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| ID | Type | Description | Link |
|---|---|---|---|
| AOM 04 105 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | cefixime antibiotic treatment by oral route |
|
| 2 | Sham Comparator | ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antibiotic | Drug | cephalosporine by oral route : cefixime |
| |
| antibiotics |
| Measure | Description | Time Frame |
|---|---|---|
| Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months | between six and eight months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to get apyrexia | 4 days | |
| Incidence of urologic abnormalities on cystourethrography done during the first month after the infection | one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CHERON GERARD, MD | Hôpital Necker Enfants Malades Assistance Publique Hôpitaux de Paris - René Descartes University Paris 5 | Principal Investigator |
| CHEVALLIER BERTRAND, MD | Ambroise Paré Hospital, Assistance Publique Hôpitaux de Paris | Study Chair |
| GAJDOS VINCENT, MD | Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris | Study Chair |
| LABRUNE PHILIPPE, MD | Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris | Study Chair |
| GRIMPREL EMMANUEL, MD | Trousseau Hospital AP HP | Study Chair |
| DESCHENES GEORGES, MD | TROUSSEAU HOSPITAL AP-HP | Study Chair |
| SERGENT ALINE, MD | TROUSSEAU HOSPITAL AP-HP | Study Chair |
| VAYLET CLAIRE, MD | TROUSSEAU HOSPITAL AP-HP | Study Chair |
| BADER MEUNIER BRIGITTE, MD | BICETRE HOSPITAL AP-HP |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital de Bicetre | Bicêtre | 94275 | France | |||
| Hopital Pellegrin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10772296 | Background | Sannier N, Le Masne A, Sayegh N, Gaillard JL, Cheron G. Ambulatory management of acute pyelonephritis in children. Acta Paediatr. 2000 Mar;89(3):372-3. No abstract available. | |
| 15890693 | Background | Leroy S, Marc E, Adamsbaum C, Gendrel D, Breart 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. doi: 10.1136/adc.2004.068205. Epub 2005 May 12. |
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| Drug |
cephalosporine : ceftriaxone by intra venous route and cefixime by oral route |
|
| GUIGONIS VINCENT, MD | DUPUYTREN HOSPITAL CHU LIMOGES | Study Chair |
| Bordeaux |
| 33000 |
| France |
| Hôpital Ambroise Pare | Boulogne | 92100 | France |
| Hôpital Antoine Beclere | Clamart | 92141 | France |
| Chu de Limoges | Limoges | 87042 | France |
| La Timone | Marseille | 13385 | France |
| CHU NICE | Nice | 06000 | France |
| Saint Vincent de Paul | Paris | 75014 | France |
| Necker Enfants Malades | Paris | 75015 | France |
| Robert Debre | Paris | 75019 | France |
| Hôpital Armand Trousseau | Paris | 75571 | France |
| Hopital Andre Mignot | Versailles | 78150 | France |
| 15867014 | Background | Leroy S, Adamsbaum C, Marc E, Moulin F, Raymond J, Gendrel D, Breart 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. doi: 10.1542/peds.2004-1631. Epub 2005 May 2. |
| 11998420 | Background | Marc E, Menager C, Moulin F, Stos B, Chalumeau M, Guerin 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. doi: 10.1016/s0929-693x(01)00793-x. French. |
| 22291112 | Derived | Bocquet N, Sergent Alaoui A, Jais JP, Gajdos V, Guigonis V, Lacour B, Cheron G. Randomized trial of oral versus sequential IV/oral antibiotic for acute pyelonephritis in children. Pediatrics. 2012 Feb;129(2):e269-75. doi: 10.1542/peds.2011-0814. Epub 2012 Jan 30. |
| ID | Term |
|---|---|
| D011704 | Pyelonephritis |
| ID | Term |
|---|---|
| D009395 | Nephritis, Interstitial |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011702 | Pyelitis |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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