DMID 15-0090: Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria gonorrhoeae

This study is a multi-center, single-arm, open-label clinical study to assess the efficacy of one dose of ciprofloxacin given orally in subjects infected with untreated gyrA serine 91 genotype N. gonorrhoeae as determined by a real-time PCR assay. The study will enroll approximately 381 subjects to obtain a per protocol eligible target of 257 subjects age 18 years or older regardless of gender identification who are seeking care in STD clinics at participating sites in the United States. Subjects who have untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract identified by a positive culture or NAAT conducted at a prior visit will be offered enrollment in the study.

It has been recently demonstrated that N. gonorrhoeae-deoxyribonucleic acid (DNA) mutations can be detected using modern molecular techniques and real-time polymerase chain reaction (PCR) assays can be used to detect reproducible, clinically significant resistance. A protocol for the detection of alterations in the gyrase A gene (gyrA), the target of ciprofloxacin anti-gonococcal activity, has been validated.
Primary Objective
To determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae infections with gyrA serine 91 genotype
Secondary Objectives
1) To investigate the efficacy of ciprofloxacin for treatment of uncomplicated serine 91 gyrA N. gonorrhoeae infection by anatomic site
2) To determine the sensitivity of the gyrA assay for detection of ciprofloxacin-susceptible N. gonorrhoeae infections
Exploratory Objectives
1) To characterize N. gonorrhoeae isolates and non-gyrA gene-dependent mechanisms of ciprofloxacin resistance post-treatment of uncomplicated N. gonorrhoeae infection by anatomic site using traditional and molecular methods like genotyping and sequencing
2) To investigate the efficacy of ciprofloxacin for treatment of uncomplicated serine 91 gyrA N. gonorrhoeae infections by demographic and clinical characteristics

Status: 
Enrolling