Trial Outcomes & Findings for Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae (NCT NCT02961751)

Last Updated: 2020-08-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

211 participants

Primary outcome timeframe

Day 5 through Day 10

Results posted on

2020-08-25

Participant Flow

Sites/clinics recruited subjects from their existing patient population, patients that were sent by referral from other clinics, and walk-ins. 232 volunteers were screened to enroll 211 subjects between 13SEP2016 and 31DEC2018.

Participant milestones

Participant milestones
Measure	Ciprofloxacin One dose of directly-observed ciprofloxacin 500 mg administered orally.
Overall Study STARTED	211
Overall Study COMPLETED	196
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Ciprofloxacin One dose of directly-observed ciprofloxacin 500 mg administered orally.
Overall Study Lost to Follow-up	11
Overall Study Physician Decision	2
Overall Study Not Eligible at Enrollment	1
Overall Study Protocol Violation	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ciprofloxacin n=211 Participants One dose of directly-observed ciprofloxacin 500 mg administered orally
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	211 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.9 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	190 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	148 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	70 Participants n=5 Participants
Race (NIH/OMB) White	103 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants
Region of Enrollment United States	211 participants n=5 Participants
Baseline Rectal/Urogenital Wild-Type N. gonorrhoeae infection	109 Participants n=5 Participants
Baseline Urogenital Wild-Type N. gonorrhoeae infection	34 Participants n=5 Participants
Baseline Rectal Wild-Type N. gonorrhoeae infection	79 Participants n=5 Participants
Baseline Pharyngeal Wild-Type N. gonorrhoeae infection	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 5 through Day 10

Population: The per protocol population was limited to subjects meeting all inclusion criteria and no exclusion criteria and who were positive for rectal/urogenital wild type N. gonorrhoeae at baseline.

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=99 Participants One dose of directly-observed ciprofloxacin 500 mg administered orally
The Percentage of Subjects Infected With Gyrase A (gyrA) Serine 91 Genotype of Neisseria Gonorrhoeae (N. Gonorrhoeae) With Microbiological Cure	100 percentage of subjects Interval 97.0 to 100.0

SECONDARY outcome

Timeframe: Day 5 through Day 10

Population: The per protocol population was limited to subjects meeting all inclusion criteria and no exclusion criteria and who were positive for urogenital wild type N. gonorrhoeae at baseline.

Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the urogenital tract 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

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=30 Participants One dose of directly-observed ciprofloxacin 500 mg administered orally
The Percentage of Microbiologically Cured Subjects Who Had Urogenital Tract Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae	100 percentage of subjects Interval 90.5 to 100.0

SECONDARY outcome

Timeframe: Day 5 through Day 10

Population: The per protocol population was limited to subjects meeting all inclusion criteria and no exclusion criteria and who were positive for rectal wild type N. gonorrhoeae at baseline.

Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the rectum 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

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=73 Participants One dose of directly-observed ciprofloxacin 500 mg administered orally
The Percentage of Microbiologically Cured Subjects Who Had Rectal Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae	100 percentage of subjects Interval 96.0 to 100.0

SECONDARY outcome

Timeframe: Day 5 through Day 10

Population: The per protocol population was limited to subjects meeting all inclusion criteria and no exclusion criteria and who were positive for wild type N. gonorrhoeae of the throat at baseline.

Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the throat 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

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=14 Participants One dose of directly-observed ciprofloxacin 500 mg administered orally
The Percentage of Microbiologically Cured Subjects Who Had Throat Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae	100 percentage of subjects Interval 80.7 to 100.0

SECONDARY outcome

Timeframe: Day 1

Population: Analysis population was intention-to-treat.

Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each urethral sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was \< 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=22 Participants One dose of directly-observed ciprofloxacin 500 mg administered orally
The Number of Subjects With Urethral Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae	22 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Analysis population was intention-to-treat.

Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each cervical sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was \< 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=7 Participants One dose of directly-observed ciprofloxacin 500 mg administered orally
The Number of Subjects With Cervical Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae	7 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Analysis population was intention-to-treat.

Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each rectal sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was \< 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=60 Participants One dose of directly-observed ciprofloxacin 500 mg administered orally
The Number of Subjects With Rectal Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae	60 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Analysis population was intention-to-treat.

Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each pharyngeal sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was \< 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=13 Participants One dose of directly-observed ciprofloxacin 500 mg administered orally
The Number of Subjects With Pharyngeal Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae	13 Participants

Adverse Events

Ciprofloxacin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey D. Klausner, MD, MPH

University of California, Los Angeles

Phone: 310-267-0409

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60