Summary

for people ages 18-99 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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.

Official Title

Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae

Details

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.

Keywords

Gonorrhoea Ciprofloxacin-susceptibility Gyrase A Assay Neisseria gonorrhoeae Disease Susceptibility Gonorrhea Ciprofloxacin

Eligibility

You can join if…

Open to people ages 18-99

  • Willing and able to give voluntary written informed consent before any study related procedure is performed.
  • 18 years or older, on the day of enrollment.
  • Untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract, as determined by the gyrA test assay on a specimen collected within 30 days of enrollment.

--Subjects must have gyrA serine 91 genotype detected for N. gonorrhoeae from at least one non-pharyngeal site.

  • Willing to abstain from sexual intercourse or use condoms during any sexual contact until the Test of Cure Visit (Visit 2, Day 5-9) is complete.
  • Women of childbearing potential must have practiced a highly effective method of contraception for the 30-day period before enrollment and agree to continue until follow-up is complete.

--A woman of childbearing potential unless post-menopausal (greater than 2 years) or surgically sterilized (tubal ligation greater than 1 year, bilateral oophorectomy, or hysterectomy).

---Acceptable birth control methods for the purposes of this study may include abstinence from intercourse with a male partner, monogamous relationship with vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, and licensed hormonal methods. A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1 percent per year)when used consistently and correctly.

  • Able to swallow pills.
  • Willing to comply with protocol requirements, including availability for follow-up for the duration of the study.
  • Agree to avoid systemic or intravaginal antibiotics with activity against N.gonorrhoeae from enrollment through Visit 2 (Day 5-9). Topical and intravaginal antifungals are permitted.
  • Agree to avoid magnesium/aluminum antacids, sucralfate, didanosine, or highly buffered drugs, up to 2 hours after receipt of study drug.

You CAN'T join if...

  • Known renal insufficiency from clinical history.
  • Use of systemic or intravaginal antibiotics with potential activity against N.gonorrhoeae within 30 days prior to study drug administration

--Topical and intravaginal antifungals are permitted.

  • Use of systemic corticosteroid drugs or other immunosuppressive therapy within 30 days prior to enrollment.
  • Receipt or planned receipt of an investigational product in a clinical trial within 30 days prior to or 7 days after treatment administration.
  • Pregnant or breastfeeding.
  • Clinical diagnosis of pelvic inflammatory disease or genital ulcer.
  • Confirmed or suspected complicated or systemic gonococcal infection, such as abdominal pain, testicular pain, epididymitis, orchitis, arthritis, or endocarditis.
  • Receipt of magnesium/aluminum antacids, sucralfate, didanosine, or highly buffered drugs, within 6 hours before receipt of study drug.
  • Mutant N. gonorrhoeae gyrA serine 91 genotype from any anatomic site, as determined by the gyrA test assay on a specimen collected within 30 days of enrollment.
  • Known allergy or history of adverse reaction to ciprofloxacin.
  • Known allergy to quinolones.
  • Previous enrollment in this study.
  • Medical condition or other factor that in the judgment of the investigator might affect ability to comply with procedures.

Locations

  • University of California, San Diego - Antiviral Research Center not yet accepting patients
    San Diego California 92103-8208 United States
  • University of California, San Diego Health - Owen Clinic not yet accepting patients
    San Diego California 92103 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
ID
NCT02961751
Study Type
Interventional
Last Updated
January 25, 2018