditions
Gonococcal Infection
Interventions
DRUG

Azithromycin

Alternative antibiotic treatment failure therapy: Azithromycin 2 g orally in a single dose after treatment failure with both cephalosporin and quinolone antibiotics.

DRUG

Ceftriaxone

Mandatory antibiotic treatment failure therapy: Ceftriaxone 250 mg intramuscular 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 on patient request, at the onset of symptoms or on the 5th study day after inoculation.

BIOLOGICAL

Neisseria gonorrhoeae strain FA1090 A26

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

BIOLOGICAL

Neisseria gonorrhoeae strain FA7527

0.4 mL of a suspension containing 10\^5 - 10\^6 CFU of isogenic LptA mutant 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

NCT04870138 - Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial) | Biotech Hunter | Biotech Hunter