Acute pyelonephritis in children 1 month to 3 years old
Conditions
Interventions
Trade Name: Amikacin
Pharmaceutical Form:
INN or Proposed INN: Amikacin
CAS Number: 37517-28-5
Trade Name: Ceftriaxone
Pharmaceutical Form:
INN or Proposed INN: Ceftriaxone
CAS Number: 73384-59-5
Sponsors
APHP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 1 month = Age 34 WGA - First episode of urinary tract infection. - AP defined by temperature = 38°C on day of diagnosis AND positive urinalysis (white cell counts = 104/mL) AND Gram-negative rods in Gram-stained urine - Initial treatment by either ceftriaxone AND/OR amikacin. - Outpatient or hospitalised Are the trial subjects under 18? yes Number of subjects for this age range: 558 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: - Urine collected by bag. - Urine culture growing more than one bacteria. - Catheter-associated AP. - Known congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation < 10 mm). - Previous surgery of the genitourinary tract (except circumcision in male children). - Abnormal renal function for age and weight - Immunocompromising condition (e.g., HIV, primary immunodeficiency, sickle cell disease, use of chronic corticosteroids or other immunosuppressive agents). - A history of AP or other urinary tract infection. - Antibiotic prophylaxis for any reason OR antibiotic treatment in the last 7 days. - Known hypersensitivity to at least one of the active substances /excipients: ceftriaxone (include cephalosporin et beta-lactams)and amikacin (include aminoside)Known hypersensitivity to at least one of the active substances /excipients: cotrimoxazole (=sulfamethoxazole/trimethoprim) (include sulfonamide) and cefixime (include cephalosporin) - Known hypersensitivity to 99mTc-DMSA (medicinal product used for renal scintigraphy) - Severe hepatic insufficiency (transaminases = 3N) - Known G6PD deficiency - No written consent from holders of parental authority, or refusal of the child to participate - Non-affiliation of the child in a social security (as beneficiary or entitled person) - Children whose follow-up is not carried out in the centre - Participation in another interventional or minimal risk trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to demonstrate the non-inferiority of a 3-day intravenous (IV) antibiotic therapy versus a 3-day IV therapy followed by a 7-day oral antibiotic therapy for the treatment of AP in children on the occurrence of renal scarring. ;Secondary Objective: ;Primary end point(s): ;Timepoint(s) of evaluation of this end point: The primary endpoint is the occurrence of renal scaring, as measured by cortical defect by dimercaptosuccinic acid (99mTc-DMSA) renal scintigraphy at 6 months after the beginning of therapy (day 180 ± 15 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Secondary endpoints: - Clinical cure at the end of the antibiotic treatment (day 14 ± 3 days), defined by apyrexia AND no abdominal pain AND no feeding problem: medical visit. - Recurrent infection (including AP relapse or reinfection) within 90 days after the beginning of therapy (day 90 ± 15 days): phone call - Colonization with antimicrobial resistant Enterobacteriaceae in the gastrointestinal tract between at days 3 and 14. - Alpha-diversity measured by Shannon’s index at days 3, 14 and 45 | — |
Countries
France
Contacts
Public ContactProject Manager
APHP
Outcome results
None listed