Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gent for Pharyngeal Gonorrhea (GC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03632109
Recruitment Status : Terminated (Efficacy)
First Posted : August 15, 2018
Results First Posted : August 10, 2020
Last Update Posted : August 10, 2020
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Lindley Barbee, University of Washington

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pharyngeal Gonococcal Infection
Intervention Drug: gentamicin 360mg IM
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm
Hide Arm/Group Description Pharyngeal Gonorrhea
Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Single Arm
Hide Arm/Group Description Pharyngeal Gonorrhea
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
29.3
(21 to 44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
0
   0.0%
Male
13
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
  23.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   7.7%
White
3
  23.1%
More than one race
0
   0.0%
Unknown or Not Reported
6
  46.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
 100.0%
Weight (kg)  
Mean (Full Range)
Unit of measure:  Kg
Number Analyzed 13 participants
86.4
(53 to 133)
Height (in)  
Mean (Full Range)
Unit of measure:  In
Number Analyzed 13 participants
70.9
(68 to 76)
BMI (kg/m2)  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 13 participants
26.6
(17.9 to 43.4)
Baseline Creatinine  
Mean (Full Range)
Unit of measure:  mg/dL
Number Analyzed 13 participants
0.86
(0.74 to 1.05)
PrEP Status (Taking HIV PrEP)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
8
  61.5%
Number of oral sex partners in the last 2 months  
Mean (Full Range)
Unit of measure:  Reported sex partners
Number Analyzed 13 participants
4.2
(0 to 10)
1.Primary Outcome
Title 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
Hide Description Negative Pharyngeal Culture
Time Frame 4-7 days (+/- 1 day) after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Positive culture at enrollment and returned for test of cure, or negative culture at enrollment but positive culture at test of cure
Arm/Group Title Pharyngeal Gonorrhea
Hide Arm/Group Description:
Evaluable Population
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
2
  20.0%
2.Secondary Outcome
Title Renal Safety
Hide Description Measured by a percent change in serum creatinine from baseline to test of cure (4-7 days following treatment)
Time Frame 4-7 days (+/- 1 day) after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 13
Mean (95% Confidence Interval)
Unit of Measure: percent change
5.2
(0.20 to 10.1)
3.Secondary Outcome
Title Tolerability of the Injection Gentamicin 360mg IM x 1
Hide Description Participant reported pain scale, with 1 being little to no pain, and 10 being the worst pain ever.
Time Frame 4-7 days (+/- 1 day) after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
Pharyngeal gonorrhea
Overall Number of Participants Analyzed 13
Mean (Full Range)
Unit of Measure: score on a scale
2
(1 to 7)
4.Secondary Outcome
Title Peak Gentamicin Levels
Hide Description serum gentamicin concentration
Time Frame at 30, 45, or 60 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants had missing gentamicin levels
Arm/Group Title Single Arm
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 11
Mean (Full Range)
Unit of Measure: microgram/mL
21.2
(15 to 30)
5.Secondary Outcome
Title Gentamicin Minimal Inhibitory Concentration (MIC)
Hide Description laboratory defined MIC of infecting strain of N. gonorrhoeae at enrollment visit determined by agar dilution
Time Frame baseline/enrollment visit
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants were culture negative at enrollment
Arm/Group Title Single Arm
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 11
Mean (Full Range)
Unit of Measure: microgram/mL
6.9
(4 to 8)
6.Other Pre-specified Outcome
Title Exploratory Study: Look for Evidence of Induced Resistance
Hide Description Among treatment failures, compare pre-treatment and post-treatment minimal inhibitory concentrations (MIC)
Time Frame 4-7 days (+/- 1 day) after treatment
Outcome Measure Data Not Reported
Time Frame Adverse events were collected at the test of cure visit 4-7 days following dosing.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm
Hide Arm/Group Description

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

All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   0/13 (0.00%) 
Hide Serious Adverse Events
Single Arm
Affected / at Risk (%)
Total   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Arm
Affected / at Risk (%)
Total   7/13 (53.85%) 
Ear and labyrinth disorders   
Hearing Changes   1/13 (7.69%) 
Gastrointestinal disorders   
Vomiting   1/13 (7.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Fatigue   2/13 (15.38%) 
Nervous system disorders   
Headache   6/13 (46.15%) 
Renal and urinary disorders   
Urine Changes   1/13 (7.69%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lindley Barbee, Principal Investigator
Organization: University of Washington
Phone: 206.744.2595
EMail: lbarbee@u.washington.edu
Layout table for additonal information
Responsible Party: Lindley Barbee, University of Washington
ClinicalTrials.gov Identifier: NCT03632109    
Other Study ID Numbers: STUDY00003878
K23AI113185 ( U.S. NIH Grant/Contract )
First Submitted: July 3, 2018
First Posted: August 15, 2018
Results First Submitted: July 6, 2020
Results First Posted: August 10, 2020
Last Update Posted: August 10, 2020