Asymptomatic BacteriuriaNCT02373085
Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.
A study testing Antibiotic adjusted to antibiogram in people with Asymptomatic Bacteriuria, run by López-Medrano, Francisco, M.D..
Trial summary
Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asymptomatic Bacteriuria
- What is being tested?
- Antibiotic adjusted to antibiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients developing asymptomatic bacteriuria beyond 2 months after transplantation.
Who cannot join
- <18 years old
- Pregnant women
- Kidney-pancreas transplantation
- Double J stent catheterization at the momento of randomization
- Permanent vesical catheter
About this study
Official title: Effect of Systematic Search and Antimicrobial Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients in the Incidence of Acute Pyelonephritis: a Pragmatic Prospective Randomized Controlled Study.
Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial treatment of all episodes of AB.
Read the detailed description
All patients undergoing KT between January 2011 and December 2013 in a tertiary-care center with an active transplantation program were systematically searched for AB within the first 2 years after transplantation on a regular basis. During the first 2 months after transplantation all episodes of AB were treated. Thereafter, patients were assigned, according to a computer-generated randomization sequence, to group A (systematic antimicrobial treatment of all episodes of AB) or group B (no treatment). Treatment was chosen according to the results of the urine culture.
- Conditions
- Asymptomatic Bacteriuria
- Being tested
- Antibiotic adjusted to antibiogram
- Keywords
- Asymptomatic Bacteriuria, Kidney transplant recipients, Pyelonephritis
- Medical subject headings
- Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic adjusted to antibiogramOther
Also called Anti-infective agents
A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria during the first 2 years after transplantation.
| Study group | Role | What they receive |
|---|---|---|
| A: Antibiotic adjusted to antibiogram | Experimental | A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria beyond 2 months after transplantation and during the first 2 years after transplantation Receives: Other: Antibiotic adjusted to antibiogram |
| B: no treatment | No intervention | No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pyelonephritis
The number of patients that develope pyelonephritis in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
Measured: 2 years after transplantation
Secondary outcomes (4)
Incidence of lower tract urinary infection
The number of patients that develope lower tract urinary infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
Measured: 2 years after transplantation
Incidence of Clostridium difficile infection
The number of patients that develope Clostridium difficile infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
Measured: 2 years after transplantation
Incidence of multidrug resistant bacteria colonization/infection
The number of patients that develope multidrug resistant bacteria colonization/infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
Measured: 2 years after transplantation
Long-term graft function
Long-term graft function measured by average serum creatinine at several points until the end of follow-up.
Measured: At 1 year and 2 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJan 2011
- Primary completionAug 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic BacteriuriaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- López-Medrano, Francisco, M.D.
- Responsible party
- Principal investigator, Francisco López Medrano, López-Medrano, Francisco, M.D.
- Investigators
- Francisco López-Medrano, MD,PhD, Principal investigator, López-Medrano, Francisco, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373085
- Sponsor's protocol ID
- ABTxR-H12O
- Status last verified
- Feb 2015
- First submitted
- 13 Feb 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Origuen J, Lopez-Medrano F, Fernandez-Ruiz M, Polanco N, Gutierrez E, Gonzalez E, Merida E, Ruiz-Merlo T, Morales-Cartagena A, Perez-Jacoiste Asin MA, Garcia-Reyne A, San Juan R, Orellana MA, Andres A, Aguado JM. Should Asymptomatic Bacteriuria Be Systematically Treated in Kidney Transplant Recipients? Results From a Randomized Controlled Trial. Am J Transplant. 2016 Oct;16(10):2943-2953. doi: 10.1111/ajt.13829. Epub 2016 May 23.
PubMed 27088545
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systematic Search and Antimicrobial Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients in the Incidence of Acute Pyelonephritis: a Pragmatic Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT02373085
- Acronym / sponsor ID
- ABTxR-H12O
- Conditions
- Asymptomatic Bacteriuria
- Keywords
- Asymptomatic Bacteriuria, Kidney transplant recipients, Pyelonephritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- López-Medrano, Francisco, M.D.
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Feb 2015 (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.
Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial treatment of all episodes of AB.
Detailed description
All patients undergoing KT between January 2011 and December 2013 in a tertiary-care center with an active transplantation program were systematically searched for AB within the first 2 years after transplantation on a regular basis. During the first 2 months after transplantation all episodes of AB were treated. Thereafter, patients were assigned, according to a computer-generated randomization sequence, to group A (systematic antimicrobial treatment of all episodes of AB) or group B (no treatment). Treatment was chosen according to the results of the urine culture.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Antibiotic adjusted to antibiogram | Experimental | Other: Antibiotic adjusted to antibiogramA course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria beyond 2 months after transplantation and during the first 2 years after transplantation |
| B: no treatment | No intervention | –No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients developing asymptomatic bacteriuria beyond 2 months after transplantation.
Key exclusion criteria (5 listed)
- <18 years old
- Pregnant women
- Kidney-pancreas transplantation
- Double J stent catheterization at the momento of randomization
- Permanent vesical catheter
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 |
|---|---|---|
| Antibiotic adjusted to antibiogramAlso: Anti-infective agentsA course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria during the first 2 years after transplantation. | Other | A: Antibiotic adjusted to antibiogram |
Primary outcome
Incidence of Pyelonephritis
Time frame: 2 years after transplantation
The number of patients that develope pyelonephritis in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
4 secondary outcomes
Incidence of lower tract urinary infection
Time frame: 2 years after transplantation
Incidence of Clostridium difficile infection
Time frame: 2 years after transplantation
Incidence of multidrug resistant bacteria colonization/infection
Time frame: 2 years after transplantation
Long-term graft function
Time frame: At 1 year and 2 years after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
- Derived from this study: PubMed 27088545Origuen J, Lopez-Medrano F, Fernandez-Ruiz M, Polanco N, Gutierrez E, Gonzalez E, Merida E, Ruiz-Merlo T, Morales-Cartagena A, Perez-Jacoiste Asin MA, Garcia-Reyne A, San Juan R, Orellana MA, Andres A, Aguado JM. Should Asymptomatic Bacteriuria Be Systematically Treated in Kidney Transplant Recipients? Results From a Randomized Controlled Trial. Am J Transplant. 2016 Oct;16(10):2943-2953. doi: 10.1111/ajt.13829. Epub 2016 May 23.
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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.
Francisco López-Medrano, MD,PhD principal investigator
López-Medrano, Francisco, M.D.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic adjusted to antibiogram in people with Asymptomatic Bacteriuria, run by López-Medrano, Francisco, M.D..
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 5 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 26 Feb 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Pyelonephritis (time frame: 2 years after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02373085, which also lists 1 linked publication.
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 26 Feb 2015.