Trial Outcomes & Findings for Gent for Pharyngeal Gonorrhea (GC) (NCT NCT03632109)

NCT ID: NCT03632109

Last Updated: 2020-08-10

Results Overview

Negative Pharyngeal Culture

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

13 participants

Primary outcome timeframe

4-7 days (+/- 1 day) after treatment

Results posted on

2020-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Pharyngeal Gonorrhea
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gent for Pharyngeal Gonorrhea (GC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=13 Participants Pharyngeal Gonorrhea
Age, Continuous	29.3 years n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants
Region of Enrollment United States	13 Participants n=93 Participants
Weight (kg)	86.4 kg n=93 Participants
Height (in)	70.9 in n=93 Participants
BMI (kg/m2)	26.6 kg/m^2 n=93 Participants
Baseline Creatinine	0.86 mg/dL n=93 Participants
PrEP Status (Taking HIV PrEP)	8 Participants n=93 Participants
Number of oral sex partners in the last 2 months	4.2 reported sex partners n=93 Participants

PRIMARY outcome

Timeframe: 4-7 days (+/- 1 day) after treatment

Population: Positive culture at enrollment and returned for test of cure, or negative culture at enrollment but positive culture at test of cure

Negative Pharyngeal Culture

Outcome measures

Outcome measures
Measure	Pharyngeal Gonorrhea n=10 Participants Evaluable Population
Cure Rate Defined as the Percentage of Persons With Pharyngeal Gonorrhea Treated With Gentamicin 360mg IM Who Have a Negative Culture 4-7 Days Following Treatment	2 Participants

SECONDARY outcome

Timeframe: 4-7 days (+/- 1 day) after treatment

Measured by a percent change in serum creatinine from baseline to test of cure (4-7 days following treatment)

Outcome measures

Outcome measures
Measure	Pharyngeal Gonorrhea n=13 Participants Evaluable Population
Renal Safety	5.2 percent change Interval 0.2 to 10.1

SECONDARY outcome

Timeframe: 4-7 days (+/- 1 day) after treatment

Participant reported pain scale, with 1 being little to no pain, and 10 being the worst pain ever.

Outcome measures

Outcome measures
Measure	Pharyngeal Gonorrhea n=13 Participants Evaluable Population
Tolerability of the Injection Gentamicin 360mg IM x 1	2 score on a scale Interval 1.0 to 7.0

SECONDARY outcome

Timeframe: at 30, 45, or 60 minutes post dose

Population: 2 participants had missing gentamicin levels

serum gentamicin concentration

Outcome measures

Outcome measures
Measure	Pharyngeal Gonorrhea n=11 Participants Evaluable Population
Peak Gentamicin Levels	21.2 microgram/mL Interval 15.0 to 30.0

SECONDARY outcome

Timeframe: baseline/enrollment visit

Population: 2 participants were culture negative at enrollment

laboratory defined MIC of infecting strain of N. gonorrhoeae at enrollment visit determined by agar dilution

Outcome measures

Outcome measures
Measure	Pharyngeal Gonorrhea n=11 Participants Evaluable Population
Gentamicin Minimal Inhibitory Concentration (MIC)	6.9 microgram/mL Interval 4.0 to 8.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 4-7 days (+/- 1 day) after treatment

Among treatment failures, compare pre-treatment and post-treatment minimal inhibitory concentrations (MIC)

Outcome measures

Outcome data not reported

Adverse Events

Single Arm

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single Arm n=13 participants at risk Men who have sex with men (MSM) with pharyngeal gonorrhea will be treated with 360mg intramuscular gentamicin x 1. gentamicin 360mg IM: 360mg IM of gentamicin
Nervous system disorders Headache	46.2% 6/13 • Adverse events were collected at the test of cure visit 4-7 days following dosing.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fatigue	15.4% 2/13 • Adverse events were collected at the test of cure visit 4-7 days following dosing.
Ear and labyrinth disorders Hearing Changes	7.7% 1/13 • Adverse events were collected at the test of cure visit 4-7 days following dosing.
Renal and urinary disorders Urine Changes	7.7% 1/13 • Adverse events were collected at the test of cure visit 4-7 days following dosing.
Gastrointestinal disorders Vomiting	7.7% 1/13 • Adverse events were collected at the test of cure visit 4-7 days following dosing.

Additional Information

Dr. Lindley Barbee, Principal Investigator

University of Washington

Phone: 206.744.2595

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place