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Efficacy of Combination Therapies for Gonorrhea Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00926796
First received: June 23, 2009
Last updated: January 30, 2014
Last verified: June 2013
Results First Received: November 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gonococcal Infections
Interventions: Drug: Gentamicin
Drug: Gemifloxacin
Drug: Azithromycin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited in outpatient STD clinics located in 5 cities across the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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lab results were not available at randomization, participants who were found to be negative for Gonorrhea were withdrawn after randomization as they did not meet one of the eligibility criteria.

Reporting Groups
  Description
Regimen A: Gentamicin Plus Azithromycin 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.
Regimen B: Gemifloxacin Plus Azithromycin Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.

Participant Flow:   Overall Study
    Regimen A: Gentamicin Plus Azithromycin     Regimen B: Gemifloxacin Plus Azithromycin  
STARTED     309 [1]   305 [1]
COMPLETED     202 [2]   199 [2]
NOT COMPLETED     107     106  
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per protocol population. See participant flow.

Reporting Groups
  Description
Regimen A: Gentamicin Plus Azithromycin 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.
Regimen B: Gemifloxacin Plus Azithromycin Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
Total Total of all reporting groups

Baseline Measures
    Regimen A: Gentamicin Plus Azithromycin     Regimen B: Gemifloxacin Plus Azithromycin     Total  
Number of Participants  
[units: participants]
  202     199     401  
Age  
[units: participants]
     
<=18 years     6     3     9  
Between 18 and 65 years     196     196     392  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  30  ± 9.9     30  ± 9.6     30  ± 9.8  
Gender  
[units: participants]
     
Female     19     21     40  
Male     183     178     361  
Region of Enrollment  
[units: participants]
     
United States     202     199     401  



  Outcome Measures
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1.  Primary:   Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection   [ Time Frame: 10-17 days after treatment. ]

2.  Primary:   Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection   [ Time Frame: 10-17 days after treatment. ]

3.  Secondary:   Eradication of Rectal Infection   [ Time Frame: 10-17 days after treatment. ]

4.  Secondary:   Eradication of Pharyngeal Infection   [ Time Frame: 10-17 days after treatment. ]

5.  Secondary:   Antimicrobial Susceptibility Profile of Treatment Failures.   [ Time Frame: Isolates obtained at enrollment (Day 0). ]

6.  Secondary:   Clinical Profile of Treatment Failures.   [ Time Frame: 10-17 days ]

7.  Secondary:   Resolution of Symptoms and Signs (Clinical Cure)   [ Time Frame: 10-17 days after treatment. ]

8.  Secondary:   Antimicrobial Susceptibility Profile of Enrollment Isolates.   [ Time Frame: Isolates obtained at enrollment (Day 0). ]

9.  Secondary:   Number of Participants With Adverse Events for Each Regimen   [ Time Frame: Day 0 through Day 30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: sylensing@uams.edu


No publications provided


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00926796     History of Changes
Other Study ID Numbers: 08-0042
Study First Received: June 23, 2009
Results First Received: November 25, 2013
Last Updated: January 30, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration