Urinary Tract InfectionsPhase 4INSTANTNCT03299387
INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI
A Phase 4 study testing Nitrofurantoin and Gentamicin in people with Urinary Tract Infections, run by Mayo Clinic.
Trial summary
Women have problems with oral antibiotics, including vagina and bowel infections. Also, bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement of antibiotic directly into the bladder does not cause these problems and are at doses that are may be able to stop bacteria from being… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Nitrofurantoin and Gentamicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2017to 5 Jul 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Ability to understand study procedures and to comply with them for the entire length of the study.
Who cannot join
- Patients who report that they are pregnant.
- Patients with a positive urine pregnancy test
- Patients with a history of renal transplantation.
- Patients with bladder augmentation procedures using bowel.
- Patients with poorly controlled Type II diabetes, Hgb A1C >6.5%
- Patients with spinal cord injury, ASIA Impairment Scale of C or higher.
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- Patients with pelvic surgery within 6 months.
- Patients with urologic procedure within 6 months.
- Patients with a history of reconstructive urologic surgery, such as reflux, congenital abnormality.
- Immunocompromised patients being treated for malignancy or a history of actively treated malignancy within 5 years.
- Patients with active systemic autoimmune disease.
- Patients on systemic immunosuppression.
- Use of antibiotic prophylaxis within 6 months
- Use of antibiotics within 10 days of active infection
- Allergy/sensitivity to gentamicin or nitrofurantoin.
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of individual to give written informed consent.
About this study
Official title: INtravesical Antimicrobial Agents Versus STANDard Oral Antibiotics for the Treatment of Acute Urinary Tract Infection in Women With Recurrent Urinary Tract Infection (INSTANT Study)
Women have problems with oral antibiotics, including vagina and bowel infections. Also, bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement of antibiotic directly into the bladder does not cause these problems and are at doses that are may be able to stop bacteria from being resistant to antibiotics.
Read the detailed description
Each participant once enrolled returns with an active Urinary Tract Infection (UTI), confirmed by urine void. Participants will complete an UTI questionnaire, and if consistent with a simple non-febrile UTI will be randomized to one of two arms: oral nitrofurantoin treatment for 7 days, or intravesical gentamicin instillation once a day for three days. Patients will be followed for symptom relief with a repeat voided urine in 7 to 10 days, and with a repeated questionnaire for symptom relief.
- Conditions
- Urinary Tract Infections
- Being tested
- Nitrofurantoin, Gentamicin
- Keywords
- urinary tract, infection, recurrent, women
- Medical subject headings
- Urinary Tract Infections, Infections, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitrofurantoinDrug
Also called Macrobid, Furadantin, Macrodantin
Participants will receive oral Nitrofurantoin 100 mg twice daily for 7 days
GentamicinDrug
Also called Gentak, Garamycin
Participants will receive intravesical via catheter Gentamicin solution 25 mg in 50cc for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Oral Nitrofurantoin | Active comparator | Participants will randomized to oral nitrofurantoin Receives: Drug: Nitrofurantoin |
| Intravesical Gentamicin | Active comparator | Participants will be randomized to intravesical gentamicin Receives: Drug: Gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiologic effect of a chronic acute Urinary Tract Infection
Microbiological culture growth of susceptible organisms obtained on day 0, compared with voided urine culture as no growth in 24-48 hours obtained at 7-10 days
Measured: baseline, 7-10 days
Change in symptomatic relief of a chronic acute Urinary Tract Infection
Completion of a Symptom Urinary Tract Questionnaire. Tracking the symptoms in the past 24 hours. Indicating how severe and how bothersome they were. Severe ranging from 0 (Did not have) to 3 (Severe). Bothersome ranging from 0 (Not at all) to 3 (A lot)
Measured: baseline, 7-10 days
Secondary outcomes (1)
To establish the clinical FTE needs for providing urgent intravesical treatments
Nursing needs to provide intravesical treatments of acute Urinary Tract Infections (UTI) in women with chronic recurrent UTIs. Measured in amount of participants and FTE requirement for nursing staff.
Measured: baseline, through stufy completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start28 Jun 2017
- Primary completion5 Jul 2018
- Study completion5 Jul 2018
Why it stopped: Study never recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah J. Lightner, Mayo Clinic
- Investigators
- Deborah Lightner, MD, Principal investigator, Mayo ClinicAudrey N Schuetz, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299387
- Sponsor's protocol ID
- 11-002887
- Acronym
- INSTANT
- Status last verified
- Jun 2019
- First submitted
- 20 Sep 2017
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtravesical Antimicrobial Agents Versus STANDard Oral Antibiotics for the Treatment of Acute Urinary Tract Infection in Women With Recurrent Urinary Tract Infection (INSTANT Study)
- ClinicalTrials.gov ID
- NCT03299387
- Acronym / sponsor ID
- INSTANT / 11-002887
- Conditions
- Urinary Tract Infections
- Keywords
- urinary tract, infection, recurrent, women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women have problems with oral antibiotics, including vagina and bowel infections. Also, bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement of antibiotic directly into the bladder does not cause these problems and are at doses that are may be able to stop bacteria from being resistant to antibiotics.
Detailed description
Each participant once enrolled returns with an active Urinary Tract Infection (UTI), confirmed by urine void. Participants will complete an UTI questionnaire, and if consistent with a simple non-febrile UTI will be randomized to one of two arms: oral nitrofurantoin treatment for 7 days, or intravesical gentamicin instillation once a day for three days. Patients will be followed for symptom relief with a repeat voided urine in 7 to 10 days, and with a repeated questionnaire for symptom relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Nitrofurantoin | Active comparator | Drug: NitrofurantoinParticipants will randomized to oral nitrofurantoin |
| Intravesical Gentamicin | Active comparator | Drug: GentamicinParticipants will be randomized to intravesical gentamicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ability to understand study procedures and to comply with them for the entire length of the study.
Key exclusion criteria (17 listed)
- Patients who report that they are pregnant.
- Patients with a positive urine pregnancy test
- Patients with a history of renal transplantation.
- Patients with bladder augmentation procedures using bowel.
- Patients with poorly controlled Type II diabetes, Hgb A1C >6.5%
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 |
|---|---|---|
| NitrofurantoinAlso: Macrobid, Furadantin, MacrodantinParticipants will receive oral Nitrofurantoin 100 mg twice daily for 7 days | Drug | Oral Nitrofurantoin |
| GentamicinAlso: Gentak, GaramycinParticipants will receive intravesical via catheter Gentamicin solution 25 mg in 50cc for 3 days | Drug | Intravesical Gentamicin |
Primary outcome
Change in microbiologic effect of a chronic acute Urinary Tract Infection
Time frame: baseline, 7-10 days
Microbiological culture growth of susceptible organisms obtained on day 0, compared with voided urine culture as no growth in 24-48 hours obtained at 7-10 days
Change in symptomatic relief of a chronic acute Urinary Tract Infection
Time frame: baseline, 7-10 days
Completion of a Symptom Urinary Tract Questionnaire. Tracking the symptoms in the past 24 hours. Indicating how severe and how bothersome they were. Severe ranging from 0 (Did not have) to 3 (Severe). Bothersome ranging from 0 (Not at all) to 3 (A lot)
1 secondary outcome
To establish the clinical FTE needs for providing urgent intravesical treatments
Time frame: baseline, through stufy completion, an average of one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Deborah Lightner, MD principal investigator
Mayo Clinic
Audrey N Schuetz, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitrofurantoin and Gentamicin in people with Urinary Tract Infections, run by Mayo Clinic.
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 1 inclusion and 17 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: withdrawn, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in microbiologic effect of a chronic acute Urinary Tract Infection (time frame: baseline, 7-10 days). The study lists 2 primary outcomes in all. 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 Jun 2019.