NCT07902427|CompletedPhase 4
Oral Fosfomycin as Sequential Oral Treatment for Multidrug-Resistant Escherichia Coli in Acute Bacterial Prostatitis
FOS-PROST
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FOS-PROST
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
88
1 country
7
Study Start
January 25, 2022
Actual (reported)Primary Completion
March 18, 2026
Actual (reported)Study Completion
June 30, 2026
Actual (reported)FOS-PROST was a prospective, non-randomized, controlled phase IV clinical trial designed to evaluate the clinical and microbiological efficacy of oral fosfomycin trometamol as sequential antibiotic therapy in patients with acute bacterial prostatitis caused by multidrug-resistant \*Escherichia coli\*. According to the study protocol, patients with multidrug-resistant \*E. coli\* were assigned to receive oral fosfomycin trometamol, whereas patients with non-multidrug-resistant \*E. coli\* were assigned to receive conventional oral antibiotic treatment with ciprofloxacin or trimethoprim-sulfamethoxazole, according to antimicrobial susceptibility testing. All patients received 1 to 5 days of appropriate intravenous antibiotic therapy before switching to oral treatment. Fosfomycin trometamol was administered at a standard dose of 3 g once daily. The planned total duration of antibiotic treatment was 21 days in both groups, including intravenous and oral therapy. During study conduct, some patients with non-multidrug-resistant \*E. coli\* also received fosfomycin. All patients with multidrug-resistant \*E. coli\* received fosfomycin. Clinical and microbiological outcomes were compared between treatment groups. Secondary objectives included evaluating carbapenem consumption, hospital length of stay, safety, recurrence, and fosfomycin pharmacokinetics.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 27, 2020
Actual (reported)January 25, 2022
Actual (reported)March 18, 2026
Actual (reported)June 30, 2026
Actual (reported)October 28, 2026
Actual (reported)Percentage of Participants With Clinical Cure
Clinical cure was defined as the resolution of all symptoms present at baseline without the need for additional antibiotic treatment. Clinical cure required the absence of fever (axillary temperature greater than 38°C), urinary symptoms (dysuria, urinary frequency, urgency, or suprapubic pain), and altered level of consciousness if present at baseline.
Day 21 ± 3 days from treatment initiation (end of treatment)
Percentage of Participants With Microbiological Cure
Microbiological cure was defined as a negative urine culture at the end of antibiotic treatment. Only participants with an available urine culture at the end-of-treatment assessment were included in the analysis of this outcome. Participants without an available urine culture were excluded from the microbiological cure analysis.
Day 21 ± 3 days from treatment initiation (end of treatment).
Estimated Carbapenem Defined Daily Doses (DDDs) Avoided per Patient
During the 21-day antibiotic treatment period.
Hospital Length of Stay in Days
During the hospital admission for the acute bacterial prostatitis episode.
Estimated Hospitalization Days Avoided per Patient
During the 21-day antibiotic treatment period
Plasma Fosfomycin Concentration
At 1, 2, 4, 12, and 24 hours after the first oral fosfomycin dose; additional trough concentrations during hospitalization or at Visit 4, as applicable.
Percentage of Participants Experiencing Adverse Events
From treatment initiation through Day 51 (± 7 days).
Adult male patients with acute bacterial prostatitis caused by multidrug-resistant Escherichia coli, according to the Magiorakos criteria, assigned to receive sequential oral fosfomycin trometamol at a standard dose of 3 g every 24 hours after 1 to 5 days of appropriate intravenous antibiotic therapy.
Adult male patients with acute bacterial prostatitis caused by non-multidrug-resistant Escherichia coli, assigned to receive sequential oral antibiotic treatment with ciprofloxacin or trimethoprim-sulfamethoxazole, according to antimicrobial susceptibility testing, after 1 to 5 days of appropriate intravenous antibiotic therapy.
Oral fosfomycin trometamol, 3 g every 24 hours, administered as sequential antibiotic therapy after 1 to 5 days of appropriate intravenous antibiotic treatment, once clinical stability and oral tolerance were achieved. The planned total duration of antibiotic treatment, including intravenous and oral therapy, was 21 days. Dose adjustments for renal impairment were specified in the protocol.
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Hospital Universitari Parc Taulí
Sabadell, Barcelona, 08208, Spain
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, 08970, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital de Terrassa
Terrassa, Catalonia, 08227, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36312, Spain
Rodriguez-Bano J, Pascual A. Clinical significance of extended-spectrum beta-lactamases. Expert Rev Anti Infect Ther. 2008 Oct;6(5):671-83. doi: 10.1586/14787210.6.5.671.
Hernandez JR, Martinez-Martinez L, Canton R, Coque TM, Pascual A; Spanish Group for Nosocomial Infections (GEIH). Nationwide study of Escherichia coli and Klebsiella pneumoniae producing extended-spectrum beta-lactamases in Spain. Antimicrob Agents Chemother. 2005 May;49(5):2122-5. doi: 10.1128/AAC.49.5.2122-2125.2005.
88 participants (actual enrollment reported by the registry).
First Submitted
January 27, 2020
First Posted
October 28, 2026
Detection of Biofilm Among Uropathogenic Escherichia Coli Clinical Isolates in Suez Canal University Hospitals
Oral ciprofloxacin, 500 mg every 12 hours, administered as sequential antibiotic therapy according to antimicrobial susceptibility testing, following 1 to 5 days of appropriate intravenous antibiotic treatment. The planned total duration of antibiotic therapy was 21 days.
Oral trimethoprim-sulfamethoxazole, 160 mg/800 mg every 12 hours, administered as sequential antibiotic therapy according to antimicrobial susceptibility testing, following 1 to 5 days of appropriate intravenous antibiotic treatment. The planned total duration of antibiotic therapy was 21 days.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Boix-Palop L, Xercavins M, Badia C, Obradors M, Riera M, Freixas N, Perez J, Rodriguez-Carballeira M, Garau J, Calbo E. Emerging extended-spectrum beta-lactamase-producing Klebsiella pneumoniae causing community-onset urinary tract infections: a case-control-control study. Int J Antimicrob Agents. 2017 Aug;50(2):197-202. doi: 10.1016/j.ijantimicag.2017.03.009. Epub 2017 May 24.
Tzouvelekis LS, Markogiannakis A, Psichogiou M, Tassios PT, Daikos GL. Carbapenemases in Klebsiella pneumoniae and other Enterobacteriaceae: an evolving crisis of global dimensions. Clin Microbiol Rev. 2012 Oct;25(4):682-707. doi: 10.1128/CMR.05035-11.
Falagas ME, Maraki S, Karageorgopoulos DE, Kastoris AC, Mavromanolakis E, Samonis G. Antimicrobial susceptibility of multidrug-resistant (MDR) and extensively drug-resistant (XDR) Enterobacteriaceae isolates to fosfomycin. Int J Antimicrob Agents. 2010 Mar;35(3):240-3. doi: 10.1016/j.ijantimicag.2009.10.019.
de Cueto M, Lopez L, Hernandez JR, Morillo C, Pascual A. In vitro activity of fosfomycin against extended-spectrum-beta-lactamase-producing Escherichia coli and Klebsiella pneumoniae: comparison of susceptibility testing procedures. Antimicrob Agents Chemother. 2006 Jan;50(1):368-70. doi: 10.1128/AAC.50.1.368-370.2006.
Falagas ME, Kastoris AC, Kapaskelis AM, Karageorgopoulos DE. Fosfomycin for the treatment of multidrug-resistant, including extended-spectrum beta-lactamase producing, Enterobacteriaceae infections: a systematic review. Lancet Infect Dis. 2010 Jan;10(1):43-50. doi: 10.1016/S1473-3099(09)70325-1.
Michalopoulos AS, Livaditis IG, Gougoutas V. The revival of fosfomycin. Int J Infect Dis. 2011 Nov;15(11):e732-9. doi: 10.1016/j.ijid.2011.07.007. Epub 2011 Sep 25.
Raz R. Fosfomycin: an old--new antibiotic. Clin Microbiol Infect. 2012 Jan;18(1):4-7. doi: 10.1111/j.1469-0691.2011.03636.x. Epub 2011 Sep 13.
Roussos N, Karageorgopoulos DE, Samonis G, Falagas ME. Clinical significance of the pharmacokinetic and pharmacodynamic characteristics of fosfomycin for the treatment of patients with systemic infections. Int J Antimicrob Agents. 2009 Dec;34(6):506-15. doi: 10.1016/j.ijantimicag.2009.08.013. Epub 2009 Oct 13.
Parker SL, Frantzeskaki F, Wallis SC, Diakaki C, Giamarellou H, Koulenti D, Karaiskos I, Lipman J, Dimopoulos G, Roberts JA. Population Pharmacokinetics of Fosfomycin in Critically Ill Patients. Antimicrob Agents Chemother. 2015 Oct;59(10):6471-6. doi: 10.1128/AAC.01321-15. Epub 2015 Aug 3.
Gardiner BJ, Mahony AA, Ellis AG, Lawrentschuk N, Bolton DM, Zeglinski PT, Frauman AG, Grayson ML. Is fosfomycin a potential treatment alternative for multidrug-resistant gram-negative prostatitis? Clin Infect Dis. 2014 Feb;58(4):e101-5. doi: 10.1093/cid/cit704. Epub 2013 Oct 28.
Rosso-Fernandez C, Sojo-Dorado J, Barriga A, Lavin-Alconero L, Palacios Z, Lopez-Hernandez I, Merino V, Camean M, Pascual A, Rodriguez-Bano J; FOREST Study Group. Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum beta-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial. BMJ Open. 2015 Mar 31;5(3):e007363. doi: 10.1136/bmjopen-2014-007363.
Grayson ML, Macesic N, Trevillyan J, Ellis AG, Zeglinski PT, Hewitt NH, Gardiner BJ, Frauman AG. Fosfomycin for Treatment of Prostatitis: New Tricks for Old Dogs. Clin Infect Dis. 2015 Oct 1;61(7):1141-3. doi: 10.1093/cid/civ436. Epub 2015 Jun 10.
Los-Arcos I, Pigrau C, Rodriguez-Pardo D, Fernandez-Hidalgo N, Andreu A, Larrosa N, Almirante B. Long-Term Fosfomycin-Tromethamine Oral Therapy for Difficult-To-Treat Chronic Bacterial Prostatitis. Antimicrob Agents Chemother. 2015 Dec 14;60(3):1854-8. doi: 10.1128/AAC.02611-15.
Oteo J, Bautista V, Lara N, Cuevas O, Arroyo M, Fernandez S, Lazaro E, de Abajo FJ, Campos J; Spanish ESBL-EARS-Net Study Group. Parallel increase in community use of fosfomycin and resistance to fosfomycin in extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli. J Antimicrob Chemother. 2010 Nov;65(11):2459-63. doi: 10.1093/jac/dkq346. Epub 2010 Sep 16.
Kyung YS, Lee HC, Kim HJ. Changes in serum prostate-specific antigen after treatment with antibiotics in patients with lower urinary tract symptoms/benign prostatic hyperplasia with prostatitis. Int Neurourol J. 2010 Aug;14(2):100-4. doi: 10.5213/inj.2010.14.2.100. Epub 2010 Aug 31.
Hedelin H, Johansson N, Stroberg P. Relationship between benign prostatic hyperplasia and lower urinary tract symptoms and correlation between prostate volume and serum prostate-specific antigen in clinical routine. Scand J Urol Nephrol. 2005;39(2):154-9. doi: 10.1080/00365590510007685.
Ulleryd P, Sandberg T. Ciprofloxacin for 2 or 4 weeks in the treatment of febrile urinary tract infection in men: a randomized trial with a 1 year follow-up. Scand J Infect Dis. 2003;35(1):34-9. doi: 10.1080/0036554021000026988.
Study Start
January 25, 2022
Actual (reported)Primary Completion
March 18, 2026
Actual (reported)Study Completion
June 30, 2026
Actual (reported)Last Updated
October 28, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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