Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT00136656
Status:
COMPLETED
Last Update Posted:
2009-02-12
First Post:
2005-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011704', 'term': 'Pyelonephritis'}], 'ancestors': [{'id': 'D009395', 'term': 'Nephritis, Interstitial'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011702', 'term': 'Pyelitis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-11', 'studyFirstSubmitDate': '2005-08-26', 'studyFirstSubmitQcDate': '2005-08-26', 'lastUpdatePostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months', 'timeFrame': 'between six and eight months'}], 'secondaryOutcomes': [{'measure': 'Time to get apyrexia', 'timeFrame': '4 days'}, {'measure': 'Incidence of urologic abnormalities on cystourethrography done during the first month after the infection', 'timeFrame': 'one month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['infant', 'children', 'pyelonephritis', 'Renal scars', 'DMSA scan'], 'conditions': ['Pyelonephritis']}, 'referencesModule': {'references': [{'pmid': '10772296', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15890693', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15867014', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11998420', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22291112', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nintravenous 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.\n\nThis multicenter, randomised trial is an equivalence study of PO and intravenous route (IV) treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants and children more than 1 month old and less than 3 years old\n* First episode of acute pyelonephritis with gram negative strains\n* Fever more than 38.5°C\n* Procalcitonin (PCT) value \\> 0.5 ng/ml\n* Urine obtained by transurethral bladder catheterization, suprapubic aspiration or midstream collection\n* Urine exam: more than 100.000 leukocytes and gram negative strains +\n* Normal hemodynamic exam\n* Normal renal ultrasonography\n* Positive DMSA renal scan for pyelonephritis during the first week after diagnosis\n* Parental informed consent\n\nExclusion Criteria:\n\n* Newborn\n* Children more than 3 years old\n* Past urine infection\n* Septic hemodynamic abnormalities\n* Obstructive uropathy and any renal ultrasonography abnormalities\n* Allergy to cefixime or ceftriaxone\n* Antibiotic during the five previous days\n* Gastrointestinal abnormalities able to interfere with antibiotic intake or absorption\n* Absence of parental consent\n* Social familial difficulties'}, 'identificationModule': {'nctId': 'NCT00136656', 'briefTitle': 'Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'P040422'}, 'secondaryIdInfos': [{'id': 'AOM 04 105'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'cefixime antibiotic treatment by oral route', 'interventionNames': ['Drug: antibiotic']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': 'ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days', 'interventionNames': ['Drug: antibiotics']}], 'interventions': [{'name': 'antibiotic', 'type': 'DRUG', 'description': 'cephalosporine by oral route : cefixime', 'armGroupLabels': ['1']}, {'name': 'antibiotics', 'type': 'DRUG', 'description': 'cephalosporine : ceftriaxone by intra venous route and cefixime by oral route', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94275', 'city': 'Bicêtre', 'country': 'France', 'facility': 'Hopital de Bicetre', 'geoPoint': {'lat': 45.37764, 'lon': 4.44181}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hopital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92100', 'city': 'Boulogne', 'country': 'France', 'facility': 'Hôpital Ambroise Pare', 'geoPoint': {'lat': 46.79346, 'lon': -1.3194}}, {'zip': '92141', 'city': 'Clamart', 'country': 'France', 'facility': 'Hôpital Antoine Beclere', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Chu de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'CHU NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Saint Vincent de Paul', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Robert Debre', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Armand Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '78150', 'city': 'Versailles', 'country': 'France', 'facility': 'Hopital Andre Mignot', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}], 'overallOfficials': [{'name': 'CHERON GERARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Necker Enfants Malades Assistance Publique Hôpitaux de Paris - René Descartes University Paris 5'}, {'name': 'CHEVALLIER BERTRAND, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ambroise Paré Hospital, Assistance Publique Hôpitaux de Paris'}, {'name': 'GAJDOS VINCENT, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris'}, {'name': 'LABRUNE PHILIPPE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris'}, {'name': 'GRIMPREL EMMANUEL, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Trousseau Hospital AP HP'}, {'name': 'DESCHENES GEORGES, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'TROUSSEAU HOSPITAL AP-HP'}, {'name': 'SERGENT ALINE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'TROUSSEAU HOSPITAL AP-HP'}, {'name': 'VAYLET CLAIRE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'TROUSSEAU HOSPITAL AP-HP'}, {'name': 'BADER MEUNIER BRIGITTE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'BICETRE HOSPITAL AP-HP'}, {'name': 'GUIGONIS VINCENT, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'DUPUYTREN HOSPITAL CHU LIMOGES'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Thérèse NGOUE', 'oldOrganization': 'Department Clinical Research of Developpement'}}}}