An interventional study of Antibiotic treatment and No treatment in Asymptomatic Bacteriuria and Pyelonephritis, sponsored by Núria Sabé Fernàndez. Status unknown at 2 sites in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-06-22.
Sponsored by Núria Sabé Fernàndez · Not applicable, Interventional, and Prevention
Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients.
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.
79 studies on the registry are indexed under Pyelonephritis; 12 are open to participants now.
This study's planned enrollment of 200 is above the median of 175 across 62 interventional studies indexed under Pyelonephritis.
Browse Pyelonephritis studies →This is the only study on the registry with Núria Sabé Fernàndez as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics.
Drug: Antibiotic treatment
Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
Other: No treatment
Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics
Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
To determine the incidence of pyelonephritis in both groups
Time frame: First year after kidney transplantation
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
Infection by multiresistant microorganisms
Time frame: First year after kydney transplantation
The record gives a start of Jan 2013, a primary completion of Sep 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.