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

NCT02961751 | Completed Results

• 1 other identifier: 15-0090
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 9

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.

Conditions

Gonococcal Infection

Keywords

Ciprofloxacin-susceptibility; Efficacy; Gyrase A Assay; Neisseria gonorrhoeae

Outcome Measures

Primary Outcomes (1)

• The Percentage of Subjects Infected With Gyrase A (gyrA) Serine 91 Genotype of Neisseria Gonorrhoeae (N. Gonorrhoeae) With Microbiological Cure

  Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline.

  Day 5 through Day 10

Secondary Outcomes (7)

• The Percentage of Microbiologically Cured Subjects Who Had Urogenital Tract Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae

  Day 5 through Day 10

• The Percentage of Microbiologically Cured Subjects Who Had Rectal Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae

  Day 5 through Day 10

• The Percentage of Microbiologically Cured Subjects Who Had Throat Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae

  Day 5 through Day 10

• The Number of Subjects With Urethral Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae

  Day 1

• The Number of Subjects With Cervical Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae

  Day 1

Study Arms (1)

Ciprofloxacin

OTHER

One dose of directly-observed ciprofloxacin 500 mg administered orally. N=381

Drug: Ciprofloxacin

Interventions

Ciprofloxacin DRUG

Directly observed treatment with a single dose of ciprofloxacin 500 mg orally with or without food.

Ciprofloxacin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give voluntary written informed consent before any study related procedure is performed.
• 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 5-10) is complete.
• 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.
• 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 5-10). 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 may not qualify 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (9)

AIDS Healthcare Foundation Wellness Center - Hollywood

Los Angeles, California, 90027, United States

Location

Los Angeles Lesbian Gay Bisexual/Transgender Center

Los Angeles, California, 90028-6213, United States

Location

University of California, San Diego - Antiviral Research Center

San Diego, California, 92103-8208, United States

Location

University of California, San Diego Health - Owen Clinic

San Diego, California, 92103, United States

Location

San Francisco Department of Public Health - San Francisco City Clinic

San Francisco, California, 94103-4030, United States

Location

Whitman-Walker Health

Washington D.C., District of Columbia, 20005, United States

Location

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70119, United States

Location

University of Mississippi - Infectious Diseases

Jackson, Mississippi, 39202, United States

Location

Philadelphia Department of Public Health - Health Center 1

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (1)

• Klausner JD, Bristow CC, Soge OO, Shahkolahi A, Waymer T, Bolan RK, Philip SS, Asbel LE, Taylor SN, Mena LA, Goldstein DA, Powell JA, Wierzbicki MR, Morris SR. Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study. Clin Infect Dis. 2021 Jul 15;73(2):298-303. doi: 10.1093/cid/ciaa596.

  PMID: 32766725 DERIVED

MeSH Terms

Conditions

Gonorrhea

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jeffrey D. Klausner, MD, MPH
• Organization: University of California, Los Angeles

jdklausner@mednet.ucla.edu

310-267-0409

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 11, 2016
• Study Start: October 19, 2016
• Primary Completion: January 4, 2019
• Study Completion: January 4, 2019
• Last Updated: August 25, 2020
• Results First Posted: January 29, 2020

Record last verified: 2019-12-04

Locations

US (9)