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

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ClinicalTrials.gov Identifier: NCT02961751
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE November 9, 2016
First Posted Date  ICMJE November 11, 2016
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE October 19, 2016
Actual Primary Completion Date January 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
The proportion of subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) with microbiological cure [ Time Frame: Day 5 through Day 10 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
The proportion of subjects infected with gyrA serine 91 genotype N. gonorrhoeae with microbiological cure. [ Time Frame: Day 5-9 ]
Change History Complete list of historical versions of study NCT02961751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
  • The proportion of microbiologically cured subjects who had female urogenital tract infection caused by gyrA serine 91 genotype N. gonorrhoeae [ Time Frame: Day 5 through Day 10 ]
  • The proportion of microbiologically cured subjects who had male urogenital tract infection caused by gyrA serine 91 genotype N. gonorrhoeae [ Time Frame: Day 5 through Day 10 ]
  • The proportion of microbiologically cured subjects who had rectum infection caused by gyrA serine 91 genotype N. gonorrhoeae [ Time Frame: Day 5 through Day 10 ]
  • The proportion of microbiologically cured subjects who had throat infection caused by gyrA serine 91 genotype N. gonorrhoeae [ Time Frame: Day 5 through Day 10 ]
  • The proportion of subjects infected with gyrA serine 91 genotype N. gonorrhoeae (identified by gyrA gene polymerase chain reaction (PCR)) who have ciprofloxacin-susceptible N. gonorrhoeae (identified by culture-based antimicrobial susceptibility testing) [ Time Frame: Day 1 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae
Official Title  ICMJE Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Gonococcal Infection
Intervention  ICMJE Drug: Ciprofloxacin
Directly observed treatment with a single dose of ciprofloxacin 500 mg orally with or without food.
Study Arms  ICMJE Ciprofloxacin
One dose of directly-observed ciprofloxacin 500 mg administered orally. N=381
Intervention: Drug: Ciprofloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2019)
211
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2016)
257
Actual Study Completion Date  ICMJE January 4, 2019
Actual Primary Completion Date January 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Willing and able to give voluntary written informed consent before any study related procedure is performed.
  2. 18 years or older, on the day of enrollment.
  3. 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.

  4. Willing to abstain from sexual intercourse or use condoms during any sexual contact until the Test of Cure Visit (Visit 2, Day 5-10) is complete.
  5. Women of childbearing potential must have no vaginal intercourse 14 days before enrollment or use an effective birth control method for 30 days before enrollment and agree to continue through visit 2.

    *A woman is considered 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.

  6. Able to swallow pills.
  7. Willing to comply with protocol requirements, including availability for follow-up for the duration of the study.
  8. Agree to avoid systemic or intravaginal antibiotics with activity against N. gonorrhoeae from enrollment through Visit 2 (Day 5-10). Topical and intravaginal antifungals are permitted.
  9. Agree to avoid magnesium/aluminum antacids, sucralfate, didanosine, or highly buffered drugs, up to 2 hours after receipt of study drug.

Exclusion Criteria:

  1. Known renal insufficiency from clinical history.
  2. 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.

  3. Use of systemic corticosteroid drugs or other immunosuppressive therapy within 30 days prior to enrollment.
  4. Receipt or planned receipt of an investigational product in a clinical trial within 30 days prior to or 7 days after treatment administration.
  5. Pregnant or breastfeeding.
  6. Clinical diagnosis of pelvic inflammatory disease or genital ulcer.
  7. Confirmed or suspected complicated or systemic gonococcal infection, such as abdominal pain, testicular pain, epididymitis, orchitis, arthritis, or endocarditis.
  8. Receipt of magnesium/aluminum antacids, sucralfate, didanosine, or highly buffered drugs, within 6 hours before receipt of study drug.
  9. 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.
  10. Known allergy or history of adverse reaction to ciprofloxacin.
  11. Known allergy to quinolones.
  12. Previous enrollment in this study.
  13. Medical condition or other factor that in the judgment of the investigator might affect ability to comply with procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02961751
Other Study ID Numbers  ICMJE 15-0090
HHSN272201300014I
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date July 27, 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP