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Trial record 42 of 1173 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

Tracking Information
First Submitted Date  ICMJE July 27, 2006
First Posted Date  ICMJE July 31, 2006
Results First Submitted Date  ICMJE February 1, 2013
Results First Posted Date  ICMJE March 8, 2013
Last Update Posted Date August 15, 2018
Study Start Date  ICMJE January 2007
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2013)
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00358462 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
  • 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.
  • 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.
  • Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin [ Time Frame: baseline ]
    In vitro susceptibiities of M. genitalium to azithromycin
  • Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Doxycycline [ Time Frame: baseline ]
    In vitro susceptibilities of M. genitalium to doxycycline
  • Minimum Inhibitory Concentrations (MIC) of U. Ureaplasma Biovar 2 [ Time Frame: baseline ]
    In vitro susceptibilities of U. urealyticum biovar 2
  • Minimum Inhibitory Concentrations (MIC) of U. Parvum [ Time Frame: baseline ]
    In vitro susceptibilities of U. parvum
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)
Official Title  ICMJE 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
Brief Summary

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).

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Urethritis
Intervention  ICMJE
  • Drug: Azithromycin
    two 500mg tablets or four 250mg tablets administered as a single dose
    Other Names:
    • Zithromax
    • Zmax
  • Drug: Doxycycline
    one 100mg capsule administered twice daily for seven days
    Other Names:
    • Doryx
    • Doxychel
    • Monodox
    • Oracea
    • Periostat
    • Vibra-Tabs
    • Vibramycin
Study Arms  ICMJE
  • Active Comparator: Active azithromycin+placebo doxycycline
    Active azithromycin (1g) and placebo doxycycline
    Intervention: Drug: Azithromycin
  • Active Comparator: Active doxycycline+placebo azithromycin
    Active doxycycline and placebo azithromycin
    Intervention: Drug: Doxycycline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2012)
606
Original Enrollment  ICMJE
 (submitted: July 27, 2006)
900
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00358462
Other Study ID Numbers  ICMJE 26995
05-0143 (protocol number) ( Other Identifier: University of Washington )
U19AI031448 ( U.S. NIH Grant/Contract )
R01AI072728 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lisa Manhart, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Lisa E Manhart, PhD University of Washington
PRS Account University of Washington
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP