Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358462
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2006-07-27
Brief Title:
Mycoplasma Genitalium Antibiotic Susceptibility and Treatment MEGA
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 5PMNsHPF on a Gram-stained slide prepared from urethral exudates andor 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 andor 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 andor Ureaplasmas will be re-tested for these organisms
Study participants with signs andor 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 andor 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
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 5PMNsHPF on a Gram-stained slide prepared from urethral exudates andor 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 andor 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 andor Ureaplasmas will be re-tested for these organisms
Study participants with signs andor 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 andor 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 persistencerecurrence of clinical signs and persistentrecurrent 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 andor 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 andor 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
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 persistencerecurrence of clinical signs and persistentrecurrent 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 andor 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-0143 protocol number | OTHER | None | None |
| U19AI031448 | NIH | None | None |
| R01AI072728 | NIH | University of Washington | httpsreporternihgovquickSearchR01AI072728 |