Pivmecillinam as oral step-down treatment for Escherichia coli febrile urinary tract infection versus standard of care; a randomized controlled non-inferiority multicenter trial

febrile Urinary Tract Infection (fUTI)

Clinical response: i) no new healthcare contacts or antibiotic treatments for suspected or proven UTI, ii) sustained defervescence (< 38°C), and iii) patient-documented resolution of fUTI symptoms that were present and recorded in the eCRF at trial entry (and no new fUTI symptoms) at test of cure (TOC), which will be performed 7 (+/-2) days after EOT.

Sustained clinical response: i) no new healthcare contacts or antibiotic treatments for suspected or proven UTI, ii) no recurrent fever (≥ 38°C), and iii) no recurrent UTI symptoms after completion of the initial therapy and until 28 (+/- 2) days after EOT., Microbiological response: no detectable growth of E. coli in urine sampled at TOC, 7 (+/-2) days after EOT., Sustained microbiological response; no detectable growth of E. coli in urine sampled at the second follow-up 28 (+/- 2) days after EOT., Occurrence and severity of AEs from start of study treatment until TOC: recorded by the participating patients in a diary, documented in the medical records, or reported at the TOC follow-up., Disturbances in the intestinal microbiome: analysed by repeated collection of fecal samples from 30 patients treated with pivmecillinam or ciprofloxacin, respectively., Pharmacokinetics of mecillinam in plasma and urine and PK/PD target attainment; assessed by blood and urine sampling from 30 patients treated with pivmecillinam., Cost-effectiveness of pivmecillinam as compared with standard of care.

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Norway, Sweden