A Phase 2 interventional study of Nitrofurantoin 100mg twice daily x 5 days and TMP/SMX DS twice daily x 3 days in Urinary Tract Infection, sponsored by University of Washington. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-05.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
The purpose of this research study is to determine what the cure rates are with a 5 day course of nitrofurantoin versus the more standard 3 day course of trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and what length of therapy is best for treatment of UTI, taking into account the problem of antibiotic resistance.
Procedures subjects will undergo once they have read and signed the consent are:
Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine sample and then randomly assigned to one of the two treatment groups.
will be obtained at each visit. If they were assigned to the nitrofurantoin treatment regimen, they will also be asked to collect a urine sample at home on the third day. If the subject develops recurrent urinary symptoms or does not have resolution of symptoms after completing the initial treatment course, they will be asked to return to the clinic and provide another urine sample for analysis. They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time.
The study population is women ages 18-45 with acute symptoms of a UTI without a history of UTI in the past 6 weeks.
The purpose of this research study is to determine what the cure rates are with a 5 day course of nitrofurantoin versus the more standard 3 day course of trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and what length of therapy is best for treatment of UTI, taking into account the problem of antibiotic resistance.
Procedures subjects will undergo once they have read and signed the consent are:
Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine sample and then randomly assigned to one of the two treatment groups. The randomization is generated by a Research Scientist working with the study.
They will be given a sheet to record symptoms at home. They will be asked to return to the clinic in 5-9 and 28-30 days after completing antibiotic therapy. Urine cultures will be obtained at each visit. If they were assigned to the nitrofurantoin treatment regimen, they will also be asked to collect a urine sample at home on the third day. If the subject develops recurrent urinary symptoms or does not have resolution of symptoms after completing the initial treatment course, they will be asked to return to the clinic and provide another urine sample for analysis. They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time.
The study population is women ages 18-45 with acute symptoms of a UTI without a history of UTI in the past 6 weeks.
779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.
This study's enrollment of 338 is above the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Exclusion Criteria:
Nitrofurantoin 100mg BID x 5 days
Drug: Nitrofurantoin 100mg twice daily x 5 days · Drug: TMP/SMX DS twice daily x 3 days
TMP/SMX DS BID x 3 days
Drug: TMP/SMX DS twice daily x 3 days
Nitrofurantoin 100mg twice daily x 5 days
Also known as: Macrobid
TMP/SMX DS twice daily x 3 days
Also known as: Septra
Microbiological Cure
Time frame: 28-30 days post therapy
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nitrofurantoin