Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the equivalence of the therapeutic efficacy of cefixime by mouth (PO) 10 days (d) and ceftriaxone intravenous route(IV) 4d followed by cefixime PO 6d on renal scars 6 months after a first acute pyelonephritis episode. The investigators hypothesize that treatment with cefixime PO will allow no more renal scars than intravenous route (IV) treatment of pyelonephritis in infants and children less than 3 years old, 6 months after the first episode. If it is true, treatment will no longer need hospitalisation and the advantages for children, families and the health system will be very important.

Detailed Description
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Guidelines for treatment of acute pyelonephritis in infants and children are different from one country to another. The main question is the incidence of renal scars. intravenous route (IV) treatment is supposed to give the best results, but no previous study has ever given the incidence of renal scars after PO treatment. This multicenter, randomised trial is an equivalence study of PO and intravenous route (IV) treatments.

Official Title
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Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old. Cefixime PO 10d vs Ceftriaxone IV 4d Followed by Cefixime PO 6d. Multicenter, Randomised Trial of Equivalence.

Conditions
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Pyelonephritis

Intervention / Treatment
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* Drug: antibiotic
* Drug: antibiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants and children more than 1 month old and less than 3 years old First episode of acute pyelonephritis with gram negative strains Fever more than 38.5°C Procalcitonin (PCT) value > 0.5 ng/ml Urine obtained by transurethral bladder catheterization, suprapubic aspiration or midstream collection Urine exam: more than 100.000 leukocytes and gram negative strains + Normal hemodynamic exam Normal renal ultrasonography Positive DMSA renal scan for pyelonephritis during the first week after diagnosis Parental informed consent Exclusion Criteria: Newborn Children more than 3 years old Past urine infection Septic hemodynamic abnormalities Obstructive uropathy and any renal ultrasonography abnormalities Allergy to cefixime or ceftriaxone Antibiotic during the five previous days Gastrointestinal abnormalities able to interfere with antibiotic intake or absorption Absence of parental consent Social familial difficulties

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>cefixime antibiotic treatment by oral route | Drug: antibiotic<br>* cephalosporine by oral route : cefixime<br>|
| Sham Comparator: 2<br>ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days | Drug: antibiotics<br>* cephalosporine : ceftriaxone by intra venous route and cefixime by oral route<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months |  | between six and eight months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to get apyrexia |  | 4 days | 
| Incidence of urologic abnormalities on cystourethrography done during the first month after the infection |  | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, children, pyelonephritis, Renal scars, DMSA scan