Trial · NCT00358462
Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)
NCT00358462, Phase 3, Completed, University of Washington; results first posted 2013-03-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA). Trials, record NCT00358462. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00358462
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)
- NCT number
- NCT00358462
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 606 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Urethritis
- Interventions
- Azithromycin, Doxycycline
- First posted
- 2006-07-31
- Last updated
- 2018-08-15
- Results first posted
- 2013-03-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit | approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit) | Microbiologic cure of M. genitalium at first follow-up visit (defined as a negative in-house PCR test performed on urine) |
| Primary | mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit | 3 weeks (allowable window 2-5) | Microbiologic cure, defined as negative PCR for U. urealyticum (if cultured), or negative culture at first follow-up visit |
| Secondary | Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit | approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit) | 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. |
| Secondary | Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit | approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit) | 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. |
| Secondary | Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin | baseline | In vitro susceptibiities of M. genitalium to azithromycin |
| Secondary | Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Doxycycline | baseline | In vitro susceptibilities of M. genitalium to doxycycline |
| Secondary | Minimum Inhibitory Concentrations (MIC) of U. Ureaplasma Biovar 2 | baseline | In vitro susceptibilities of U. urealyticum biovar 2 |
| Secondary | Minimum Inhibitory Concentrations (MIC) of U. Parvum | baseline | In vitro susceptibilities of U. parvum |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit | approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit) | mITT population (defined as urethral symptoms or visible discharge plus \>=5PMNs/HPF at baseline) who tested positive for M. genitalium at baseline | participants | NUMBER |
| PRIMARY | mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit | 3 weeks (allowable window 2-5) | mITT population (defined as urethral symptoms or visible discharge plus \>=5PMNs/HPF at baseline) who tested positive for U. urealyticum at baseline | participants | NUMBER |
| SECONDARY | Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit | approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit) | mITT population | participants | NUMBER |
| SECONDARY | Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit | approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit) | mITT population | participants | NUMBER |
| SECONDARY | Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin | baseline | Participants with recovered isolates that successfully underwent in vitro assessment of antibiotic susceptibilities | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Doxycycline | baseline | MIC (ug/mL) | MEDIAN | |
| SECONDARY | Minimum Inhibitory Concentrations (MIC) of U. Ureaplasma Biovar 2 | baseline | isolates | MIC (ug/mL) | MEDIAN |
| SECONDARY | Minimum Inhibitory Concentrations (MIC) of U. Parvum | baseline | isolates | MIC (ug/mL) | MEDIAN |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit | Active Azithromycin + Placebo Doxycycline | 15 | participants | ||
| mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit | Active Doxycycline + Placebo Azithromycin | 8 | participants | ||
| mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit | Active Azithromycin + Placebo Doxycycline | 39 | participants | ||
| mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit | Active Doxycycline + Placebo Azithromycin | 38 | participants | ||
| Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit | Active Azithromycin+Placebo Doxycycline | 24 | participants | ||
| Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit | Active Doxycycline+Placebo Azithromycin | 13 | participants | ||
| Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit | Active Azithromycin+Placebo Doxycycline | 43 | participants | ||
| Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit | Active Doxycycline+Placebo Azithromycin | 40 | participants | ||
| Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin | Cultivated Isolates | MIC range <=0.001 - 0.004 ug/ml | 31 | Participants | |
| Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin | Cultivated Isolates | MIC range >8 ug/ml | 25 | Participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Azithromycin + Placebo Doxycycline | 304 | |
| Overall Study | STARTED | Active Doxycycline + Placebo Azithromycin | 302 | |
| Overall Study | COMPLETED | Active Azithromycin + Placebo Doxycycline | 245 | |
| Overall Study | COMPLETED | Active Doxycycline + Placebo Azithromycin | 238 | |
| Overall Study | NOT COMPLETED | Active Azithromycin + Placebo Doxycycline | 59 | |
| Overall Study | NOT COMPLETED | Active Doxycycline + Placebo Azithromycin | 64 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Active Azithromycin + Placebo Doxycycline | 28 | 304 | 73 |
| other | Nausea | Gastrointestinal disorders | Active Doxycycline + Placebo Azithromycin | 36 | 302 | 68 |
| other | Diarrhea | Gastrointestinal disorders | Active Azithromycin + Placebo Doxycycline | 31 | 304 | 74 |
| other | Diarrhea | Gastrointestinal disorders | Active Doxycycline + Placebo Azithromycin | 35 | 302 | 47 |
| other | Vomiting | General disorders | Active Azithromycin + Placebo Doxycycline | 6 | 304 | 7 |
| other | Vomiting | General disorders | Active Doxycycline + Placebo Azithromycin | 7 | 302 | 7 |
| other | Rash | General disorders | Active Azithromycin + Placebo Doxycycline | 6 | 304 | 7 |
| other | Rash | General disorders | Active Doxycycline + Placebo Azithromycin | 7 | 302 | 7 |
| other | Other | Gastrointestinal disorders | Active Azithromycin + Placebo Doxycycline | 12 | 304 | 32 |
| other | Other | Gastrointestinal disorders | Active Doxycycline + Placebo Azithromycin | 17 | 302 | 32 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Azithromycin + Placebo Doxycycline | ||
| Total, all-cause mortality | Active Doxycycline + Placebo Azithromycin | ||
| Total, other adverse events | Active Azithromycin + Placebo Doxycycline | 53 | 304 |
| Total, other adverse events | Active Doxycycline + Placebo Azithromycin | 56 | 302 |
| Total, serious adverse events | Active Azithromycin + Placebo Doxycycline | 1 | 304 |
| Total, serious adverse events | Active Doxycycline + Placebo Azithromycin | 3 | 302 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01AI072728 | Ureaplasmas in acute and persistent urethritis: clinical implications | MANHART, LISA E | UNIVERSITY OF WASHINGTON | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2007 to 2010 | NIH RePORTER |
| U19AI031448 | University of Washington STI-TM Cooperative Research Center | HOLMES, KING K. | UNIVERSITY OF WASHINGTON | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 1995 to 2010 | NIH RePORTER |
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active Azithromycin + Placebo Doxycycline vs Active Doxycycline + Placebo Azithromycin: mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit | Trial comparisons |
| Active Azithromycin + Placebo Doxycycline vs Active Doxycycline + Placebo Azithromycin: mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit | Trial comparisons |
| Active Azithromycin+Placebo Doxycycline vs Active Doxycycline+Placebo Azithromycin: Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit | Trial comparisons |
| Active Azithromycin+Placebo Doxycycline vs Active Doxycycline+Placebo Azithromycin: Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit | Trial comparisons |
| Active Azithromycin + Placebo Doxycycline vs Active Doxycycline + Placebo Azithromycin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00358462
GET https://conductscience.org/api/trials/v1/NCT00358462/registered