Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrheaoe
Brief Summary: Data from this clinical study will be used to assess if the treatment approach meets CDC criteria for becoming a recommended treatment (cure rate greater than 95 percent with a lower CI:95percent greater than 95 percent) or alternative treatment (cure rate greater than 95 percent with a lower CI95 percent greater than 90 percent) for uncomplicated gonococcal infection. An estimated cure rate of 0.98. A single-arm clinical study design, allowing for a 10 percent subject drop-out rate and 10 percent non-evaluable rate. Screening Visit will include a NG NAAT; the Baseline Visit at Day 1 will include a NG NAAT and culture; Test of Cure Visit at Day 6 will include a NG NAAT and culture. The primary objective of this study is to determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae infections with gyrA serine 91 genotype.