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Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old
This study has been completed.
Study NCT00136656   Information provided by Assistance Publique - Hôpitaux de Paris
First Received: August 26, 2005   Last Updated: February 11, 2009   History of Changes

August 26, 2005
February 11, 2009
July 2005
June 2008   (final data collection date for primary outcome measure)
Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months [ Time Frame: between six and eight months ] [ Designated as safety issue: No ]
Renal scars on DMSA renal scan at 6 months
Complete list of historical versions of study NCT00136656 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time to get apyrexia
  • Incidence of urologic abnormalities on cystourethrography done during the first month after the the infection
 
Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old
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.

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.

Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Pyelonephritis
  • Drug: antibiotic
  • Drug: antibiotics
  • Active Comparator: cefixime antibiotic treatment by oral route
  • Sham Comparator: ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
700
February 2009
June 2008   (final data collection date for primary outcome measure)

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
Both
1 Month to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00136656
Thérèse NGOUE, Department Clinical Research of Developpement
P040422, AOM 04 105
Assistance Publique - Hôpitaux de Paris
 
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
Assistance Publique - Hôpitaux de Paris
February 2009

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