A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux
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| ClinicalTrials.gov Identifier: NCT00382343 |
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Recruitment Status :
Completed
First Posted : September 29, 2006
Last Update Posted : April 28, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pyelonephritis Renal Scars | Drug: Sulfamethoxazole/trimethoprim | Phase 4 |
In recent years, the effectiveness of continuous antibiotic prophylaxis in children with vesico-ureteral reflux (VUR) has been intensely discussed. The question is not only whether antibiotics are effective in preventing recurrent urinary tract infections (UTI), but also whether they alter the natural history of disease and help to prevent the appearance of new kidneys scars. The evidence on the effectiveness of antibiotic prophylaxis is scanty: randomised controlled trials (RCT) published until now are poorly designed and carried out in very heterogeneous samples of children, i.e. spanning from 6 months to 14-18 years of age and pooling patients with and without VUR. A recently updated Cochrane Systematic Review concludes that high quality RCTs are needed to determine the effectiveness of long-term antibiotics for the prevention of UTIs in susceptible children. Moreover, the presence of VUR has not been firmly shown to be a risk factor for recurrence of pyelonephritis, and a direct association between VUR and the presence of scars or the appearance of new scars has not been demonstrated; there is just an association between VUR of grade IV-V and prenatal renal dysplasia, almost exclusively in male infants. In spite of this uncertainty, several practice guidelines recommend long term antibiotic prophylaxis in children with different degrees of VUR.
The aim of this study is to assess the effectiveness of antibiotic prophylaxis in preventing pyelonephritis and in avoiding the appearance of new scars in a sample of children under 36 months with VUR.
Comparison: In a multicentre trial, 100 patients with VUR diagnosed with cystourethrography after a first episode of acute pyelonephritis or for prenatal evidence of pyelectasia will be assigned randomly to receive prophylaxis or not. Randomization will be carried out using a centralized minimization procedure to balance for sex, age group and VUR grade.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 96 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Antibiotic Prophylaxis After Acute Pyelonephritis for Prevention of Urinary Tract Infections in Children With Vesico-Ureteral Reflux. |
| Study Start Date : | November 1999 |
| Actual Primary Completion Date : | March 2003 |
| Actual Study Completion Date : | March 2007 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: sulfamethoxazole/trimethoprim
Antibiotic prophylaxis with sulfamethoxazole/trimethoprim [1-2 mg/kg trimethoprim and 5-10 mg/kg sulfamethoxazole once daily]; in case of intolerance (leucopoenia) and for children younger than 6 months: nitrofurantoin [2 mg/kg once daily]
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Drug: Sulfamethoxazole/trimethoprim
Sulfamethoxazole/trimethoprim prophylaxis |
| No Intervention: No prophylaxis |
- Recurrence of pyelonephritis [ Time Frame: up to 4 years after enrollment ]Urinalysis and urine culture performed at each episode of fever or when symptoms of UTI occurred (eg, change in the smell of urine, anorexia, irritability)
- Renal scars [ Time Frame: 4 years after enrollment ]DMSA renal scan
- Persistence of vesico-ureteral reflux [ Time Frame: 4 years after enrollment ]Cystourethrography and renal ultrasound
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| Ages Eligible for Study: | up to 30 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- presence of vesico-ureteral reflux (VUR) grade II, III or IV, based on the International Classification, mono or bilateral, diagnosed between one day and 30 months of age after a first episode of acute pyelonephritis, or after birth during diagnostic procedures planned as a consequence of prenatal ultrasonographic evidence of pyelectasia.
Exclusion Criteria:
- previous episodes of urinary tract infection (UTI), even if only suspected (e.g. an episode of fever treated with antibiotics without performing urine culture);
- VUR grade I, because of the high probability of rapid spontaneous resolution;
- VUR grade V, as requested by the Technical Scientific Committee, concerned by the high incidence of associated renal dysplasia;
- recurrence of acute pyelonephritis before the first dimercaptosuccinic acid (DMSA) renal scan, if this was positive for scars.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382343
| Italy | |
| San Polo Hospital | |
| Monfalcone, Gorizia, Italy, 34170 | |
| San Daniele Hospital | |
| San Daniele, Udine, Italy, 33100 | |
| Sant'Antonio Abate Hospital | |
| Tolmezzo, Udine, Italy, 33028 | |
| Sant'Orsola Hospital | |
| Bologna, Italy, 48138 | |
| Bufalini Hospital | |
| Cesena, Italy, 47023 | |
| Santa Maria degli Angeli Hospital | |
| Pordenone, Italy, 33170 | |
| Institute of Child Health IRCCS Burlo Garofolo | |
| Trieste, Italy, 34137 | |
| Principal Investigator: | Marco Pennesi, MD | Institute of Child Health IRCCS Burlo Garofolo, Trieste, Italy |
| Responsible Party: | Ronfani Luca, MD, PhD, IRCCS Burlo Garofolo |
| ClinicalTrials.gov Identifier: | NCT00382343 |
| Other Study ID Numbers: |
RC 35/00 |
| First Posted: | September 29, 2006 Key Record Dates |
| Last Update Posted: | April 28, 2015 |
| Last Verified: | April 2015 |
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Prevention Pyelonephritis Renal scars Vesico-ureteral reflux Dimercaptosuccinic acid renal scan (DMSA) |
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Pyelonephritis Vesico-Ureteral Reflux Nephritis, Interstitial Nephritis Kidney Diseases Urologic Diseases Pyelitis Urinary Bladder Diseases Trimethoprim Trimethoprim, Sulfamethoxazole Drug Combination Sulfamethoxazole Anti-Infective Agents, Urinary |
Anti-Infective Agents Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Bacterial Agents |