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NCT Number: NCT00136656

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

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.

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Key information

Conditions

Pyelonephritis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Interstitial Pyelitis Urogenital Diseases Urologic Diseases

Age range

1 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital de Bicetre, Bicêtre, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic

Drug

cephalosporine by oral route : cefixime

Antibiotics

Drug

cephalosporine : ceftriaxone by intra venous route and cefixime by oral route

Primary outcomes

  1. Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months

    Time frame: between six and eight months

Secondary outcomes

  1. Time to get apyrexia

    Time frame: 4 days

  2. Incidence of urologic abnormalities on cystourethrography done during the first month after the infection

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Aug 29, 2005
Registry last updated
Feb 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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