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

INTERVENTION: 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 Concentration number: 1‐ Pharmaceutical Form: Tablet INN or Proposed INN: ‐ CAS Number: ‐ Current Sponsor code: ‐ Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE HYDRATE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 250‐750 Pharmaceutical Form: Tablet INN or Proposed INN: ‐ CAS Number: 8064‐90‐2 Current Sponsor code: ‐ Other descriptive name: CO‐TRIMOXAZOLE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 400‐800 Pharmaceutical Form: Tablet INN or Proposed INN: ‐ CAS Number: 55268‐75‐2 Current Sponsor code: ‐ Other descriptive name: CEFUROXIME Concentration unit: mg milligram(s) Concentration type: range Concentration number: 250‐500 Pharmaceutical Form: Tablet INN or Proposed INN: CLAVULANIC ACID CAS Number: 58001‐44‐8 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 62.5‐200 INN or Proposed INN: AMOXICILLIN CAS Number: 26787‐78‐0 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 500‐2000 CONDITION: 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 Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: Establish if receiving antibiotic treatment for asyntomatic bacteriuria is usefull to prevent acute allograft pyelonephritis in renal transplant recipients Primary end point(s): Number of patients developing acute pyelonephritis in each group of treatment 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 Timepoint(s) of evaluation of this end point: at 12 months SECONDARY OUTCOME: 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 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