Trial Outcomes & Findings for Aztreonam for Pharyngeal Gonorrhea (NCT NCT03867734)

NCT ID: NCT03867734

Last Updated: 2022-01-18

Results Overview

Negative Test of Cure (i.e. Pharyngeal Gonorrhea Culture) after Treatment

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 32 participants
• Primary outcome timeframe: 4-7 days following treatment
• Results posted on: 2022-01-18

Participant Flow

Participant milestones

Measure	2g Aztreonam Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea Aztreonam: 2g IM Aztreonam
Overall Study STARTED	32
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	2g Aztreonam Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea Aztreonam: 2g IM Aztreonam
Overall Study Lost to Follow-up	2

Baseline Characteristics

Aztreonam for Pharyngeal Gonorrhea

Baseline characteristics by cohort

Measure	2g Aztreonam n=32 Participants Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea Aztreonam: 2g IM Aztreonam
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32 years STANDARD_DEVIATION 21 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants
HIV co-infection	3 Participants n=5 Participants
Sex partner by gender Male	27 partners n=5 Participants
Sex partner by gender Female	0 partners n=5 Participants
Sex partner by gender Trans/nonbinary	4 partners n=5 Participants
Number of oral sex partners in past 2 months (median range)	4 partners n=5 Participants

PRIMARY outcome

Timeframe: 4-7 days following treatment

Population: Subjects with pharyngeal culture positive for gonorrhea at enrollment

Negative Test of Cure (i.e. Pharyngeal Gonorrhea Culture) after Treatment

Outcome measures

Measure	Pharyngeal Gonorrhea -- Evaluable Population n=6 Participants Subjects who were Pharyngeal Gonorrhea Culture Positive at Enrollment and Received 2g Aztreonam intramuscularly (IM) and Returned for Test of Cure (TOC)	Efficacy of 2g Aztreonam for Rectal Gonorrhea Subjects with culture-positive gonorrhea of the rectum, treated with 2g Aztreonam and returned for TOC
Treatment Efficacy of Pharyngeal Gonorrhea as Defined as the Proportion of Study Participants With Positive Pharyngeal Gonorrhea Culture at of Enrollment Whose Test of Cure Pharyngeal Culture is Negative	2 Participants	—

SECONDARY outcome

Timeframe: Test of Cure 4-7 days following treatment

Number of individuals with a negative N. gonorrhoeae culture at an anogenital site at test of cure among those who were N. gonorrhoeae culture positive at the respective anatomic site at the enrollment visit.

Outcome measures

Measure	Pharyngeal Gonorrhea -- Evaluable Population n=9 Participants Subjects who were Pharyngeal Gonorrhea Culture Positive at Enrollment and Received 2g Aztreonam intramuscularly (IM) and Returned for Test of Cure (TOC)	Efficacy of 2g Aztreonam for Rectal Gonorrhea n=4 Participants Subjects with culture-positive gonorrhea of the rectum, treated with 2g Aztreonam and returned for TOC
Efficacy of 2 g Aztreonam for N. Gonorrhoeae at Anogenital Sites	9 Participants	3 Participants

SECONDARY outcome

Timeframe: Immediately following injection

Subjects' self-report of injection related pain on a scale from 0 - 10 where 0 is no pain and 10 is the worst pain ever.

Outcome measures

Measure	Pharyngeal Gonorrhea -- Evaluable Population n=32 Participants Subjects who were Pharyngeal Gonorrhea Culture Positive at Enrollment and Received 2g Aztreonam intramuscularly (IM) and Returned for Test of Cure (TOC)	Efficacy of 2g Aztreonam for Rectal Gonorrhea Subjects with culture-positive gonorrhea of the rectum, treated with 2g Aztreonam and returned for TOC
Tolerability of 2g Aztreonam IM	2 score on a scale Interval 1.0 to 3.0	—

SECONDARY outcome

Timeframe: assessed immediately following injection and 4-7 days after injection

Population: Of the 30 participants who returned for Test of Cure Visit, 6 reported having a possible side effects between treatment and Test of Cure (4-7 days post injection)

Subject's report of perceived side effects related to study drug based on responses to standard side effect questionnaire.

Outcome measures

Measure	Pharyngeal Gonorrhea -- Evaluable Population n=30 Participants Subjects who were Pharyngeal Gonorrhea Culture Positive at Enrollment and Received 2g Aztreonam intramuscularly (IM) and Returned for Test of Cure (TOC)	Efficacy of 2g Aztreonam for Rectal Gonorrhea Subjects with culture-positive gonorrhea of the rectum, treated with 2g Aztreonam and returned for TOC
Side Effects of 2g Aztreonam IM reported having a HEADACHE	6 Participants	—
Side Effects of 2g Aztreonam IM reported having NAUSEA	1 Participants	—

Adverse Events

2g Aztreonam

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	2g Aztreonam n=32 participants at risk Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea Aztreonam: 2g IM Aztreonam
Nervous system disorders Headache	18.8% 6/32 • Thirty minutes after injections and then over the following 4 - 6 days or until Test of Cure Visit. We observed participants for 30 minutes following injection of aztreonam for Type 1 allergic reaction (i.e. IgE mediated-anaphylaxis reactions). A study clinician evaluated participants 4-7 days following aztreonam injection and asked about interim side effects. Aztreonam is usually a very well tolerated. Documented side effects (including, neutropenia, eosinophilia, thrombocytopenia, elevated liver function tests, skin rash, diarrhea, nausea, and vomiting) occur in \<2% of cases.
Gastrointestinal disorders Nausea	3.1% 1/32 • Thirty minutes after injections and then over the following 4 - 6 days or until Test of Cure Visit. We observed participants for 30 minutes following injection of aztreonam for Type 1 allergic reaction (i.e. IgE mediated-anaphylaxis reactions). A study clinician evaluated participants 4-7 days following aztreonam injection and asked about interim side effects. Aztreonam is usually a very well tolerated. Documented side effects (including, neutropenia, eosinophilia, thrombocytopenia, elevated liver function tests, skin rash, diarrhea, nausea, and vomiting) occur in \<2% of cases.

Additional Information

Lindley A. Barbee, MD, MPH

University of Washington

Phone: 206-744-2595

Email: lbarbee@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place