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Febrile urinary tract infections (UTIs) are common in children, but there is no consensus concerning the duration of the antibiotic treatment. Current recommendations include the use of an oral antibiotic, chosen between amoxicillin and clavulanic acid or a third-generation cephalosporin (ceftibuten), for a minimum of seven to a maximum of 14 days. In an antibiotic overuse-sparing model, proper evaluation of a shorter therapy in the treatment of febrile UTI in childhood is lacking.
The objective of this randomized controlled trial is to assess the non inferiority of a five days oral course of amoxicillin and clavulanic acid vs the standard 10-day regimen in the treatment of febrile UTIs in children.
The trial results might provide evidence of the non-inferiority of a short duration of the antibiotic course for the treatment of febrile UTI in childhood, contributing to a reduction in the over-use of antibiotics and consequently limiting the emergence of antibiotic resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short treatment group | Experimental | Amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 5 consecutive days |
|
| Standard treatment group | Active Comparator | amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 10 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin and Clavulanic Acid in Oral Dose Form | Drug | 50 mg/kg three times daily administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of infection recurrence | Infection recurrence rate is defined as the reappearance of signs and symptoms of febrile UTI by the first day after the end of antibiotic therapy | within 30 days after the end of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete resolution of signs and symptoms | The complete resolution of the signs and symptoms (clinical assessment and urinalysis) related to the infection evaluated at the end of the treatment, without the need for additional or alternative antibiotic therapy (short term clinical efficacy) | within 30 days after the end of the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Egidio Barbi, MD Prof | Institute for maternal and child health Burlo Garofolo | Study Chair |
| Marco Pennesi, MD | Institute for maternal and child health Burlo Garofolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico S.Orsola-Malpighi | Bologna | Emilia-Romagna | 40138 | Italy | ||
| Santa Maria delle Croci Hospital |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D019818 | Clavulanic Acid |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Rate of antibiotic-resistant or of opportunistic strains in relapses | Antibiotic resistance is defined as the presence of positive urinalysis and positive urine culture for a single type of bacterium resistant to amoxicillin and clavulanic acid, after treatment in case of relapse. The bacterial growth will be considered significant if >105 colony-forming unit/ml (CFU/ml) (>104 CFU/ml for urine samples collected by bladder catheterization). Urine cultures containing more than one bacterial species will be considered contaminated. | within 30 days after the end of the intervention |
| Ravenna |
| Emilia-Romagna |
| 48121 |
| Italy |
| Ospedale San Polo | Monfalcone | Friuli Venezia Giulia | 34074 | Italy |
| Pediatric Department, Santa Maria degli Angeli Hospital | Pordenone | Friuli Venezia Giulia | 33170 | Italy |
| Institute for Maternal and Child Health IRCCS Burlo Garofolo | Trieste | Friuli Venezia Giulia | 34137 | Italy |
| ASUIUD Azienda sanitaria universitaria integrata di Udine | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Fondazione Policlinico Agostino Gemelli - IRCCS City Rome | Rome | Lazio | 00168 | Italy |
| Fondazione IRCSS Ca Granda, Policlinico di Milano | Milan | Lombardy | 20122 | Italy |
| A.O.U.G. Martino | Messina | Sicily | 98124 | Italy |
| Ospedali Riuniti di Ancona - Ospedale Salesi | Ancona | The Marches | 60123 | Italy |
| San Martino Hospital | Belluno | Veneto | 32100 | Italy |
| Department of Woman and Child Health, University of Padua City | Padua | Veneto | 35128 | Italy |
| UOC Pediatria Ospedale Ca' Foncello | Treviso | Veneto | 31100 | Italy |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002969 | Clavulanic Acids |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |