Therapy of cystitis with nitroxoline-NitroxWin : Prospective, multicenter, non-interventional study and microbiological resistance surveillance

Abstract

According to German AWMFS3 guideline nitroxoline is recommended as one of the first-choice antibiotics for treatment of acute uncomplicated cystitis (UC) in women. Under real-world conditions the clinical efficacy of nitroxoline should be checked in anoninterventional, prospective and multicenter study (NIS) and the prevalence of nitroxoline resistance in E.coli be monitored. Female patients with UC treated with nitroxoline (recommended dosage 250 mg tid for 5days) were included by urologists, general practitioners (GPs), and internists in family medicine throughout Germany from April-December 2022 and followed for 21-28days. The diagnosis and course of therapy were judged by the Acute Cystitis Symptom Score (ACSS) questionnaire and laboratory investigations (leukocyturia etc). Separately, anationwide resistance surveillance was performed during 2019-2020 in collaboration with 23laboratories to collect urinary E.coli isolates and test their susceptibility to nitroxoline. Of the 316 patients with mean (SD) age of 57.2 (±20.4 [median 62.5]) years who were included in the NIS, 193/248 (86.3%) in the per-protocol group and in 193/263 (81.44%) in the intention-to-treat group were clinically successful. Furthermore, 96% of the patients rated the tolerability of nitroxoline as "very good" or "good". All 272 E.coli isolates tested were susceptible to nitroxoline. Nitroxoline showed very good clinical results in the NIS, and 100% of the tested E.coli urine isolates were susceptible to nitroxoline. Nitroxoline can still be recommended as one of the first-choice antibiotics for treatment of UC in women.