Urinary Tract InfectionPhase 4NCT02113774
The Impact of Antimicrobial Treatment for Asymptomatic Bacteriuria in Renal Transplant Patients
A Phase 4 study testing antimicrobial treatment according to in-vitro susceptibility in people with Urinary Tract Infection and Bacteriuria, run by Rabin Medical Center.
Trial summary
The investigators hypothesize that antibiotic therapy for asymptomatic bacteriuria in renal transplant patients does not have impact on the development of symptomatic urinary tract infection (UTI) or progression of renal impairment in patients during the first year after transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection, Bacteriuria, Renal Transplantation
- What is being tested?
- antimicrobial treatment according to in-vitro susceptibility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2014to Apr 2019
- 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
- All sexes
- Adult, Older adult
Who may be able to join
- Patients who are ≥1 month and ≤ 12 months after renal transplantation.
- Positive urine culture defined as ≥ 105 colony forming units (CFU) per milliliter of a known single pathogen.
Who cannot join
- Any one of the following signs and symptoms: fever, abdominal pain, dysuria, frequency, urgency, flank pain, costovertebral-angel tenderness or tenderness over the transplanted kidney
- Active infections in another site
- Leucocytosis (WBC >18.000K/micl) or leucopenia (WBC < 3.000 K/micl)
- Elevation of serum creatinine of more than 15% of its baseline level
- Obstructive or other urological complications following transplantation as known foreign device (stent/double-J-Cath, any catheter) in the urinary tract system, known obstruction of the transplanted kidney, indwelling or intermittent catheterization
- Pregnant or lactating women.
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- Candidates to invasive urologic procedures.
- Inability to return for regular follow up.
- Previous enrollment in this study.
- Patients who incapable of giving informed consent.
About this study
The investigators hypothesize that antibiotic therapy for asymptomatic bacteriuria in renal transplant patients does not have impact on the development of symptomatic urinary tract infection (UTI) or progression of renal impairment in patients during the first year after transplantation.
- Conditions
- Urinary Tract Infection, Bacteriuria, Renal Transplantation
- Being tested
- antimicrobial treatment according to in-vitro susceptibility
- Medical subject headings
- Urinary Tract Infections, Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antimicrobial treatment according to in-vitro susceptibilityOther
| Study group | Role | What they receive |
|---|---|---|
| no therapy | No intervention | Not described |
| antimicrobial treatment according to in-vitro susceptibility | Active comparator | Not described Receives: Other: antimicrobial treatment according to in-vitro susceptibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of symptomatic urinary tract infection
Measured: 30 days
Secondary outcomes (1)
25% reduction in estimated glomerular filtration rate (eGFR)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Rahamimov, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113774
- Sponsor's protocol ID
- 7687
- Status last verified
- Apr 2014
- First submitted
- 23 Mar 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Antimicrobial Treatment for Asymptomatic Bacteriuria in Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT02113774
- Acronym / sponsor ID
- 7687
- Conditions
- Urinary Tract Infection, Bacteriuria, Renal Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2019 (estimated)
- First posted
- 15 Apr 2014 (estimated)
- 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.
The investigators hypothesize that antibiotic therapy for asymptomatic bacteriuria in renal transplant patients does not have impact on the development of symptomatic urinary tract infection (UTI) or progression of renal impairment in patients during the first year after transplantation.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no therapy | No intervention | – |
| antimicrobial treatment according to in-vitro susceptibility | Active comparator | Other: antimicrobial treatment according to in-vitro susceptibility |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are ≥1 month and ≤ 12 months after renal transplantation.
- Positive urine culture defined as ≥ 105 colony forming units (CFU) per milliliter of a known single pathogen.
Key exclusion criteria (10 listed)
- Any one of the following signs and symptoms: fever, abdominal pain, dysuria, frequency, urgency, flank pain, costovertebral-angel tenderness or tenderness over the transplanted kidney
- Active infections in another site
- Leucocytosis (WBC >18.000K/micl) or leucopenia (WBC < 3.000 K/micl)
- Elevation of serum creatinine of more than 15% of its baseline level
- Obstructive or other urological complications following transplantation as known foreign device (stent/double-J-Cath, any catheter) in the urinary tract system, known obstruction of the transplanted kidney, indwelling or intermittent catheterization
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 |
|---|---|---|
| antimicrobial treatment according to in-vitro susceptibility | Other | antimicrobial treatment according to in-vitro susceptibility |
Primary outcome
development of symptomatic urinary tract infection
Time frame: 30 days
1 secondary outcome
25% reduction in estimated glomerular filtration rate (eGFR)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing antimicrobial treatment according to in-vitro susceptibility in people with Urinary Tract Infection and Bacteriuria, run by Rabin Medical Center.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Apr 2014. 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?
Results are not available in the source record.
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?
development of symptomatic urinary tract infection (time frame: 30 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 15 Apr 2014.