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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00136656

Enrollment

700

Registered

2005-08-29

Start date

2005-07-31

Completion date

2009-02-28

Last updated

2009-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyelonephritis

Keywords

infant, children, pyelonephritis, Renal scars, DMSA scan

Brief summary

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

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.

Interventions

DRUGantibiotic

cephalosporine by oral route : cefixime

DRUGantibiotics

cephalosporine : ceftriaxone by intra venous route and cefixime by oral route

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 3 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months	between six and eight months

Secondary

Measure	Time frame
Time to get apyrexia	4 days
Incidence of urologic abnormalities on cystourethrography done during the first month after the infection	one month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026