Asymptomatic BacteriuriaBAC01NCT01771432
Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria
A study testing Antibiotic treatment and No treatment in people with Asymptomatic Bacteriuria and Pyelonephritis, run by Núria Sabé Fernàndez at 2 sites in Spain.
Trial summary
Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Asymptomatic Bacteriuria, Pyelonephritis
- What is being tested?
- Antibiotic treatment and No treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2013to Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who receive a transplant allograft during study period
Who cannot join
- No acceptation of study
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona, Barcelona
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Núria Sabé Fernàndez, +34932607625, nfsabe@bellvitgehsopital.cat
About this study
Official title: Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.
Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients.
Read the detailed description
Design: Randomized prospective study. Setting: University Hospital with an active kidney transplantation program. Patients: Adult kidney transplant recipients. Interventions: Kidney transplant recipients with asymptomatic bacteriuria will be randomly assigned to be treated with antibiotics or to be followed without antibiotic therapy.
Measurements: Urine cultures will be collected weekly during the first month after transplantation, every 2 weeks until three months after transplantation, every month until 6 months after transplantation and every 3 months until 12 months after transplantation. Urine culture will be as well collected if urinary symptoms appeared.
Primary end points: To determine in both groups: the incidence of pyelonephritis.
Secondary end points: To determine outcomes in both groups (renal function, hospitalization, rejection, graft loss, opportunistic infections and mortality) and infection by multiresistant microorganisms.
- Conditions
- Asymptomatic Bacteriuria, Pyelonephritis
- Being tested
- Antibiotic treatment, No treatment
- Medical subject headings
- Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic treatmentDrug
Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics
No treatmentOther
Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic treatment | Active comparator | Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics. Receives: Drug: Antibiotic treatment |
| No treatment | Other | Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of pyelonephritis in both groups
Measured: First year after kidney transplantation
Secondary outcomes (4)
Renal function
Measured: First year after kydney transplantation
Need for hospitalization
Measured: First year after kydney transplantation
Incidence of graft loss
Measured: First year after kidney transplantation
Mortality
Measured: First year after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Núria Sabé Fernàndez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Núria Sabé Fernàndez, Hospital Universitari de Bellvitge
- Investigators
- Núria Sabé Fernàndez, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771432
- Sponsor's protocol ID
- FIS11-1540
- Acronym
- BAC01
- Status last verified
- Jun 2015
- First submitted
- 21 Dec 2012
- Last updated
- 22 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT01771432
- Acronym / sponsor ID
- BAC01 / FIS11-1540
- Conditions
- Asymptomatic Bacteriuria, Pyelonephritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Núria Sabé FernàndezUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 Jan 2013 (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.
Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients.
Detailed description
Design: Randomized prospective study. Setting: University Hospital with an active kidney transplantation program. Patients: Adult kidney transplant recipients. Interventions: Kidney transplant recipients with asymptomatic bacteriuria will be randomly assigned to be treated with antibiotics or to be followed without antibiotic therapy.
Measurements: Urine cultures will be collected weekly during the first month after transplantation, every 2 weeks until three months after transplantation, every month until 6 months after transplantation and every 3 months until 12 months after transplantation. Urine culture will be as well collected if urinary symptoms appeared.
Primary end points: To determine in both groups: the incidence of pyelonephritis.
Secondary end points: To determine outcomes in both groups (renal function, hospitalization, rejection, graft loss, opportunistic infections and mortality) and infection by multiresistant microorganisms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic treatment | Active comparator | Drug: Antibiotic treatmentKidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics. |
| No treatment | Other | Other: No treatmentKidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who receive a transplant allograft during study period
Key exclusion criteria (1 listed)
- No acceptation of study
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 treatmentKidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics | Drug | Antibiotic treatment |
| No treatmentKidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy | Other | No treatment |
Primary outcome
To determine the incidence of pyelonephritis in both groups
Time frame: First year after kidney transplantation
4 secondary outcomes
Renal function
Time frame: First year after kydney transplantation
Need for hospitalization
Time frame: First year after kydney transplantation
Incidence of graft loss
Time frame: First year after kidney transplantation
Mortality
Time frame: First year after kidney transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
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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.
Núria Sabé Fernàndez principal investigator
Hospital Universitari de Bellvitge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic treatment and No treatment in people with Asymptomatic Bacteriuria and Pyelonephritis, run by Núria Sabé Fernàndez at 2 sites in Spain.
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 1 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 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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.
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?
Contact Núria Sabé Fernàndez (+932607625, nfsabe@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the incidence of pyelonephritis in both groups (time frame: First year after kidney transplantation). 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 22 Jun 2015.