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This is a prospective, Phase 4, open label, multi-center study of the clinical and microbiologic efficacy of ciprofloxacin for the treatment of uncomplicated urinary tract infections in adult women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofloxacin | Experimental | Ciprofloxacin for the treatment of uncomplicated urinary tract infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin | Drug | Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Combined Clinical and Microbiologic Response | Clinical response is defined as complete resolution of uUTI symptoms at entry and no new uUTI symptoms; microbiologic success is defined as eradication of baseline pathogen | From start of treatment until assessment of cure, approximately 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiologic Response | Microbiologic response is defined as demonstrating <1000 colony-forming units per mL of the baseline uropathogen at the test of cure visit | From start of treatment until assessment of cure, approximately 12 days |
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Inclusion Criteria:
Female patients ≥18 years of age with more than 24 hours of urinary symptoms attributable to a UTI
Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain, gross hematuria
A mid-stream urine specimen with:
Has given written informed consent to participate in the study.
Exclusion Criteria:
Only females are eligible to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Steven Aronin, MD | Iterum Therapeutics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Restore Clinical Research | Cary | North Carolina | 27518 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ciprofloxacin | Ciprofloxacin for the treatment of uncomplicated urinary tract infection Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ciprofloxacin | Ciprofloxacin for the treatment of uncomplicated urinary tract infection Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Combined Clinical and Microbiologic Response | Clinical response is defined as complete resolution of uUTI symptoms at entry and no new uUTI symptoms; microbiologic success is defined as eradication of baseline pathogen | Microbiological modified intent to treat population | Posted | Count of Participants | Participants | From start of treatment until assessment of cure, approximately 12 days |
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From start of treatment until assessment of cure, approximately 12 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ciprofloxacin | Ciprofloxacin for the treatment of uncomplicated urinary tract infection Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Development | Iterum Therapeutics | 18606614035 | saronin@iterumtx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2018 | Jul 26, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2019 | Jul 31, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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Open label study of ciprofloxacin for uncomplicated urinary tract infection
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body-mass index | Mean | Standard Deviation | kg/m^2 |
|
| Participants |
|
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| Secondary | Microbiologic Response | Microbiologic response is defined as demonstrating <1000 colony-forming units per mL of the baseline uropathogen at the test of cure visit | Microbiological modified intent to treat | Posted | Count of Participants | Participants | From start of treatment until assessment of cure, approximately 12 days |
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| 0 |
| 242 |
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| 242 |
Investigator may publish/present results provided the following are satisfied: (i) Sponsor consents to publication; (ii) Multi-Center Publication published; or at least 18 months since database lock; (iii) investigator must submit proposed publication to Sponsor for review, allowing at least 60 days to review. The Investigator shall delay publication/presentation for up to 45 days to permit the Sponsor time to obtain Intellectual Property protections and protect confidential information.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |