First clinical assay so far where the convenience is evaluated of carrying out prophylaxis of the pediatric urinary recurrent infection in the childhood with extract of cranberries (with a fixed content in proantocianidins) in front of the conventional prevention with Trimethoprim. MedDRA version: 9.1 Level: LLT Classification code 10021872 Term: Infection urinary tract
Conditions
Interventions
Trade Name: URELL-CRANBERRY SOL. 150 ML
Product Name: URELL CRANBERRY
Product Code: CN 314264.9
Pharmaceutical Form: Oral solution
INN or Proposed INN: Proantocianidinas tipo A
CAS Number: PAC
Concen
Sponsors
Servicio Andaluz de Salud
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children of 3 months to 5 years of age that consult for anyone of the points 2, 3 and 4 of this section, in anyone of the consultations of specialized Attention of the Virgen de las Nieves (Granada), Clinical San Cecilio of Granada and Regional Hospitals of Baza and Motril. 2. But of an urine infection confirmed by cultive (>100.000 UFC/ml) and I urine analysis with but of 20 leukocytes for field, in a sample of urine collection to the watching or with bag urine colector or catheter, previous asepsis with chlrohexidin. 3. Existence of urine reflux in any grade confirmed by cystography or dilation of the renal pelvis or the road urinaria confirmed by ecography. 4. Existence of any anatomical anomaly of the road urinaria that could justify continuous prevention with antibiotics in the current protocols of performance. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Coexistence of other infectious illnesses. 2. Coexistence of metabolic illnesses. 3. Renal failure. 4. Liver failure. 5. Allergy existence or intolerance to some of the components of the cranberry juice or Trimetoprim. 6. Existence of sanguine diseases. 7. I want legal representant of not participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: We thinks about as secondary objective of the present study to identify the bacterial flora isolated in the urinary infections detected during the prevention with cranberry juice and with Trimetoprim, to analyze the etiologic differences and their different resistance to the election antibiotics for their treatment.;Primary end point(s): We think that the Cranberry syrup use like inhibitors of the bacterial adhesion to the uroepithelium can be an useful alternative to the antibiotic prevention in the urinary recurrent infection, aspect that would improve the growing bacterial resistance to the antibiotics. ;Main Objective: The general objective of the present study is to check if the extract of red cranberry juice is effective in the prevention of the urinary recurrent infection. We know for previous studies that the antibiotic prevention can modify the type and the bacterial resistances to antibiotics of the microorganisms isolated in urinary recurrent infection. | — |
Countries
Spain
Outcome results
None listed