Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae
Condition: Gonococcal Infection
MeSH terms: Gonorrhea; Disease Susceptibility
Study type: Interventional

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 gyrase A (gyrA)
      serine 91 genotype Neisseria gonorrhoeae (N. gonorrhoeae) as determined by a real-time
      Polymerase Chain Reaction (PCR) assay. The study will enroll approximately 381 subjects to
      obtain an eligibility target of 257 subjects, per protocol, age 18 and older regardless of
      gender identification who are seeking care in Sexually Transmitted Disease (STD) clinics of
      up to eight of the 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 Nucleic Acid Amplification Test (NAAT) conducted at a
      prior visit will be offered enrollment in the study. They will receive one dose of directly
      observed ciprofloxacin 500 milligrams. Subjects not consenting to participate in the study
      will receive treatment per local standard of care. The duration of the study for each subject
      will be approximately 11 through 14 days. 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 description: 
      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 gyrase A (gyrA)
      serine 91 genotype Neisseria gonorrhoeae (N. gonorrhoeae) as determined by a real-time
      Polymerase Chain Reaction (PCR) assay. The study will enroll approximately 381 subjects to
      obtain an eligibility target of 257 subjects, per protocol, age 18 and older regardless of
      gender identification who are seeking care in Sexually Transmitted Disease (STD) clinics of
      up to eight of the 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 Nucleic Acid Amplification Test (NAAT) conducted at a
      prior visit will be offered enrollment in the study. They will receive one dose of directly
      observed ciprofloxacin 500 milligrams. Subjects not consenting to participate in the study
      will receive treatment per local standard of care. The duration of the study for each subject
      will be approximately 11 through 14 days. 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.
    

Intervention name(s): Ciprofloxacin
Intervention type(s): Drug
Intervention description(s): Directly observed treatment with a single dose of ciprofloxacin 500 mg orally with or without food.
Intervention MeSH terms: Ciprofloxacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ciprofloxacin-susceptibility; Efficacy; Gyrase A Assay; Neisseria gonorrhoeae