Clinical Trial: Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrheaoe

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.

Detailed Summary: 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 and 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. Subjects not consenting to participate in the study will receive treatment per local standard of care. 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. The secondary objectives of the study are to 1) investigate the efficacy of ciprofloxacin for treatment of uncomplicated serine 91 gyrA N. gonorrhoeae infection by anatomic site and 2) to determine the sensitivity of the gyrA assay for detection of ciprofloxacin-susceptible N. gonorrhoeae infections.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome: The proportion of subjects infected with gyrA serine 91 genotype N. gonorrhoeae with microbiological cure. [ Time Frame: Day 5-9 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The proportion of subjects infected with gyrA serine 91 genotype N. gonorrhoeae identified by gyrA gene PCR who have ciprofloxacin-susceptible N. gonorrhoeae as identified by culture-based antimicrobial susceptibility testing. [ Time Frame: Day 1 ]
  • The proportion of subjects infected with gyrA serine 91 genotype N. gonorrhoeae with microbiological cure at each male or female urogenital tract) [ Time Frame: Day 5-9 ]
  • The proportion of subjects infected with gyrA serine 91 genotype N. gonorrhoeae with microbiological cure at rectum. [ Time Frame: Day 5-9 ]
  • The proportion of subjects infected with gyrA serine 91 genotype N. gonorrhoeae with microbiological cure at throat. [ Time Frame: Day 5-9 ]


Original Secondary Outcome: Same as current

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: November 9, 2016
Date Started: September 13, 2016
Date Completion: January 15, 2018
Last Updated: May 18, 2017
Last Verified: April 11, 2017