Dettagli per singolo studio

DEC-NET Serial number FR509

Published online	24/10/2005 12.18.00
Last updated	27/11/2006 12.27.50

Other protocol ID number
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	ACUTE PYELONEPHRITIS WITH LESION OF RENAL MEDULLAR
Experimental drug
cefixime Treatment regimen (dosage and duration) After a first administration of cefixime of 8mg/kg with H0, the treatment is continued at H12 with 4mg/kg twice per day. Duration of treatment is 10 days.
ceftriaxone Treatment regimen (dosage and duration) Ceftriaxone 50mg/kg/day
Control drug
ceftriaxone + cefixime Treatment regimen (dosage and duration) Monotherapy by ceftriaxone 50mg/kg/d, 4 injections then followed by 4 mg/kg cefixime PO twice per day for 6 days(10 days treatment)
Gender	Both
Age (range)	1- 3 years
Eligibility criteria
Inclusion criteria
- Infants and children more than 1 month and less than 3 years old -First episode of acute pyelonephritis with gram negative strains -Fever more than 38°5 ,PCT ≥ 0.5ng/ml, -Leukoturia ≥ 105/ml and gram negative strains + -Normal hemodynamics and normal renal ultrasonography -Positive DMSA renal scan for pyelonephritis during the first week after diagnosis. -Parental informed consent.
Exclusion criteria
Children with at least one of the following criteria: -Newborn and children more than 3 years old -Pasthistory of urinary infection -Septic hemodynamic dysfunction -Obstructive uropathy and any renal ultrasonography abnormalities -Allergy to cefixime or ceftriaxone -Gastrointestinal disorders that might interfere with antibiotic intake or absorption. -Antibiotic treatment during the five previous days. -Absence of parental consent and Social familial difficulties
Trial design/methodology
Phase	4
Kind of study	Efficacy
Design	Controlled Randomised Blinded Single blind
Purpose of study
Primary objective: To demonstrate the equivalence of cefixime PO 10d and ceftriaxone IV 4d followed by cefixime PO 6d on renal scars 6 months to treat a first acute pyelonephritis. Secondary objectives : - Fever duration - Recidive of the urinary infection in the first month, then beyond the first month - Vesico-ureteral reflux or vesical anomaly and/or ureteral in the cystography.
Primary outcomes
Renal scars on DMSA renal scan at 6 months
Secondary outcomes
- Time to get apyrexia - Incidence of apyrexia at d4 - Incidence of urologic abnormalities on cystourethrography done during the first month after the the infection.
Summary of study design, objectives, and ongoing research findings
Multicenter, randomised equivalence trial of conventional treatment by ceftriaxone IV 4 days followed cefixime PO 6 days versus cefixime PO 10 days in the treatment of acute pyelonephritis with Gram negative strains in infants. Primary outcome : Renal scars on DMSA renal scan at sixth months.