Urinary Tract Infection
Conditions
Keywords
UTI
Brief summary
Urinary tract infection (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20s. One of the most common antibiotics used to treat UTIs is ciprofloxacin, usually for a total of three days. However, increasing resistance to this antibiotic has raised concerns about its overuse for cystitis and generated interest in alternative agents. An alternative antibiotic which is approved for use in UTIs is cefpodoxime. However, there are few studies evaluating the efficacy and tolerance of this compound when given in a 3-day regimen as is commonly used for treatment of UTI. The major purpose of this study is to assess the efficacy and tolerance of a 3-day regimen of cefpodoxime versus ciprofloxacin for treatment of acute uncomplicated cystitis.
Detailed description
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 and peri-urethral sample and then are randomly assigned to one of the two treatment groups.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.Follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.
Interventions
DRUGCefpodoxime
Cefpodoxime 100mg twice a day(BID)for 3 days
DRUGCiprofloxacin
Ciprofloxacin 250mg twice a day (BID)for 3 days
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Nonpregnant females in good general health with symptoms of acute cystitis
Exclusion criteria
* Pregnant,lactating, or not regularly contracepting: known anatomic abnormalities of the urinary tract; use of prophylactic antibiotics; history of allergy or intolerance to any of the study drugs; recent (\>2 weeks)exposure to an oral or parenteral antimicrobial; or history of UTI in the previous 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure | 28-30 days post therapy | Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiologic Cure | 1-15 days post therapy | Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ciprofloxacin Ciprofloxacin 250 mg BID X 3 days | 150 |
| Cefpodoxime Cefpodoxime 100 mg BID X 3 days | 150 |
| Total | 300 |
Baseline characteristics
| Characteristic | Ciprofloxacin | Cefpodoxime | Total |
|---|---|---|---|
| Age, Continuous | 24 years | 23 years | 24 years |
| Region of Enrollment United States | 150 participants | 150 participants | 300 participants |
| Sex: Female, Male Female | 150 Participants | 150 Participants | 300 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 41 / 137 | 37 / 137 |
| serious Total, serious adverse events | 0 / 150 | 0 / 150 |
Outcome results
Primary
Clinical Cure
Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin
Time frame: 28-30 days post therapy
Population: modified ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciprofloxacin | Clinical Cure | Cure | 140 participants |
| Ciprofloxacin | Clinical Cure | Not cure | 10 participants |
| Cefpodoxime | Clinical Cure | Cure | 123 participants |
| Cefpodoxime | Clinical Cure | Not cure | 27 participants |
Secondary
Microbiologic Cure
Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up
Time frame: 1-15 days post therapy
Population: Per protocol. Participants were eligible for analysis if they had an enrollment urine containing uropathogens and a urine specimen taken at follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciprofloxacin | Microbiologic Cure | Cure | 123 participants |
| Ciprofloxacin | Microbiologic Cure | Not cure | 5 participants |
| Cefpodoxime | Microbiologic Cure | Cure | 104 participants |
| Cefpodoxime | Microbiologic Cure | Not cure | 25 participants |