UTI - Lower Urinary Tract InfectionPhase 4NCT03366207
Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI)
A Phase 4 study testing Ciprofloxacin in people with UTI - Lower Urinary Tract Infection and Antibiotic Resistant Infection, run by Iterum Therapeutics, International Limited at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- UTI - Lower Urinary Tract Infection, Antibiotic Resistant Infection
- What is being tested?
- Ciprofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 26 Oct 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- a dipstick analysis positive for nitrite AND
- a dipstick analysis positive for leukocyte esterase
- Has given written informed consent to participate in the study.
Who cannot join
- Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature > 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea and/or vomiting
- Receipt of prior effective antibacterial drug therapy for uUTI for the presenting illness unless the recovered pathogen demonstrates resistance to initial antibiotic and clinical symptoms persist
- Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in patients with uUTI
- Patients with ileal loops or urinary stoma
- Patients with an indwelling urinary catheter in the previous 30 days
- Patients with paraplegia
Show all 18Show fewer
- Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
- Any history of trauma to the pelvis or urinary tract
- Patient's urine culture results, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a potential fungal pathogen
- Patient's urine culture results, if available at study entry, identifies the causative uropathogen for the presenting illness to be resistant to ciprofloxacin
- Patient has severe chronic kidney disease, or is receiving hemodialysis or peritoneal dialysis or had a renal transplant
- Patient is known to have severe neutropenia
- Patient is known to be pregnant
- Patients with uncontrolled diabetes mellitus
- Patients with a known history of myasthenia gravis
- Patients who require concomitant administration of tizanidine
- Patients with a history of allergy to quinolones
- Patient is considered unlikely to survive the study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
Trial locations and contacts
1 site in 1 country.
United States1 site
Restore Clinical Research
Cary, North Carolina, 27518
About this study
Official title: Clinical and Microbiologic Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection in Adult Women.
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.
- Being tested
- Ciprofloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Also called Cipro
Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin | Experimental | Ciprofloxacin for the treatment of uncomplicated urinary tract infection Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From start of treatment until assessment of cure, approximately 12 days
Secondary outcomes (1)
Microbiologic Response
Microbiologic response is defined as demonstrating <1000 colony-forming units per mL of the baseline uropathogen at the test of cure visit
Measured: From start of treatment until assessment of cure, approximately 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start15 Dec 2017
- Primary completion31 Jul 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UTI - Lower Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label study of ciprofloxacin for uncomplicated urinary tract infection
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iterum Therapeutics, International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Aronin, MD, Principal investigator, Iterum Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366207
- Sponsor's protocol ID
- IT004-401
- Status last verified
- Jul 2019
- First submitted
- 4 Dec 2017
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiologic Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection in Adult Women.
- ClinicalTrials.gov ID
- NCT03366207
- Acronym / sponsor ID
- IT004-401
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Iterum Therapeutics, International LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Posted 21 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label study of ciprofloxacin for uncomplicated urinary tract infection
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin | Experimental | Drug: CiprofloxacinCiprofloxacin for the treatment of uncomplicated urinary tract infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature > 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea and/or vomiting
- Receipt of prior effective antibacterial drug therapy for uUTI for the presenting illness unless the recovered pathogen demonstrates resistance to initial antibiotic and clinical symptoms persist
- Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in patients with uUTI
- Patients with ileal loops or urinary stoma
- Patients with an indwelling urinary catheter in the previous 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofloxacinAlso: CiproCiprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI. | Drug | Ciprofloxacin |
Primary outcome
Number of Subjects With Combined Clinical and Microbiologic Response
Time frame: From start of treatment until assessment of cure, approximately 12 days
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
1 secondary outcome
Microbiologic Response
Time frame: From start of treatment until assessment of cure, approximately 12 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Aronin, MD principal investigator
Iterum Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofloxacin in people with UTI - Lower Urinary Tract Infection and Antibiotic Resistant Infection, run by Iterum Therapeutics, International Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Combined Clinical and Microbiologic Response (time frame: From start of treatment until assessment of cure, approximately 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.