Clinical trial comparing antibiotic treatment to observation in renal transplant patients with asimptomatic urinary tract infection

Randomized, prospective trial comparing antibiotic treatment to observation in renal transplant patients with asimptomatic bacteriuria - BAC01

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001716-30-ES

Enrollment

Unknown

Registered

2012-06-12

Start date

2012-09-27

Completion date

Unknown

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asyntomatic bacteriuria an acute pyelonephritis in renal transplant patients MedDRA version: 14.1 Level: PT Classification code 10056396 Term: Asymptomatic bacteriuria System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10001032 Term: Acute pyelonephritis System Organ Class: 10021881 - Infections and infestations

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: - CAS Number: - Current Sponsor code: - Other descriptive name: AMOXICILLIN SODIUM Concentration unit: mg milligram(s) Concentration type: equal Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients receiving a renal tranplant in the Hospital Universitari de Bellvitge. Informed consent Form signed and dated by patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Refusal to give writen informed consent. any other reason that investigator considers that would interfere in the correct participation of the patient in this trial

Design outcomes

Primary

Measure	Time frame
Main Objective: Establish if receiving antibiotic treatment for asyntomatic bacteriuria is usefull to prevent acute allograft pyelonephritis in renal transplant recipients;Secondary Objective: Evaluation of renal function of renal transplant patients during the study period. Determination of the number of patients developing bacteriemia during the episode of pyelonephritis Determination of the percentage of patients requiring admission due to any cause during the study period Determination of the percentage of patients presenting acute rejection, graft loss, opportunistic infections, infections due to multi-resistant bacteria and mortality rate during the study period. Comparison of the clinical outcome of renal transplant patients developing asyntomatic bacteriuria versus those patients not presenting this complication Establish the risk factors assiciated with the development of asyntomatic bacteriuria in renal transplant patients;Primary end point(s): Number of patients developing acute pyelonephritis in each group of treatment;Timepoint(s) of evaluation of this end point: at 12 months	—

Measure

Time frame

Main Objective: Establish if receiving antibiotic treatment for asyntomatic bacteriuria is usefull to prevent acute allograft pyelonephritis in renal transplant recipients;Secondary Objective: Evaluation of renal function of renal transplant patients during the study period. Determination of the number of patients developing bacteriemia during the episode of pyelonephritis Determination of the percentage of patients requiring admission due to any cause during the study period Determination of the percentage of patients presenting acute rejection, graft loss, opportunistic infections, infections due to multi-resistant bacteria and mortality rate during the study period. Comparison of the clinical outcome of renal transplant patients developing asyntomatic bacteriuria versus those patients not presenting this complication Establish the risk factors assiciated with the development of asyntomatic bacteriuria in renal transplant patients;Primary end point(s): Number of patients developing acute pyelonephritis in each group of treatment;Timepoint(s) of evaluation of this end point: at 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): Renal function of renal transplant patients during the study period Number of patients developing bacteriemia during the episode of pyelonephritis Percentage of patients requiring admission due to any cause during the study period Percentage of patients presenting acute rejection, graft loss, opportunistic infections, infections due to multi-resistant bacteria and mortality rate during the study period. Clinical outcome of renal transplant patients developing asyntomatic bacteriuria versus those patients not presenting this complication Risk factors assiciated with the development of asyntomatic bacteriuria in renal transplant patients;Timepoint(s) of evaluation of this end point: at 12 months	—

Measure

Time frame

Secondary end point(s): Renal function of renal transplant patients during the study period Number of patients developing bacteriemia during the episode of pyelonephritis Percentage of patients requiring admission due to any cause during the study period Percentage of patients presenting acute rejection, graft loss, opportunistic infections, infections due to multi-resistant bacteria and mortality rate during the study period. Clinical outcome of renal transplant patients developing asyntomatic bacteriuria versus those patients not presenting this complication Risk factors assiciated with the development of asyntomatic bacteriuria in renal transplant patients;Timepoint(s) of evaluation of this end point: at 12 months

—

Countries

Spain

Contacts

Public ContactInfectious Diseases Department

Hospital Universitari de Bellvitge

cpolo@idibell.cat+34932607385

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026