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Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea

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ClinicalTrials.gov Identifier: NCT02257918
Recruitment Status : Completed
First Posted : October 7, 2014
Results First Posted : February 8, 2017
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition Gonorrhoea
Interventions Drug: AZD0914
Drug: Ceftriaxone
Enrollment 180
Recruitment Details Untreated participants with signs and symptoms of urethral or cervical gonorrhea, or confirmed urethral or cervical gonorrhea as defined by positive culture, NAAT test, or Gram-stain or any type of sexual contact in the past 14 days with an infected individual were enrolled between 25NOV2014 and 02DEC2015.
Pre-assignment Details  
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description Participants receive single oral dose of 2000 mg of AZD0914/ETX0914. Participants receive single oral dose of 3000 mg of AZD0914/ETX0914. Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Period Title: Overall Study
Started 72 67 41
Test of Cure Visit 72 67 40
Completed 68 66 39
Not Completed 4 1 2
Reason Not Completed
Lost to Follow-up             4             1             0
Withdrawal by Subject             0             0             1
Pregnancy             0             0             1
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg Total
Hide Arm/Group Description Participants receive single oral dose of 2000 mg of AZD0914/ETX0914. Participants receive single oral dose of 3000 mg of AZD0914/ETX0914. Participants receive single intramuscular dose of 500 mg of ceftriaxone. Total of all reporting groups
Overall Number of Baseline Participants 72 67 41 180
Hide Baseline Analysis Population Description
All participants enrolled and randomized are included in the baseline analysis population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 67 participants 41 participants 180 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
72
 100.0%
67
 100.0%
41
 100.0%
180
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 67 participants 41 participants 180 participants
29.2  (8.9) 28.3  (7.6) 29.1  (8.2) 28.8  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 67 participants 41 participants 180 participants
Female
2
   2.8%
8
  11.9%
3
   7.3%
13
   7.2%
Male
70
  97.2%
59
  88.1%
38
  92.7%
167
  92.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 67 participants 41 participants 180 participants
Hispanic or Latino
5
   6.9%
4
   6.0%
4
   9.8%
13
   7.2%
Not Hispanic or Latino
67
  93.1%
63
  94.0%
37
  90.2%
167
  92.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 67 participants 41 participants 180 participants
American Indian or Alaska Native
1
   1.4%
0
   0.0%
0
   0.0%
1
   0.6%
Asian
1
   1.4%
2
   3.0%
0
   0.0%
3
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   2.4%
1
   0.6%
Black or African American
44
  61.1%
40
  59.7%
23
  56.1%
107
  59.4%
White
24
  33.3%
19
  28.4%
15
  36.6%
58
  32.2%
More than one race
2
   2.8%
5
   7.5%
2
   4.9%
9
   5.0%
Unknown or Not Reported
0
   0.0%
1
   1.5%
0
   0.0%
1
   0.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants 67 participants 41 participants 180 participants
72 67 41 180
Positive culture result for N. gonorrhoeae  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 67 participants 41 participants 180 participants
57
  79.2%
56
  83.6%
28
  68.3%
141
  78.3%
1.Primary Outcome
Title Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm
Hide Description Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. Male participants were swabbed at the urethral site and female participants at the cervical site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the urethral/cervical site at baseline.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 57 56 28
Measure Type: Count of Participants
Unit of Measure: Participants
55
  96.5%
54
  96.4%
28
 100.0%
2.Primary Outcome
Title Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related.
Hide Description Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof was a congenital anomaly/birth defect; or may have jeopardized the subject or required intervention to prevent one of the outcomes. Relationship to study product was determined by the investigator and defined as a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.
Time Frame Day 1 through Day 31
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received the study treatment were included in the analysis population. One participant enrolled in the Ceftriaxone arm was pregnant at enrollment and therefore, not treated.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 72 67 40
Measure Type: Count of Participants
Unit of Measure: Participants
Related AEs
9
  12.5%
12
  17.9%
6
  15.0%
Related SAEs
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Microbiological Cure at Rectal Sites in Each Study Arm
Hide Description Microbiological cure was assessed at the TOC visit. Microbiological cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All participants were swabbed at the rectal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A subject was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was limited to participants who had a positive culture result at the rectal site for N. gonorrhoeae at baseline.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 5 7 3
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
7
 100.0%
3
 100.0%
4.Secondary Outcome
Title Number of Participants With Microbiological Cure at Pharyngeal Sites in Each Study Arm
Hide Description Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All subjects were swabbed at the pharyngeal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the pharyngeal site at baseline.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 8 11 4
Measure Type: Count of Participants
Unit of Measure: Participants
4
  50.0%
9
  81.8%
4
 100.0%
5.Secondary Outcome
Title Number of Participants With Clinical Cure in Each Study Arm
Hide Description A clinical cure was defined as the resolution of all signs and symptoms of gonorrhea (e.g. cervical/vaginal/urethral discharge, dysuria, dyspareunia, vulvovaginal irritation, sore throat) that were present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. A clinical failure was defined by the presence of any sign or symptom of gonorrhea that was also present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. The investigator also submitted his/her determination of whether the participant met or did not meet the criteria for clinical cure (or whether it is unknown if the participant met the criteria). In the event the investigator’s assessment of clinical cure did not coincide with the definitions of clinical cure/failure, the investigator’s assessment was the final adjudicator.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at any anatomical site and reported signs or symptoms of gonorrhea at baseline.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 57 49 27
Measure Type: Count of Participants
Unit of Measure: Participants
52
  91.2%
46
  93.9%
26
  96.3%
6.Secondary Outcome
Title Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Baseline.
Hide Description Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.
Time Frame Day 1 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 57 56 28
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   3.6%
7.Secondary Outcome
Title Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Day 6.
Hide Description Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at Day 6 with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 57 52 28
Measure Type: Count of Participants
Unit of Measure: Participants
48
  84.2%
42
  80.8%
25
  89.3%
8.Secondary Outcome
Title Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm
Hide Description Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the rectal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.
Time Frame Baseline and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was restricted to participants who had a positive rectal culture result for N. gonorrhoeae at baseline.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 5 7 3
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
0
   0.0%
0
   0.0%
0
   0.0%
Day 6
5
 100.0%
7
 100.0%
3
 100.0%
9.Secondary Outcome
Title Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm
Hide Description Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the pharyngeal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.
Time Frame Baseline and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was restricted to participants who had a positive pharyngeal culture result for N. gonorrhoeae at baseline.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 8 11 4
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
0
   0.0%
0
   0.0%
0
   0.0%
Day 6
2
  25.0%
6
  54.5%
2
  50.0%
10.Secondary Outcome
Title Median in Vitro Minimum Inhibitory Concentrations (MIC) Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Baseline
Hide Description For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the minimum inhibitory concentration (MIC) was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
Time Frame Day 1 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all participants who had isolates collected and results reported at the timepoint.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 57 56 27
Median (Full Range)
Unit of Measure: µg/mL
AZD0914/ETX0914
0.125
(0.008 to 0.250)
0.093
(0.008 to 0.250)
0.060
(0.008 to 0.250)
Ceftriaxone
0.008
(0.001 to 0.030)
0.008
(0.001 to 0.060)
0.004
(0.001 to 0.030)
11.Secondary Outcome
Title Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Day 6
Hide Description For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all participants who had isolates collected and results reported at the timepoint.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 2 1 0
Median (Full Range)
Unit of Measure: µg/mL
AZD0914/ETX0914
0.188
(0.125 to 0.250)
0.060
(0.060 to 0.060)
Ceftriaxone
0.012
(0.008 to 0.015)
0.001
(0.001 to 0.001)
12.Secondary Outcome
Title Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Baseline
Hide Description For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
Time Frame Day 1 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all participants who had isolates collected and results reported at the timepoint.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 5 6 3
Median (Full Range)
Unit of Measure: µg/mL
AZD0914/ETX0914
0.060
(0.030 to 0.125)
0.093
(0.060 to 0.250)
0.125
(0.008 to 0.250)
Ceftriaxone
0.004
(0.001 to 0.015)
0.008
(0.004 to 0.008)
0.004
(0.004 to 0.008)
13.Secondary Outcome
Title Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Day 6
Hide Description For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all participants who had isolates collected and results reported at the timepoint, of which there were none for this anatomical site and timepoint.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Baseline
Hide Description For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
Time Frame Day 1 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all participants who had isolates collected and results reported at the timepoint.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 8 11 4
Median (Full Range)
Unit of Measure: µg/mL
AZD0914/ETX0914
0.060
(0.030 to 0.250)
0.125
(0.008 to 0.250)
0.093
(0.060 to 0.250)
Ceftriaxone
0.008
(0.001 to 0.030)
0.008
(0.004 to 0.060)
0.006
(0.002 to 0.060)
15.Secondary Outcome
Title Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Day 6
Hide Description For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all participants who had isolates collected and results reported at the timepoint.
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description:
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
Overall Number of Participants Analyzed 4 2 0
Median (Full Range)
Unit of Measure: µg/mL
AZD0914/ETX0914
0.125
(0.060 to 0.250)
0.093
(0.060 to 0.125)
Ceftriaxone
0.012
(0.004 to 0.030)
0.012
(0.008 to 0.015)
Time Frame All serious and non-serious adverse events were collected for 30 days after study product administration
Adverse Event Reporting Description One enrolled participant was not subsequently treated and is not included in the number at risk.
 
Arm/Group Title AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Hide Arm/Group Description Participants receive single oral dose of 2000 mg of AZD0914/ETX0914. Participants receive single oral dose of 3000 mg of AZD0914/ETX0914. Participants receive single intramuscular dose of 500 mg of ceftriaxone.
All-Cause Mortality
AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/72 (0.00%)      1/67 (1.49%)      0/40 (0.00%)    
Injury, poisoning and procedural complications       
Gun shot wound * 1  0/72 (0.00%)  0 1/67 (1.49%)  1 0/40 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD0914/ETX0914 2000mg AZD0914/ETX0914 3000mg Ceftriaxone 500mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/72 (8.33%)      12/67 (17.91%)      11/40 (27.50%)    
Gastrointestinal disorders       
Diarrhoea * 1  4/72 (5.56%)  4 2/67 (2.99%)  2 3/40 (7.50%)  3
General disorders       
Injection Site Pain * 1 [1]  0/0  0 0/0  0 2/40 (5.00%)  2
Infections and infestations       
Gonorrhea * 1  1/72 (1.39%)  1 4/67 (5.97%)  4 3/40 (7.50%)  3
Urethritis * 1  1/72 (1.39%)  1 0/67 (0.00%)  0 3/40 (7.50%)  3
Nervous system disorders       
Headache * 1  0/72 (0.00%)  0 6/67 (8.96%)  6 2/40 (5.00%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.1)
[1]
Only the ceftriaxone arm received the study product via injection.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Stephanie N. Taylor, MD
Organization: Louisiana State University Health Sciences Center
Phone: (504) 658-2622
EMail: staylo2@lsuhsc.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02257918     History of Changes
Other Study ID Numbers: 14-0014
HHSN272201300012I
First Submitted: September 19, 2014
First Posted: October 7, 2014
Results First Submitted: December 15, 2016
Results First Posted: February 8, 2017
Last Update Posted: March 22, 2017