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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00136656
First received: August 26, 2005
Last updated: February 11, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Pyelonephritis
Drug: antibiotic
Drug: antibiotics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months [ Time Frame: between six and eight months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to get apyrexia [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
  • Incidence of urologic abnormalities on cystourethrography done during the first month after the infection [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Enrollment: 700
Study Start Date: July 2005
Study Completion Date: February 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
cefixime antibiotic treatment by oral route
Drug: antibiotic
cephalosporine by oral route : cefixime
Other Name: antibiotic
Sham Comparator: 2
ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days
Drug: antibiotics
cephalosporine : ceftriaxone by intra venous route and cefixime by oral route
Other Name: antibiotics

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 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.

  Eligibility

Ages Eligible for Study:   1 Month to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136656

Locations
France
Hopital de Bicetre
Bicetre, France, 94275
Hopital Pellegrin
Bordeaux, France, 33000
Hôpital Ambroise Pare
Boulogne, France, 92100
Hôpital Antoine Beclere
Clamart, France, 92141
Chu de Limoges
Limoges, France, 87042
La Timone
Marseille, France, 13385
CHU NICE
Nice, France, 06000
Saint Vincent de Paul
Paris, France, 75014
Robert Debre
Paris, France, 75019
Hôpital Armand Trousseau
Paris, France, 75571
Necker Enfants Malades
Paris, France, 75015
Hopital Andre Mignot
Versailles, France, 78150
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: CHERON GERARD, MD Hôpital Necker Enfants Malades Assistance Publique Hôpitaux de Paris - René Descartes University Paris 5
Study Chair: 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
Study Chair: GUIGONIS VINCENT, MD DUPUYTREN HOSPITAL CHU LIMOGES
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thérèse NGOUE, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00136656     History of Changes
Other Study ID Numbers: P040422, AOM 04 105
Study First Received: August 26, 2005
Last Updated: February 11, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
infant
children
pyelonephritis
Renal scars
DMSA scan

Additional relevant MeSH terms:
Pyelonephritis
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis
Anti-Bacterial Agents
Ceftriaxone
Cefixime
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 28, 2014