Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391651
Status:
COMPLETED
Last Update Posted:
2014-06-05
First Post:
2006-10-20
Brief Title:
Short Course Nitrofurantoin for Acute Cystitis
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Short Course Nitrofurantoin For Acute Cystitis
Status:
COMPLETED
Status Verified Date:
2014-06
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 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 trimethoprimsulfamethoxazone 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urine sample for analysis They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time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
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
Detailed Description:
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 trimethoprimsulfamethoxazone 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
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
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 |
|---|---|---|---|
| 01-1002-A 07 | None | None | None |