Pyelonephritis Clinical Trial
Official title:
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.
Verified date | February 2009 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 700 |
Est. completion date | February 2009 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 3 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hopital de Bicetre | Bicetre | |
France | Hopital Pellegrin | Bordeaux | |
France | Hôpital Ambroise Pare | Boulogne | |
France | Hôpital Antoine Beclere | Clamart | |
France | Chu de Limoges | Limoges | |
France | La Timone | Marseille | |
France | CHU NICE | Nice | |
France | Hôpital Armand Trousseau | Paris | |
France | Necker Enfants Malades | Paris | |
France | Robert Debre | Paris | |
France | Saint Vincent de Paul | Paris | |
France | Hopital Andre Mignot | Versailles |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Leroy S, Adamsbaum C, Marc E, Moulin F, Raymond J, Gendrel D, Bréart G, Chalumeau M. Procalcitonin as a predictor of vesicoureteral reflux in children with a first febrile urinary tract infection. Pediatrics. 2005 Jun;115(6):e706-9. Epub 2005 May 2. — View Citation
Leroy S, Marc E, Adamsbaum C, Gendrel D, Bréart G, Chalumeau M. Prediction of vesicoureteral reflux after a first febrile urinary tract infection in children: validation of a clinical decision rule. Arch Dis Child. 2006 Mar;91(3):241-4. Epub 2005 May 12. — View Citation
Marc E, Ménager C, Moulin F, Stos B, Chalumeau M, Guérin S, Lebon P, Brunet F, Raymond J, Gendrel D. [Procalcitonin and viral meningitis: reduction of unnecessary antibiotics by measurement during an outbreak]. Arch Pediatr. 2002 Apr;9(4):358-64. French. — View Citation
Sannier N, Le Masne A, Sayegh N, Gaillard JL, Chéron G. Ambulatory management of acute pyelonephritis in children. Acta Paediatr. 2000 Mar;89(3):372-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months | between six and eight months | No | |
Secondary | Time to get apyrexia | 4 days | Yes | |
Secondary | Incidence of urologic abnormalities on cystourethrography done during the first month after the infection | one month | Yes |
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