Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT00136656
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
3 Years
Study:
NCT00136656
Study Brief:
Protocol Section:
NCT00136656