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Efficacy of Combination Therapies for Gonorrhea Treatment

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ClinicalTrials.gov Identifier: NCT00926796
Recruitment Status : Completed
First Posted : June 24, 2009
Results First Posted : March 20, 2014
Last Update Posted : August 19, 2015
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;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gonorrhoea
Interventions Drug: Azithromycin
Drug: Gentamicin
Drug: Gemifloxacin
Enrollment 614
Recruitment Details Participants were recruited in outpatient STD clinics located in 5 cities across the United States.
Pre-assignment Details Since Gonorrhea lab results were not available at randomization, participants who were found to be negative for Gonorrhea were withdrawn after randomization as they did not meet one of the eligibility criteria.
Arm/Group Title Regimen A: Gentamicin Plus Azithromycin Regimen B: Gemifloxacin Plus Azithromycin
Hide Arm/Group Description Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time. Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
Period Title: Overall Study
Started 309 [1] 305 [1]
Completed 202 [2] 199 [2]
Not Completed 107 106
Reason Not Completed
Did not receive randomized treatment             4             7
Ineligible, negative for gonorrhea             57             60
Ineligible, but positive for gonorrhea             1             1
Adverse Event             7             14
Lost to Follow-up             22             13
Protocol Violation             15             11
Withdrawal by Subject             1             0
[1]
Number randomized
[2]
Number eligible and in the full analysis set
Arm/Group Title Regimen A: Gentamicin Plus Azithromycin Regimen B: Gemifloxacin Plus Azithromycin Total
Hide Arm/Group Description Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time. Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time. Total of all reporting groups
Overall Number of Baseline Participants 202 199 401
Hide Baseline Analysis Population Description
Per protocol population. See participant flow.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 199 participants 401 participants
<=18 years
6
   3.0%
3
   1.5%
9
   2.2%
Between 18 and 65 years
196
  97.0%
196
  98.5%
392
  97.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 202 participants 199 participants 401 participants
30  (9.9) 30  (9.6) 30  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 199 participants 401 participants
Female
19
   9.4%
21
  10.6%
40
  10.0%
Male
183
  90.6%
178
  89.4%
361
  90.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 202 participants 199 participants 401 participants
202 199 401
1.Primary Outcome
Title Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection
Hide Description Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)
Time Frame 10-17 days after treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)
Arm/Group Title Regimen A: Gentamicin Plus Azithromycin
Hide Arm/Group Description:
Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
Overall Number of Participants Analyzed 202
Measure Type: Number
Unit of Measure: percentage of participants
100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regimen A: Gentamicin Plus Azithromycin
Comments The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is <95%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Exact binomial confidence limit
Comments If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is <95% is rejected.
Method of Estimation Estimation Parameter Proportion of cured participants
Estimated Value 100
Confidence Interval (1-Sided) 95%
98.53
Estimation Comments When the lower 95% confidence limit is >=95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly >=95%).
2.Primary Outcome
Title Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection
Hide Description Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)
Time Frame 10-17 days after treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)
Arm/Group Title Regimen B: Gemifloxacin Plus Azithromycin
Hide Arm/Group Description:
Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
Overall Number of Participants Analyzed 199
Measure Type: Number
Unit of Measure: percentage of participants
99.50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regimen B: Gemifloxacin Plus Azithromycin
Comments The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is <95%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Exact bionomial confidence limit
Comments If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is <95% is rejected.
Method of Estimation Estimation Parameter Proportion of cured participants
Estimated Value 99.50
Confidence Interval (1-Sided) 95%
97.64
Estimation Comments When the lower 95% confidence interval is above 95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly >=95%).
3.Secondary Outcome
Title Eradication of Rectal Infection
Hide Description Number of enrollees with positive rectal culture at enrollment who have negative culture 10-17 days after treatment
Time Frame 10-17 days after treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who were positive for rectal gonorrhea at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)
Arm/Group Title Regimen A: Gentamicin Plus Azithromycin Regimen B: Gemifloxacin Plus Azithromycin
Hide Arm/Group Description:
Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
Overall Number of Participants Analyzed 1 5
Measure Type: Number
Unit of Measure: participants
1 5
4.Secondary Outcome
Title Eradication of Pharyngeal Infection
Hide Description Number of enrollees with positive pharyngeal culture at enrollment who have negative culture 10-17 days after treatment
Time Frame 10-17 days after treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who were positive for pharyngeal gonorrhea at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)
Arm/Group Title Regimen A: Gentamicin Plus Azithromycin Regimen B: Gemifloxacin Plus Azithromycin
Hide Arm/Group Description:
Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
Overall Number of Participants Analyzed 10 15
Measure Type: Number
Unit of Measure: participants
10 15
5.Secondary Outcome
Title Antimicrobial Susceptibility Profile of Treatment Failures.
Hide Description For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), the minimum inhibitory concentrations for various antimicrobial agents (Azithromycin, Cefixime, Ceftriaxone, Ciprofloxacin, Gemifloxacin, Gentamicin, Penicillin, Tetracycline).
Time Frame Isolates obtained at enrollment (Day 0).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.) with treatment failure.
Arm/Group Title Regimen A: Gentamicin Plus Azithromycin Regimen B: Gemifloxacin Plus Azithromycin
Hide Arm/Group Description:
Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
Overall Number of Participants Analyzed 0 1
Median (Full Range)
Unit of Measure: micrograms/milliliter
Azithromycin
0.25 [1] 
(NA to NA)
Cefixime
0.015 [1] 
(NA to NA)
Ceftriaxone
0.004 [1] 
(NA to NA)
Ciprofloxacin
0.002 [1] 
(NA to NA)
Gemifloxacin
0.004 [1] 
(NA to NA)
Gentamicin
4 [1] 
(NA to NA)
Penicillin
0.5 [1] 
(NA to NA)
Tetracycline
0.25 [1] 
(NA to NA)
[1]
Because data was available for only 1 participant, Measure of Dispersion could not be calculated.
6.Secondary Outcome
Title Clinical Profile of Treatment Failures.
Hide Description For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), number participants with clinical symptoms (vaginal/urethral discharge, dysuria, dyspareunia) at 10-17 days.
Time Frame 10-17 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had clinical symptoms at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.) with treatment failure.
Arm/Group Title Regimen A: Gentamicin Plus Azithromycin Regimen B: Gemifloxacin Plus Azithromycin
Hide Arm/Group Description:
Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: participants
Vaginal/urethral discharge 0
Dysuria 0
Dyspareunia 0
7.Secondary Outcome
Title Resolution of Symptoms and Signs (Clinical Cure)
Hide Description Number of participants whose gonorrhea-related symptoms (e.g. vaginal/urethral discharge, dysuria, dyspareunia) present at enrollment has resolved by visit 2.
Time Frame 10-17 days after treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had clinical symptoms at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)
Arm/Group Title Regimen A: Gentamicin Plus Azithromycin Regimen B: Gemifloxacin Plus Azithromycin
Hide Arm/Group Description:
Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
Overall Number of Participants Analyzed 188 182
Measure Type: Number
Unit of Measure: participants
179 177
8.Secondary Outcome
Title Antimicrobial Susceptibility Profile of Enrollment Isolates.
Hide Description Minimum inhibitory concentration (micrograms/milliliter) of pretreatment gonorrhea isolates collected from participants
Time Frame Isolates obtained at enrollment (Day 0).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol population (all randomized participants who too study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.).
Arm/Group Title Baseline
Hide Arm/Group Description:
All per protocol participants at baseline with evaluable isolates
Overall Number of Participants Analyzed 396
Median (Full Range)
Unit of Measure: micrograms/milliliter
Azithromycin
0.25
(0.03 to 16)
Cefixime
0.015
(0.001 to 1.0)
Ceftriaxone
0.008
(0.001 to 0.125)
Ciprofloxacin
0.004
(0.002 to 32)
Gemifloxacin
0.004
(0.001 to 8)
Gentamicin
4
(0.002 to 16)
Penicillin
0.5
(0.004 to 64)
Tetracycline
0.5
(0.03 to 32)
9.Secondary Outcome
Title Number of Participants With Adverse Events for Each Regimen
Hide Description Number of treated participants experiencing mild, moderate, severe, or life-threatening adverse events (AEs) either temporarily associated or not associated with study product.
Time Frame Day 0 through Day 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving study medication comprised the safety population. Of 614 participants randomized, 603 received study medication.
Arm/Group Title Regimen A: Gentamicin Plus Azithromycin Regimen B: Gemifloxacin Plus Azithromycin
Hide Arm/Group Description:
Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
Overall Number of Participants Analyzed 305 298
Measure Type: Number
Unit of Measure: participants
157 185
Time Frame Enrollment, at follow-up, which as targeted 10-17 days, and through 30 days.
Adverse Event Reporting Description All participants who received study medication comprise the number of participants at risk.
 
Arm/Group Title Regimen A: Gentamicin Plus Azithromycin Regimen B: Gemifloxacin Plus Azithromycin
Hide Arm/Group Description Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time. Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
All-Cause Mortality
Regimen A: Gentamicin Plus Azithromycin Regimen B: Gemifloxacin Plus Azithromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Regimen A: Gentamicin Plus Azithromycin Regimen B: Gemifloxacin Plus Azithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/305 (0.00%)      0/298 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Regimen A: Gentamicin Plus Azithromycin Regimen B: Gemifloxacin Plus Azithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   124/305 (40.66%)      164/298 (55.03%)    
Gastrointestinal disorders     
Diarrhea  1  53/305 (17.38%)  53 66/298 (22.15%)  67
Nausea  1  79/305 (25.90%)  79 120/298 (40.27%)  121
Vomiting  1  32/305 (10.49%)  32 42/298 (14.09%)  44
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
After the SMC meeting held during August 2012, the SMC recommended halting trial enrollment because continued participant accrual to targeted enrollment of 500 infected participants would be highly unlikely to alter the results.
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
Name/Title: Shelly Lensing
Organization: University of Arkansas for Medical Sciences
Phone: 501-686-8203
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00926796     History of Changes
Other Study ID Numbers: 08-0042
First Submitted: June 23, 2009
First Posted: June 24, 2009
Results First Submitted: November 25, 2013
Results First Posted: March 20, 2014
Last Update Posted: August 19, 2015