Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322465
Status:
COMPLETED
Last Update Posted:
2019-03-01
First Post:
2006-05-04
Brief Title:
NGU Doxycycline Plus or Minus Tinidazole Versus Azithromycin Plus or Minus Tinidazole
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Randomized Placebo-Controlled Double-Blind 4-Arm Trial for the Treatment of Non-Gonococcal Urethritis NGU Doxycycline Plus or Minus Tinidazole Versus Azithromycin Plus or Minus Tinidazole
Status:
COMPLETED
Status Verified Date:
2011-05
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:
This study will look at the safety effectiveness and tolerability of combination medications for the initial treatment of non-gonococcal urethritis NGU NGU is inflammation of the tube that carries urine from the bladder NGU is caused by bacteria that may be passed from person to person during sex This study will compare the 2 currently recommended NGU treatments doxycycline and azithromycin taken with tinidazole another medication to treat certain sexually transmitted infections Tinidazole used with doxycycline or azithromycin may cure NGU better than when doxycycline or azithromycin is used alone Study participants will be 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in Birmingham AL New Orleans LA Durham NC and Baltimore MD Study participation will last 7 weeks and involve 3 visits At each visit participants will provide a urine sample have 2 urethral swabs and have their urethra checked for discharge indicating infection
Detailed Description:
This study represents a clinical evaluation of the use of combination therapy for the initial treatment of non-gonococcal urethritis NGU This study will provide more current data on the comparison of cure rates between the 2 currently recommended therapies for NGU doxycycline and azithromycin Emerging clinical data has suggested that the latter may have become more efficacious for NGU as it is more effective in eradicating Mycoplasma M genitalium from the genital tract than the former Only in vitro data limited as it is suggests that doxycycline should be active against M genitalium The researchers hypothesize that cure rates for NGU will be significantly improved for both doxycycline and azithromycin using combination therapy with tinidazole Important safety and tolerability data will be collected with regards to the use of combination therapy Additionally the study will provide data on the prevalence of the targeted pathogens in 4 geographic areas and on characteristics of men with NGU that may help to target populations who would benefit the most from combination therapy The researchers hypothesize that currently recommended initial therapies for NGU are inadequate in at least certain populations due to lack of coverage for Trichomonas T vaginalis The researchers further hypothesize that between the 2 currently recommended regimens azithromycin will result in a greater number of cures than doxycycline due to its greater efficacy in M genitalium infected men The primary study objectives are to compare the clinical cure rates of doxycycline versus doxycycline with tinidazole and azithromycin versus azithromycin with tinidazole for the treatment of NGU and to evaluate the safety and tolerability of doxycyclinetinidazole and azithromycintinidazole in the treatment of NGU Secondary study objectives are to evaluate microbiological cure of Chlamydia C trachomatis T vaginalis M genitalium in men treated with doxycycline versus doxycycline with tinidazole and azithromycin versus azithromycin with tinidazole Analysis will also include doxycycline plus doxycyclinetinidazole versus azithromycin plus azithromycintinidazole for the clinical cure rates analysis will also include doxycycline plus doxycyclinetinidazole versus azithromycin plus azithromycintinidazole determine the prevalence of C trachomatis T vaginalis and M genitalium in the study population of men with non-gonococcal urethritis determine clinical behavioral and demographic predictors of the above organisms in men with non-gonococcal urethritis and collect specimens for future studies to determine the role of unique and novel pathogens in the etiology of non-gonococcal urethritis Outcome measures include clinical failure clinical cure microbiological cure and unevaluable cure assessed at the first and second follow-up visits Study participants will include 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in Birmingham AL New Orleans LA Durham NC and Baltimore MD Subjects will be randomly assigned to 1 of 4 active treatment arms 75 subjects doxycycline 75 subjects doxycycline plus tinidazole 75 subjects azithromycin and 75 subjects azithromycin plus tinidazole
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