Health Condition 1: N390- Urinary tract infection, site notspecified
Conditions
Interventions
Intervention1: Intravenous and oral antibiotics: i)Cefoperazone-sulbactum (50 mg/kg/dose of cefoperazone q 8 hrly) is the parenteral antibiotic that will be administered
ii) Syrup Cefpodoxime (10 mg/
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 3 months to 18 years admitted with 1. Fever and/or other symptoms of urinary tract infection (dysuria, abdominal pain, cloudy urine, increased frequency or urgency) 2. Positive urine culture (defined as growth of a single organism greater than 10^3 CFU/mL in suprapubic aspirate or 10^4 CFU/mL in a midstream clean-catch or catheterized sample) 3. Structural congenital anomalies of the kidney and urinary tract such as high-grade (grades III-V) vesicoureteric reflux, posterior urethral valves, neurogenic bladder, ureterocele, pelviureteric junction obstruction or duplex collecting system 4. Improvement in clinical symptoms along with defervescence of fever within 72 hours of starting antibiotic therapy
Exclusion criteria
Exclusion criteria: 1. Children with immunodeficiency (primary or secondary) or on immunosuppressive therapy 2. Known sulfa allergy 3. Children who have been receiving IV antibiotic therapy for more than 72 hours prior to enrolment 4. Concomitant infections requiring prolonged IV antibiotics such as urosepsis, perinephric abscess, meningitis etc. 5. Urine culture at the time of index hospitalisation showing resistance to the oral study drug 6. Prior enrolment into the same study 7. Children who underwent genitourinary surgery in the preceding 7 days prior to randomization 8. Children with estimated glomerular filtration rate below 30 ml/min/1.73 m2
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To compare the 1. proportion with recurrence of afebrile urinary tract infection within 4 weeks 2. proportion with asymptomatic bacteriuria and sterile urine culture at the end of therapy (day 7) 3. antibiotic resistance pattern between both the groups in those with asymptomatic bacteriuria at the end of therapy (day 7) 4. Feasibility objectives (since this is a pilot RCT) a. Proportion of patients excluded after initial screening or withdrawn from the study after randomization b. Proportion of patients with afebrile urinary tract infection or non-improvement in clinical symptoms or fever defervescence within 72 hours of starting antibiotic therapy c. Proportion of patients with sterile urine culture or culture showing resistance to the oral study drug Timepoint: 1- 4 weeks 2,3 - 7 days | — |
Primary
| Measure | Time frame |
|---|---|
| In children aged 3 months to 18 years with underlying structural urinary tract abnormality admitted with an urinary tract infection, to compare the proportion of patients with recurrence of febrile urinary tract infection within 4 weeks of antibiotic completion between early switch (3 days intravenous followed by 4 days oral) and standard intravenous (7 days) antibiotic regimensTimepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr SUDARSAN K
JIPMER, Puducherry
Outcome results
None listed