Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae
Status:
Completed
Trial end date:
2019-01-04
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)