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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 4

Conditions: Pyelonephritis

Treatments: Drug: antibiotic; Drug: antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT00136656

P040422

AOM 04 105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 patients

Sex: All

Ages: 1 month to 3 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

1

Active Comparator group

Description:

cefixime antibiotic treatment by oral route

Treatment:

Drug: antibiotic

2

Sham Comparator group

Description:

ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days

Treatment:

Drug: antibiotics