E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021872 |
E.1.2 | Term | Infection urinary tract |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The final statistical analysis thinks about as an analysis of survival where the appearance of the event (urinary infection) it motivates the finalization of the period of pursuit. The curves of Kaplan-Meier of the experimental intervention and that of the standard treatment are valued. It will be valued the reason of incidence and their confidence interval to 95% of the experimental interventions with a regression of proportional risks of Cox. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |