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Randomised controlled trial on efficacy and safety of short term versus long term antibiotic therapy for pyelonephritis in childhood. - Short term antibiotic therapy for pyelonephritis in childhood.

Randomised controlled trial on efficacy and safety of short term versus long term antibiotic therapy for pyelonephritis in childhood. - Short term antibiotic therapy for pyelonephritis in childhood.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003209-16-IT
Enrollment
Unknown
Registered
2008-07-18
Start date
2008-07-07
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pyelonephritis MedDRA version: 9.1 Level: LLT Classification code 10037596 Term: Pyelonephritis

Interventions

Product Name: Ceftibuten Pharmaceutical Form: Oral suspension INN or Proposed INN: Ceftibuten Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 36- Pro

Sponsors

ISTITUTO PER L'INFANZIA BURLO GAROFOLO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children aged 1 month to 5 years, with a first episode of upper urinary infection (pyelonephritis). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Children less than 1 month, or older than 5 years. Relapse of pyelonephritis. Sepsis and/or vomiting, or other conditions where it?s impossible to administer an oral therapy. Allergy to ceftibuten. Previous antibiotic therapy for the same infection. Long term antibiotic prophylaxis with an antibiotic of the same class, if laboratory antibiotic resistance is shown. Children with uncontrolled other disease. Complicated pyelonephritis (abscess).

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluate efficacy of oral ceftibuten for 7 days versus ceftibuten for 10 days in acute pyelonephritis in children.;Secondary Objective: Evaluate procalcitonine predictive value for renal scar after acute pyelonephritis.;Primary end point(s): RENAL SCAR ( after 6-12 months)—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026