Fosfomycin Vs Ciprofloxacin as Oral Step-Down Treatment for Escherichia coli Febrile Urinary Tract Infections in Women: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial
| Autor: | Thijs ten Doesschate, Forecast study team, Wouter van den Bijllaardt, Robert-Jan Hassing, Judith Branger, Suzanne E. Geerlings, Cornelis H. van Werkhoven, Marc J. M. Bonten, Tom Ketels, Ad Koster, Andy I. M. Hoepelman, Cees van Nieuwkoop, Suzan P. van Mens, Akke K. van der Bij, Evert L Koldewijn, S G Kuiper |
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| Přispěvatelé: | Med Microbiol, Infect Dis & Infect Prev, MUMC+: DA MMI Staf (9), RS: FHML non-thematic output, Internal medicine, Infectious diseases, AII - Infectious diseases, APH - Quality of Care |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Adult
Microbiology (medical) medicine.medical_specialty Fever medicine.drug_class Antibiotics Fosfomycin Placebo law.invention Double-Blind Method Randomized controlled trial Ciprofloxacin law Multicenter trial Internal medicine Major Article medicine Clinical endpoint Escherichia coli Humans antimicrobial resistance Adverse effect fosfomycin Escherichia coli Infections business.industry COVID-19 biochemical phenomena metabolism and nutrition Anti-Bacterial Agents AcademicSubjects/MED00290 Infectious Diseases Urinary Tract Infections Female business urinary tract infection PYELONEPHRITIS medicine.drug |
| Zdroj: | Clinical Infectious Diseases, 75(2), 221-229. Oxford University Press Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America FORECAST Study Team 2022, ' Fosfomycin Vs Ciprofloxacin as Oral Step-Down Treatment for Escherichia coli Febrile Urinary Tract Infections in Women : A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial ', Clinical Infectious Diseases, vol. 75, no. 2, pp. 221-229 . https://doi.org/10.1093/cid/ciab934 Clinical infectious diseases, 75(2), 221-229. Oxford University Press |
| ISSN: | 1058-4838 |
| DOI: | 10.1093/cid/ciab934 |
| Popis: | Background We aimed to determine the noninferiority of fosfomycin compared to ciprofloxacin as an oral step-down treatment for Escherichia coli febrile urinary tract infections (fUTIs) in women. Methods This was a double-blind, randomized, controlled trial in 15 Dutch hospitals. Adult women who were receiving 2–5 days of empirical intravenous antimicrobials for E. coli fUTI were assigned to step-down treatment with once-daily 3g fosfomycin or twice-daily 0.5g ciprofloxacin for 10 days of total antibiotic treatment. For the primary end point, clinical cure at days 6–10 post-end of treatment (PET), a noninferiority margin of 10% was chosen. The trial was registered on Trialregister.nl (NTR6449). Results After enrollment of 97 patients between 2017 and 2020, the trial ended prematurely because of the coronavirus disease 2019 pandemic. The primary end point was met in 36 of 48 patients (75.0%) assigned to fosfomycin and 30 of 46 patients (65.2%) assigned to ciprofloxacin (risk difference [RD], 9.6%; 95% confidence interval [CI]: –8.8% to 28.0%). In patients assigned to fosfomycin and ciprofloxacin, microbiological cure at days 6–10 PET occurred in 29 of 37 (78.4%) and 33 of 35 (94.3%; RD, –16.2%; 95% CI: –32.7 to –0.0%). Any gastrointestinal adverse event was reported in 25 of 48 (52.1%) and 14 of 46 (30.4%) patients (RD, 20.8%; 95% CI: 1.6% to 40.0%), respectively. Conclusions Fosfomycin is noninferior to ciprofloxacin as oral step-down treatment for fUTI caused by E. coli in women. Fosfomycin use is associated with more gastrointestinal events. Clinical Trial Registration Trial NL6275 (NTR6449). Fosfomycin is noninferior to ciprofloxacin regarding clinical cure as a targeted oral step-down treatment for Escherichia colifebrile urinary tract infections in women. Its use could prevent extended hospitalization in cases of resistance, intolerance, or allergies to existing step-down antibiotics. |
| Databáze: | OpenAIRE |
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