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Trial record 42 of 1169 for:    Sexually Transmitted Diseases | ( Map: United States ) | NIH

Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)

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: NCT00358462
Recruitment Status : Completed
First Posted : July 31, 2006
Results First Posted : March 8, 2013
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Lisa Manhart, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Urethritis
Interventions Drug: Azithromycin
Drug: Doxycycline
Enrollment 606
Recruitment Details Men were recruited from a sexually transmitted diseases clinic in Seattle, Washington from January 2007 to July 2011
Pre-assignment Details  
Arm/Group Title Active Azithromycin + Placebo Doxycycline Active Doxycycline + Placebo Azithromycin
Hide Arm/Group Description Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose Doxycycline : one 100mg capsule administered twice daily for seven days
Period Title: Overall Study
Started 304 302
Completed 245 238
Not Completed 59 64
Arm/Group Title Active Azithromycin + Placebo Doxycycline Active Doxycycline + Placebo Azithromycin Total
Hide Arm/Group Description Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose Doxycycline : one 100mg capsule administered twice daily for seven days Total of all reporting groups
Overall Number of Baseline Participants 304 302 606
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 304 participants 302 participants 606 participants
34.1  (9.8) 33.3  (10.1) 33.7  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 304 participants 302 participants 606 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
304
 100.0%
302
 100.0%
606
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 304 participants 302 participants 606 participants
304 302 606
1.Primary Outcome
Title mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit
Hide Description Microbiologic cure of M. genitalium at first follow-up visit (defined as a negative in-house PCR test performed on urine)
Time Frame approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population (defined as urethral symptoms or visible discharge plus >=5PMNs/HPF at baseline) who tested positive for M. genitalium at baseline
Arm/Group Title Active Azithromycin + Placebo Doxycycline Active Doxycycline + Placebo Azithromycin
Hide Arm/Group Description:
Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
Doxycycline : one 100mg capsule administered twice daily for seven days
Overall Number of Participants Analyzed 38 27
Measure Type: Number
Unit of Measure: participants
15 8
2.Primary Outcome
Title mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit
Hide Description Microbiologic cure, defined as negative PCR for U. urealyticum (if cultured), or negative culture at first follow-up visit
Time Frame 3 weeks (allowable window 2-5)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population (defined as urethral symptoms or visible discharge plus >=5PMNs/HPF at baseline) who tested positive for U. urealyticum at baseline
Arm/Group Title Active Azithromycin + Placebo Doxycycline Active Doxycycline + Placebo Azithromycin
Hide Arm/Group Description:
Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
Doxycycline : one 100mg capsule administered twice daily for seven days
Overall Number of Participants Analyzed 52 55
Measure Type: Number
Unit of Measure: participants
39 38
3.Secondary Outcome
Title Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit
Hide Description Proportion of men with M. genitalium at the initial study visit who had clinical cure, defined as <5 PMNs/HPF (with or without urethral symptoms) on a urethral Gram stain and absence of urethral discharge at follow-up.
Time Frame approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title Active Azithromycin+Placebo Doxycycline Active Doxycycline+Placebo Azithromycin
Hide Arm/Group Description:

Active azithromycin (1g) and placebo doxycycline

Azithromycin: two 500mg tablets or four 250mg tablets administered as a single dose

Active doxycycline and placebo azithromycin

Doxycycline: one 100mg capsule administered twice daily for seven days

Overall Number of Participants Analyzed 38 27
Measure Type: Number
Unit of Measure: participants
24 13
4.Secondary Outcome
Title Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit
Hide Description Proportion of men with Ureaplasma urealyticum at the initial study visit who had clinical cure, defined as <5 PMNs/HPF (with or without urethral symptoms) on a urethral Gram stain and absence of urethral discharge at follow-up.
Time Frame approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title Active Azithromycin+Placebo Doxycycline Active Doxycycline+Placebo Azithromycin
Hide Arm/Group Description:

Active azithromycin (1g) and placebo doxycycline

Azithromycin: two 500mg tablets or four 250mg tablets administered as a single dose

Active doxycycline and placebo azithromycin

Doxycycline: one 100mg capsule administered twice daily for seven days

Overall Number of Participants Analyzed 52 55
Measure Type: Number
Unit of Measure: participants
43 40
5.Secondary Outcome
Title Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin
Hide Description In vitro susceptibiities of M. genitalium to azithromycin
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with recovered isolates that successfully underwent in vitro assessment of antibiotic susceptibilities
Arm/Group Title Cultivated Isolates
Hide Arm/Group Description:
Azithromycin MIC's
Overall Number of Participants Analyzed 56
Measure Type: Count of Participants
Unit of Measure: Participants
MIC range <=0.001 - 0.004 ug/ml
31
  55.4%
MIC range >8 ug/ml
25
  44.6%
6.Secondary Outcome
Title Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Doxycycline
Hide Description In vitro susceptibilities of M. genitalium to doxycycline
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cultivated Isolates
Hide Arm/Group Description:
Cultivated M. genitalium isolates that successfully underwent in vitro MICs for doxycycline
Overall Number of Participants Analyzed 61
Median (Full Range)
Unit of Measure: MIC (ug/mL)
0.5
(0.125 to 2.0)
7.Secondary Outcome
Title Minimum Inhibitory Concentrations (MIC) of U. Ureaplasma Biovar 2
Hide Description In vitro susceptibilities of U. urealyticum biovar 2
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
isolates
Arm/Group Title Azithromycin Doxycycline Moxifloxacin
Hide Arm/Group Description:
Cultivated U. urealyticum biovar 2 isolates that successfully underwent in vitro MICs for azithromycin
Cultivated U. urealyticum biovar 2 isolates that successfully underwent in vitro MICs for doxycycliine
Cultivated U. urealyticum biovar 2 isolates that successfully underwent in vitro MICs for moxifloxacin
Overall Number of Participants Analyzed 22 22 22
Median (Full Range)
Unit of Measure: MIC (ug/mL)
1.00
(0.25 to 2.00)
0.5
(0.125 to 1.00)
0.5
(0.25 to 1.00)
8.Secondary Outcome
Title Minimum Inhibitory Concentrations (MIC) of U. Parvum
Hide Description In vitro susceptibilities of U. parvum
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
isolates
Arm/Group Title Azithromycin Doxycycline Moxifloxacin
Hide Arm/Group Description:
Cultivated U. parvum isolates that successfully underwent in vitro MICs for azithromycin
Cultivated U. parvum isolates that successfully underwent in vitro MICs for doxycycline
Cultivated U. parvum isolates that successfully underwent in vitro MICs for moxifloxacin
Overall Number of Participants Analyzed 8 8 8
Median (Full Range)
Unit of Measure: MIC (ug/mL)
0.5
(0.125 to 2.00)
0.25
(0.125 to 0.50)
0.25
(0.125 to 0.50)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Azithromycin + Placebo Doxycycline Active Doxycycline + Placebo Azithromycin
Hide Arm/Group Description Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose Doxycycline : one 100mg capsule administered twice daily for seven days
All-Cause Mortality
Active Azithromycin + Placebo Doxycycline Active Doxycycline + Placebo Azithromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active Azithromycin + Placebo Doxycycline Active Doxycycline + Placebo Azithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/304 (0.33%)      3/302 (0.99%)    
Eye disorders     
Optic neuritis *  0/304 (0.00%)  0 1/302 (0.33%)  1
Injury, poisoning and procedural complications     
Gun shot wound *  0/304 (0.00%)  0 1/302 (0.33%)  1
Broken leg *  0/304 (0.00%)  0 1/302 (0.33%)  1
Psychiatric disorders     
Unstable mental status *  1/304 (0.33%)  1 0/302 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Azithromycin + Placebo Doxycycline Active Doxycycline + Placebo Azithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/304 (17.43%)      56/302 (18.54%)    
Gastrointestinal disorders     
Nausea   28/304 (9.21%)  73 36/302 (11.92%)  68
Diarrhea   31/304 (10.20%)  74 35/302 (11.59%)  47
Other  [1]  12/304 (3.95%)  32 17/302 (5.63%)  32
General disorders     
Vomiting   6/304 (1.97%)  7 7/302 (2.32%)  7
Rash   6/304 (1.97%)  7 7/302 (2.32%)  7
Indicates events were collected by systematic assessment
[1]
flu, cold, URTI; STD/genital injury or pain; dizziness; injuries; dry mouth; non-rash skin condition);elective medical procedure; mild bleeding; sunburn; tightness in head, neck
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: Lisa E. Manhart, PhD - PI
Organization: University of Washington
Phone: 206-744-3646
EMail: lmanhart@uw.edu
Layout table for additonal information
Responsible Party: Lisa Manhart, University of Washington
ClinicalTrials.gov Identifier: NCT00358462     History of Changes
Other Study ID Numbers: 26995
05-0143 (protocol number) ( Other Identifier: University of Washington )
U19AI031448 ( U.S. NIH Grant/Contract )
R01AI072728 ( U.S. NIH Grant/Contract )
First Submitted: July 27, 2006
First Posted: July 31, 2006
Results First Submitted: February 1, 2013
Results First Posted: March 8, 2013
Last Update Posted: August 15, 2018