[Translation] A randomized, open-label, single-dose, two-sequence, two-period, crossover, fasting bioequivalence study of fosfomycin tromethamine granules (3 g) developed by Jiangsu Lianhuan Pharmaceutical Co., Ltd. and fosfomycin tromethamine granules (3 g) produced by Zambon Switzerland Ltd. in healthy Chinese subjects

以江苏联环药业股份有限公司研制的磷霉素氨丁三醇颗粒（规格：3 g）为受试制剂，以Zambon Switzerland Ltd.生产的磷霉素氨丁三醇颗粒（商品名：Monurol®，规格：3 g）为参比制剂，考察两制剂在空腹状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性；同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

Fosfomycin tromethamine granules (specification: 3 g) developed by Jiangsu Lianhuan Pharmaceutical Co., Ltd. were used as the test preparation, and fosfomycin tromethamine granules (trade name: Monurol®, specification: 3 g) produced by Zambon Switzerland Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after a single dose in the fasting state were investigated to evaluate whether the two preparations were bioequivalent; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date21 Aug 2024

Sponsor / Collaborator

Jiangsu Lianhuan Pharmaceutical Co., Ltd.

NCT06017479 / CompletedPhase 1/2

Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic Prophylaxis for Urinary Tract Infection Prevention in Post-Urodynamic Examination

The goal of this clinical trial is to compare the use of single dose fosfomycin and single dose levofloxacin as pre-urodynamic antibiotic prophylaxis for urinary tract infection prevention post-urodynamic in patients with lower urinary tract symptoms. The main question[s] it aims to answer are:
* What is the difference between the effectiveness of administering a single dose of fosfomycin and levofloxacin prior to the procedure in terms of the incidence rate of urinary tract infection (UTI) post-urodynamic examination?
* What is the incidence rate of UTI in the administration of single-dose fosfomycin and levofloxacin prior to the procedure on the incidence rate of UTI post-urodynamic examination? Participants fulfilling the inclusion criteria will be taken their history and vital signs and consume either fosfomycin or levofloxacin based on the randomisation prior to urodynamic procedure. Afterwards, participants will undergo urine analysis 4 days post urodynamic to evaluate if there's any urinary tract infection. If there is any bacteria present, the sample will be cultured to identify bacteria found in the urine.

Start Date30 Dec 2022

Sponsor / Collaborator

University of Indonesia

CTRI/2022/08/045068 / RecruitingPhase 3

A Multicentric, Randomized, Open Label, Controlled, Phase III Clinical Trial to evaluate theEfficacy, Safety and Tolerability of Fosfomycin (Trometamol) Powder 3 g versusCiprofloxacin Tablets 750 mg in patients with Chronic Bacterial Prostatitis and Chronic Pelvic Pain Syndrome

Start Date01 Sep 2022

Sponsor / Collaborator

SRS Pharmaceuticals Pvt Ltd.

100 Clinical Results associated with Fosfomycin Tromethamine

100 Translational Medicine associated with Fosfomycin Tromethamine

100 Patents (Medical) associated with Fosfomycin Tromethamine

260

Literatures (Medical) associated with Fosfomycin Tromethamine

01 Mar 2024·Journal of Hospital Infection

Comparison of different regimens of short-term antibiotic prophylaxis in transrectal prostate biopsy

Article

Author: Krsakova, E ; Fedorko, M ; Cermak, A

BACKGROUNDProstate cancer is the most common malignant solid tumour in men aged >70 years and is the second most common cause of death from oncological circumstances.AIMTo evaluate the effect of different short-term prophylactic antibiotic regimens in transrectal prostate biopsy (PB) on the incidence of infectious complications.METHODSPatients who underwent transrectal ultrasound-guided PB between January 2021 and December 2022 were included in the prospective randomized study. According to the regimen of prophylaxis, patients were randomized into three groups: (1) fosfomycin trometamol 3 g, 3 h before the procedure + ciprofloxacin 500 mg, 2 h before the procedure; (2) fosfomycin trometamol 3 g, 3 h before and 24 h after the procedure; (3) ciprofloxacin 500 mg 12, 2 h before the procedure, and 12 h after the procedure. A rectal swab was performed 1-2 weeks before PB to evaluate the culture findings. Complications were evaluated during follow-up visits within one month after PB.FINDINGSIn the monitored period, 605 PBs were performed, and 544 patients met the inclusion criteria (184, 161, and 199 in groups 1, 2, and 3). Infectious complications occurred in 10 cases (1.83%), namely 3, 4, and 3 according to patient groups. There was no statistically significant difference between the individual groups. None of the patients required hospitalization and all were free of symptoms of sepsis.CONCLUSIONShort-term antibiotic prophylaxis in PB using fosfomycin trometamol, ciprofloxacin, or their combination appears to be effective. Fosfomycin trometamol is a suitable alternative to fluoroquinolone antibiotics.

27 Dec 2023·Urologiia

Optimization of prevention of infectious complications during prostate biopsy

Review

Author: Pushkar D, Yu ; Kolontarev K, B ; Stroganov R, V

Prostate cancer (PCa) is one of the most common malignant neoplasms in middle-aged and elderly men. Transrectal ultrasound guided prostate biopsy is the standard method for diagnosing prostate cancer but is associated with a high incidence of infectious compli-cations. A review of the literature on optimizing the prevention of infectious complications when performing transrectal prostate biopsy is presented. The main risk factors and the common measures to prevent the development of complications are discussed, including a study of using fosfomycin trometamol as the preferred drug for antibacterial prophylaxis. Fosfomycin meets the requirements for empirical prophylaxis, but further clinical studies are needed.

01 Dec 2023·International Journal of Antimicrobial Agents

Rediscovering the value of fosfomycin trometamol in the era of antimicrobial resistance: A systematic review and expert opinion

Review

Author: Stefani, Stefania ; Novelli, Andrea ; Tascini, Carlo ; Cai, Tommaso

The worldwide prevalence of uncomplicated lower urinary tract infections (uUTIs) caused by multidrug-resistant Escherichia coli is increasing. To address this emergency, international guidelines recommend reducing administration of fluoroquinolones, in the context of growing resistance and the long-lasting and potentially disabling side effects of these drugs. The favoured drug to replace fluoroquinolones is fosfomycin trometamol (FT), a well-known derivate of phosphonic acid with broad-spectrum activity against Gram-negative and Gram-positive bacteria, including multidrug-resistant (MDR) strains. The European Committee on Antimicrobial Susceptibility Testing (EUCAST) recently reduced the susceptibility breakpoint for E. coli from 32 mg/L to 8 mg/L regarding FT used for uUTIs. This might lead to increased appropriate use of oral fosfomycin target therapy against E. coli and other microorganisms, and may be associated with a high likelihood of success. For species such as Klebsiella spp, particularly MDR strains, the absence of clinical breakpoints might lead to reduced use of oral fosfomycin, particularly if minimum inhibitory concentration is not available. To address this issue, this review presents an overview of the preclinical evidence on the activity of FT, and a systematic review of the clinical activity of FT in uUTIs in women, and in the prevention of infectious complications after prostate biopsy. The findings indicate that the safety and microbiological and clinical effectiveness of a single oral dose of FT are similar to that for comparator regimens with longer treatment schedules in women with uUTI, and FT can be considered a viable alternative to fluoroquinolones for antimicrobial prophylaxis in prostate biopsy. These observations and a broad clinical experience support the empirical use of FT for treating uUTI and indicate that FT is a promising candidate to effectively counteract antibiotic-resistant uUTIs throughout Europe.

News (Medical) associated with Fosfomycin Tromethamine

19 Jul 2024

·firstwordpharma.com

Meitheal taps Nabriva’s antibiotic Contepo, hoping third time lucky with the FDA

Meitheal Pharmaceuticals has secured North America rights to Nabriva Therapeutics’ intravenous broad-spectrum antibiotic Contepo (fosfomycin for injection), which has been stuck in regulatory limbo in the US since 2020. However, an FDA decision on the injectable for treating complicated urinary tract infections (cUTIs) is expected later this year. Dubbing it a “novel therapeutic with the potential to address a significant unmet need around increasing antibiotic resistance,” Tom Shea, chief executive of Meitheal, said the company is “uniquely positioned to advance Contepo through the final stages of the regulatory process and…deliver a…high-quality antibiotic to patients and providers.”As part of the deal, Meitheal gains licensing rights and all associated intellectual property, technology and know-how for Contepo, while Nabriva stands to receive an undisclosed payment at closing and royalties on US sales.While the oral form of fosfomycin – marketed as Monurol in the US by AbbVie – was cleared by the FDA in 1997 to treat uncomplicated UTIs in women, Nabriva’s injectable version has been rejected twice by the US regulator in 2019 and 2020. Both complete response letters cited deficiencies related to facility inspections and manufacturing processes at contract manufacturing sites in Europe.With this acquisition, Meitheal has added a second asset to its specialty portfolio, after bagging North America rights to Xentria’s anti-TNFα antibody XTMAB-16 last year. Meitheal’s buyouts align with the broader vision of its parent company Nanjing King-Friend Biochemical Pharmaceutical to focus on branded biopharmaceuticals.

Drug ApprovalAcquisitionLicense out/in

100 Deals associated with Fosfomycin Tromethamine

External Link

KEGG	Wiki	ATC	Drug Bank
D00925	Fosfomycin Tromethamine	J01XX01	DBSALT000781

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Urinary Tract Infections	-	Zambon GmbH	01 Jan 1988

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06017479 (CTgov)	Phase 1/2	Urinary Tract Infections \| Postoperative Complications	126	Fosfomycin 3000 MG (Pre-urodynamic Fosfomycin)	knptfiqxvr(svrkpqtftg): Odds Ratio (OR) = 0.8 (95% CI, 0.4 - 1.95), P-Value = 0.660	-	09 Oct 2024
				Levofloxacin 500mg (Pre-urodynamic Levofloxacin)
NCT03697993 (CTgov)	Phase 4	Urinary Tract Infections	62	Fosfomycin tromethamine (Strategy 1)	qocsoknmnj(xxkxgjdeua) = vumlkcjyuq dsorxzjxjw (hrxrcjdsgt, pgwinjrwcu - pgsetlixxc) View more	-	19 Dec 2020
				Levofloxacin (Strategy 2)	qocsoknmnj(xxkxgjdeua) = ozkkhnkozc dsorxzjxjw (hrxrcjdsgt, kcvzxwshnq - ngjkwypesg) View more
NCT02132468 (GI-NETorPNET, CTgov)	Phase 2	Carcinoid Tumor	18	fosbretabulin tromethamine	arworwvlsq(tumfedsipg) = rsfddqsiqo oxivwkzvyn (pupdoaewwm, zubdprnagj - hlfamqsvbr) View more	-	19 Oct 2017

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