Status:
COMPLETED
Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pyelonephritis
Eligibility:
All Genders
1-3 years
Phase:
PHASE4
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 ren...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00136656
Start Date
July 1 2005
End Date
February 1 2009
Last Update
February 12 2009
Active Locations (12)
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1
Hopital de Bicetre
Bicêtre, France, 94275
2
Hopital Pellegrin
Bordeaux, France, 33000
3
Hôpital Ambroise Pare
Boulogne, France, 92100
4
Hôpital Antoine Beclere
Clamart, France, 92141