Skip to main content
OpenTrials
Completed

NCT Number: NCT00358462

Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)

The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis.

Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination).

Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms.

Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urethritis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urethral Diseases Urogenital Diseases Urologic Diseases

Age range

16 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Public Health -- Seattle & King County Sexually Transmitted Diseases Clinic located at Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

OBJECTIVES

The primary objective of this study is to determine the relative effectiveness of azithromycin and doxycycline in eradicating Mycoplasma genitalium and Ureaplasmas among men with nongonococcal urethritis (NGU).

Secondary objectives of this study are to:

  • determine the sensitivity of persisting organisms to azithromycin and doxycycline by performing minimum inhibitory concentration (MIC) testing
  • determine the relationship between persistence/recurrence of clinical signs and persistent/recurrent detection of M. genitalium and Ureaplasmas among men with NGU treated with azithromycin or doxycycline, measured by follow-up clinical exams and repeated assays performed on specimens collected at follow-up study visits

STUDY DESCRIPTION

1200 men with NGU, ages 16 and older, will be enrolled in a randomized double-blinded treatment trial. Urine samples, oral swabs, and urethral swabs will be obtained from each subject at the initial clinic visit. Urine specimens will be tested for M. genitalium and Ureaplasma. Study participants will be randomly assigned to receive one of two pre-packaged treatments: active doxycycline plus placebo azithromycin or active azithromycin plus placebo doxycycline. Subjects will complete a questionnaire, and will be given a simple standardized log in which they will be asked to keep track of adherence to the study drug, record solicited adverse events, note when symptoms disappear and/or reappear, and document sexual activity between study visits.

Subjects who test positive for M. genitalium or Ureaplasmas at the initial clinic visit will be asked to return for at least two follow-up study visits: at approximately 3 and 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis and re-tested for M. genitalium and Ureaplasmas. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visits will receive a blinded treatment packet containing the alternate medication, or will be offered open-label moxifloxacin if the alternate treatment regimen was administered at the prior follow-up study visit. If additional treatment is administered at the 6-week follow-up study visit, a fourth study visit will be scheduled to occur approximately 9 or 10 weeks following the initial clinic visit.

Study participants who were negative for M. genitalium and Ureaplasma at enrollment will be asked to return for evaluation for a single follow-up study visit, approximately 3 weeks after the initial clinic visit. At this visit they will complete the follow-up questionnaire and provide specimens for future testing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has a visible urethral discharge or greater than or equal to 5 polymorphonuclear leukocytes (PMNs) per high power field on a Gram-stained slide of a urethral swab sample
  • Possesses and is willing to disclose valid contact information for follow-up
  • English-speaking
  • Gives informed consent
  • Exhibits understanding of study procedures
  • Exhibits ability to comply with study procedures for the entire length of the study

Exclusion criteria

  • Has previously participated in this study
  • Has taken antibiotics within the prior month
  • Has known allergies to tetracyclines or azithromycin
  • Is being treated with any of the following: warfarin, ergot derivatives, pimozide (Orap), propafenone (Rytmonorm, Rythmol), disopyramide (Norpace, Rythmodan), rifampin, digoxin, isotretinoin, or methotrexate
  • Has received a kidney, heart, or lung transplant.
  • Is undertaking concomitant systemic steroid therapy

Treatment and study plan

Azithromycin

Drug

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

Other names: Zithromax, Zmax

Doxycycline

Drug

one 100mg capsule administered twice daily for seven days

Other names: Doryx, Doxychel, Monodox, Oracea, Periostat, Vibra-Tabs, Vibramycin

Primary outcomes

  1. mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit

    Time frame: 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)

  2. mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit

    Time frame: 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 outcomes

  1. Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit

    Time frame: 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.

  2. Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit

    Time frame: 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.

  3. Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin

    Time frame: baseline

    In vitro susceptibiities of M. genitalium to azithromycin

  4. Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Doxycycline

    Time frame: baseline

    In vitro susceptibilities of M. genitalium to doxycycline

  5. Minimum Inhibitory Concentrations (MIC) of U. Ureaplasma Biovar 2

    Time frame: baseline

    In vitro susceptibilities of U. urealyticum biovar 2

  6. Minimum Inhibitory Concentrations (MIC) of U. Parvum

    Time frame: baseline

    In vitro susceptibilities of U. parvum

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Mycoplasma Genitalium Antibiotic Susceptibility and Treatment: A Randomized Double-blind Trial of the Efficacy of Azithromycin and Doxycycline for Clinical and Microbiological Cure of M. Genitalium in Men With Nongonococcal Urethritis

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 31, 2006
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.