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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefixime; Ceftriaxone

Criteria

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