Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lisa Manhart, University of Washington
ClinicalTrials.gov Identifier:
NCT00358462
First received: July 27, 2006
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention Phase
Urethritis
Drug: Azithromycin
Drug: Doxycycline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Microbiologic cure of M. genitalium at first follow-up visit (defined as a negative in-house PCR test performed on urine)

  • mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit [ Time Frame: 3 weeks (allowable window 2-5) ] [ Designated as safety issue: No ]
    Microbiologic cure, defined as negative PCR for U. urealyticum (if cultured), or negative culture at first follow-up visit


Secondary Outcome Measures:
  • Minimum Inhibitory Concentrations (MIC) of All Cultivable Strains of M. Genitalium and Ureaplasmas [ Time Frame: on-going ] [ Designated as safety issue: No ]
  • Clinical Cure as Measured by the Absence of Recurrent or Persistent Signs and/or Symptoms of Urethral Infection Among Case Subjects Who Were Positive for M. Genitalium or 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) ] [ Designated as safety issue: No ]

Enrollment: 606
Study Start Date: January 2007
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active azithromycin+placebo doxycycline
Active azithromycin (1g) and placebo doxycycline
Drug: Azithromycin
two 500mg tablets or four 250mg tablets administered as a single dose
Other Names:
  • Zithromax
  • Zmax
Active Comparator: Active doxycycline+placebo azithromycin
Active doxycycline and placebo azithromycin
Drug: Doxycycline
one 100mg capsule administered twice daily for seven days
Other Names:
  • Doryx
  • Doxychel
  • Monodox
  • Oracea
  • Periostat
  • Vibra-Tabs
  • Vibramycin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358462

Locations
United States, Washington
Public Health -- Seattle & King County Sexually Transmitted Diseases Clinic located at Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Lisa E Manhart, PhD University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa Manhart, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00358462     History of Changes
Other Study ID Numbers: 26995-D, 05-0143 (protocol number), U19AI031448, R01AI072728
Study First Received: July 27, 2006
Results First Received: February 1, 2013
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
NGU, M genitalium, Ureaplasma, azithromycin, doxycycline

Additional relevant MeSH terms:
Disease Susceptibility
Pleuropneumonia
Mycoplasma Infections
Urethritis
Disease Attributes
Pathologic Processes
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Urethral Diseases
Urologic Diseases
Anti-Bacterial Agents
Doxycycline
Azithromycin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 20, 2014