The Open Microbiology Journal




ISSN: 1874-2858 ― Volume 13, 2019
SYSTEMATIC REVIEW

Single-Dose Fosfomycin Trometamol Versus Other Antimicrobial Regimens For Treatment Of Uncomplicated Lower Urinary Tract Infection: A Systematic Review And Meta-Analysis



Mubarak Alfaresi*, Kawther Hassan, Rafi M.H. Alnjadat
College of Medicine, University of Sharjah, Sharjah, UAE

Abstract

Objectives:

Uncomplicated Lower Urinary Tract Infections (LUTIs) are the most common source of infection affecting women. The increasing prevalence of antimicrobial resistance to commonly prescribed antibiotics has led to the development and use of novel therapies. This current meta-analysis and systematic review evaluate the use of single-dose Fosfomycin-Trometamol (FMT) versus alternative antimicrobial regimens in the management of uncomplicated LUTI.

Methods:

This is a systematic review. We included observational studies and Randomized Controlled Trials (RCTs). Studies that investigated the efficacy of fosfomycin or FMT in managing uncomplicated LUTIs in any age group or gender and compared the treatment to any alternative antibiotic regimen were considered eligible.

Results:

After a comprehensive review of the literature, nineteen studies fulfilled the inclusion criteria. All of the eligible studies (3779 patients) investigated showed no difference between the use of single-dose fosfomycin versus alternative antibiotic regimens for LUTI treatment (OR, 1.003; 95% CI, 0.853-1.181; p = 0.967). The OR remained unchanged but became statistically significant when the random-effects model was used for sensitivity analysis (OR, 1.53; 95% CI, 1.05-2.38; p = 0.04).

Conclusion:

The meta-analysis revealed that there was no significant difference between single-dose FMT and the commonly prescribed antibiotic regimens in LUTI treatment outcomes such as clinical improvement and microbial eradication.

Keywords: Fosfomycin trometamol, Antimicrobial, Lower urinary tract infection, Single-dose FMT, Antimicrobial regimens, Random-effects model.


Article Information


Identifiers and Pagination:

Year: 2019
Volume: 13
First Page: 193
Last Page: 199
Publisher Id: TOMICROJ-13-193
DOI: 10.2174/1874285801913010193

Article History:

Received Date: 01/01/2019
Revision Received Date: 06/05/2019
Acceptance Date: 13/05/2019
Electronic publication date: 30/06/2019
Collection year: 2019

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© 2019 Alfaresi et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


* Address correspondence to this author at the College of Medicine, University of Sharjah, Sharjah, UAE; Tel: +971504411755; Email: uaenow@eim.ae




1. INTRODUCTION

Urinary Tract Infections (UTIs) are one of the most frequently encountered bacterial infections in women [1Bacheller CD, Bernstein JM, Beinsten MJ. Urinary tract infections. Med Clin North Am 1997; 81(3): 719-30.[http://dx.doi.org/10.1016/S0025-7125(05)70542-3] [PMID: 9167654] -4Naber KG, Bergman B, Bishop MC, et al. EAU guidelines for the management of urinary and male genital tract infections. Eur Urol 2001; 40(5): 576-88.[http://dx.doi.org/10.1159/000049840] [PMID: 11752870] ], and most commonly present as an acute uncomplicated UTI, relegated to the lower urinary tract. Up to 20-30% of adult women will experience at least one UTIs each year [1Bacheller CD, Bernstein JM, Beinsten MJ. Urinary tract infections. Med Clin North Am 1997; 81(3): 719-30.[http://dx.doi.org/10.1016/S0025-7125(05)70542-3] [PMID: 9167654] ]. While there are multiple urinary pathogens responsible for UTIs in women, the most common causative microorganism is Escherichia coli (E. coli), which is the etiological agent in 70–90% of all bacterial LUTIs [2Sobel DJ, Kaye D. Urinary tract infections.Principles and practice of infectious disease 6th ed. 6th ed.2005; 875-905.-5Hooton TM. The epidemiology of urinary tract infection and the concept of significant bacteriuria. Infection 1990; 18(S2)(Suppl. 2): S40-3.[http://dx.doi.org/10.1007/BF01643424] [PMID: 2286458] ]. A range of antibiotics with varied dosing, frequencies and durations have been used to treat uncomplicated UTIs. Although a 7-to-10-day treatment regimen has been the standard practice historically, there is an increasing interest in the use of short-term regimens of 1-3 days. Such regimens are reported to have similar efficacy rates as longer courses with the added benefits of improving patient compliance and reducing adverse events associated with the long term exposure to antimicrobial medications.

The prevalence of antibacterial resistance to antibiotics commonly prescribed for LUTIs varies across countries. These resistance rates are, at least partially, related to the increasingly widespread use of antibiotics [6Naber KG, Schito G, Botto H, Palou J, Mazzei T. Surveillance study in Europe and Brazil on clinical aspects and Antimicrobial Resistance Epidemiology in Females with Cystitis (ARESC): Implications for empiric therapy. Eur Urol 2008; 54(5): 1164-75.[http://dx.doi.org/10.1016/j.eururo.2008.05.010] [PMID: 18511178] , 8Palou J, Pigrau C, Molina I, Ledesma JM, Angulo J. Etiology and sensitivity of uropathogens identified in uncomplicated lower urinary tract infections in women (ARESC Study): Implications on empiric therapy. Med Clin (Barc) 2011; 136(1): 1-7.[http://dx.doi.org/10.1016/j.medcli.2010.02.042] [PMID: 20889171] -11Gupta K, Scholes D, Stamm WE. Increasing prevalence of antimicrobial resistance among uropathogens causing acute uncomplicated cystitis in women. JAMA 1999; 281(8): 736-8.[http://dx.doi.org/10.1001/jama.281.8.736] [PMID: 1005 2444] ]. The resistance of E. coli and other uropathogens to antimicrobials such as Sulfamethoxazole-Trimethoprim (SXT), ampicillin and the quinolones, have gradually increased in the United Arab Emirates [12Hooton TM. Fluoroquinolones and resistance in the treatment of uncomplicated urinary tract infection. Int J Antimicrob Agents 2003; 22(Suppl. 2): 65-72.[http://dx.doi.org/10.1016/S0924-8579(03)00238-3] [PMID: 14527774] -17Schito GC. Why fosfomycin trometamol as first line therapy for uncomplicated UTI? Int J Antimicrob Agents 2003; 22(Suppl. 2): 79-83.[http://dx.doi.org/10.1016/S0924-8579(03)00231-0] [PMID: 1452 7776] ]. Therefore, novel antibiotics with dosing regimens that are easy to comply with and do not share similar resistance mechanisms to currently available antibiotics are needed. Fosfomycin-trometamol (FMT) is a phosphonic acid derivative that is reported to be as efficacious as other commonly used antimicrobials for the treatment of uncomplicated LUTIs when prescribed as a single three gram dose [18Warren JW, Abrutyn E, Hebel JR, Johnson JR, Schaeffer AJ, Stamm WE. Guidelines for antimicrobial treatment of uncomplicated acute bacterial cystitis and acute pyelonephritis in women. Clin Infect Dis 1999; 29(4): 745-58.[http://dx.doi.org/10.1086/520427] [PMID: 10589881] , 19Stein GE. Fosfomycin tromethamine: Single-dose treatment of acute cystitis. Int J Fertil Womens Med 1999; 44(2): 104-9.[PMID: 10338268] , 21Naber KG, Thyroff-Friesinger U. Fosfomycin trometamol versus ofloxacin/co-trimoxazole as single dose therapy of acute uncomplicated urinary tract infection in females: a multicenter study. Infection 1990; 18: 7-6.[http://dx.doi.org/10.1007/BF01643431] -24Wells G, Shea B, O’Connell D, et al. The Newcastle-Ottawa Scale (NOS) for Assessing the Quality of Non-randomized Studies in Meta-Analysis. Ottawa, Ontario, The Ottawa Health Research Institute. Available at: http://www.ohri.ca/programs/clinical_epidemiology/nosgen.pdf [Accessed November 5, 2014];].

A single-dose of FMT provides benefits over antibiotics with multiple dose regimens due to its minimal side-effects and excellent safety profile when prescribed to children and pregnant women [23Krcmery S, Hromec J, Demesova D. Treatment of lower urinary tract infection in pregnancy. Int J Antimicrob Agents 2001; 17(4): 279-82.[http://dx.doi.org/10.1016/S0924-8579(00)00351-4] [PMID: 11295408] -29Souli M, Galani I, Antoniadou A, et al. An outbreak of infection due to beta-Lactamase Klebsiella pneumoniae Carbapenemase 2-producing K. pneumoniae in a Greek University Hospital: Molecular characterization, epidemiology, and outcomes. Clin Infect Dis 2010; 50(3): 364-73.[http://dx.doi.org/10.1086/649865] [PMID: 20041768] ].

The goal of this systematic review is to evaluate the clinical and microbial efficacy of single-dose FMT versus traditional antimicrobial regimens in a diverse group of patients presenting with uncomplicated LUTIs.

2. MATERIALS AND METHODS

2.1. Search Strategy

We completed a comprehensive systematic review via MEDLINE and the Cochrane Library, with no restrictions based on language or year of publication. The search string used was: (fosfomycin OR fosfomycin trometamol) and urine. The final search occurred in June 2018. Additional articles relevant to the study were manually obtained by reviewing the reference lists of eligible bibliographies and the reference section of selected manuscripts was investigated to make sure that all publications relevant to the topic were utilized.

2.2. Study Selection

Studies that investigated the efficacy of fosfomycin or FMT in managing uncomplicated LUTIs in any age group or gender and compared the treatment to any alternative antibiotic regimen were considered eligible. Studies were eligible for inclusion into the meta-analysis if they evaluated single-dose fosfomycin or FMT as monotherapy in comparison to other antimicrobials. Studies that did not report clinical or bacterial culture outcomes were excluded from the analysis. In addition, studies without an English translation or publically available full text were also excluded.

2.3. Data Extraction and Quality Assessment

Two reviewers (M.A and K.I.) independently evaluated the data using a predetermined screening form. If a disagreement in study eligibility arose, the reviewers re-assessed the data until consensus was reached. We extracted the following data from each study: the primary author’s last name, year of publication, country in which the study took place, study type (retrospective/prospective, cohort/case-control/randomised), matching criteria (for case-control studies), authors’ definition of uncomplicated LUTI, fosfomycin dose, type and dose of alternate antimicrobials, therapy length, etiological microorganism(s), comorbid patient conditions and defining outcomes (clinical and microbiological).

Each study was independently assessed by the investigators to determine methodological quality for cohort or case control studies and randomized studies, using the Newcastle-Ottawa Quality Assessment Scale [12Hooton TM. Fluoroquinolones and resistance in the treatment of uncomplicated urinary tract infection. Int J Antimicrob Agents 2003; 22(Suppl. 2): 65-72.[http://dx.doi.org/10.1016/S0924-8579(03)00238-3] [PMID: 14527774] ] and the Cochrane risk-of-bias tool assessment [13Goettsch W, van Pelt W, Nagelkerke N, et al. Increasing resistance to fluoroquinolones in escherichia coli from urinary tract infections in the netherlands. J Antimicrob Chemother 2000; 46(2): 223-8.[http://dx.doi.org/10.1093/jac/46.2.223] [PMID: 10933644] ], respectively.

2.4. Outcome Measures

The main outcome measurement was the clinical success rate, defined as clinical cure or improvement (complete and partial resolution, respectively) of the signs and symptoms of LUTI at the termination of the prescribed antimicrobial regimen.

The secondary outcome measures were infection-related mortality, overall mortality, nephrotoxicity and eradication of the microbial organisms, which were defined as undetectable growth of the etiological agent at the end of the prescribed antimicrobial regimen, irrespective of the clinical outcome.

2.5. Data Synthesis and Analysis

The pooled effect estimates and their 95% Confidence Interval (CI) were determined only when two or more studies with sufficient data were available for each outcome of interest. The overall effect estimate for all dichotomous data with 95% CI was calculated as the Odds Ratio (OR). The presence of statistical heterogeneity among the studies and the magnitude of heterogeneity were addressed by utilizing Q and I2 statistics, respectively. A p value less than 0.10 or an I2 value greater than 50% was determined to signify substantial heterogeneity. In the cases that substantial heterogeneity was observed and not observed, pooled OR was calculated by the random-effects and fixed-effects models, respectively. We used Comprehensive Meta-Analysis version 3.3.070 for all calculations.

The exclusion criteria were conducted based on sensitivity analysis and were determined by recalculating pooled OR estimates for each study subgroups based on the relevant clinical characteristics. This analysis indicates if the overall results were affected by changing the selection criteria for meta-analysis. As the eligible studies were clinically heterogeneous, we performed sensitivity analysis on all outcomes by the utilizing random-effects model regardless of the estimate of statistical heterogeneity.

3. RESULTS

3.1. Searching Results

The systemic review identified 114 relevant records, of which 38 full-text manuscripts were determined to be potentially eligible. Only 19 of these articles met the full inclusion criteria for our study. Fig. (1).

3.2. Meta-Analysis and Quality Assessment of the Eligible Studies

Among the 19 studies included in our analysis (see Table 1), 18 compared the use of single-dose fosfomycin versus alternate antibiotics while one study compared two doses of fosfomycin with alternate antibiotics. Seventeen of the studies used the same definition of uncomplicated LUTI. A single study used acute UTI as the defining illness.

Fig. (1)
Flowchart of study design and articles selection.


The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence profile was used to assess the quality of evidence for each outcome in the meta-analysis. The GRADE results did not reveal any limitations in the study design or inconsistency in the majority of outcomes of the studies evaluated. There was no observed indirectness or imprecision in the reporting of results. Based on these assessments, we considered the quality of evidence for each outcome to be moderate.

3.3. Systematic Review of the Eligible Studies

Sixteen of the eligible studies used a single-blinded design, while the remainder used a randomised double-blinded design. Eight studies reported on both the clinical and microbiological outcomes, while 11 studies only reported on microbiological outcomes. Of the 19 eligible studies, four compared fosfomycin to norfloxacin, three compared it to trimethoprim, two each compared it to ciprofloxacin, nitrofurantoin, amoxicillin-clavulanate and pipemidic acid and one each compared it to cephalexin, pefloxacin, netilmicin and cephalexin. The quality of evidence was considered moderate based on the GRADE approach.

3.4. Clinical Outcome: Clinical Response with Single-dose Fosfomycin Versus Alternate Antibiotic Regimens

Eight studies, consisting of 2886 patients, evaluated the clinical response of patients with LUTI who received single-dose fosfomycin treatment in comparison with patients who received alternate antimicrobial regimens. Consistency in the definition of clinical response was observed among all eligible studies.

A non-statistically significant improvement in clinical outcomes was found when alternative antibiotic regimens were compared to single-dose fosfomycin (OR, 0.957; 95% CI, 0.717-1.276; p = 0.764). This result indicates that there was no difference between the two groups (Fig. 2). The quality of evidence for this outcome was considered moderate based on the GRADE approach. The OR remained unchanged but statistically significant when the random-effects model was used for sensitivity analysis (OR, 1.53; 95% CI, 1.05–2.38; p = 0.04).

3.5. Microbiological Outcome: Microbiological Eradication with Single-dose Fosfomycin Versus Alternate Antibiotic Regimens

All of the eligible studies (3779 patients) evaluated data on the microbiological eradication of single-dose fosfomycin compared to alternative antibiotic regimens. There was consistency across the included studies in the definition of clinical success.

A non-statistically significant improvement in clinical response was found when single-dose fosfomycin was compared to alternate antibiotic regimens (OR, 1.026; 95% CI, 1.250-0.798; p = 0.798). This result indicates that there was no difference between the two groups (Fig. 2). According to the GRADE approach, the quality of evidence for this outcome was moderate. The OR remained unchanged but became statistically significant when the random-effects model was used to determine sensitivity analysis (OR, 1.53; 95% CI, 1.05-2.38; p = 0.04).

Table 1
Summary of all eligible studies.


Fig. (2)
Forest plot of Clinical outcome, Microbiological outcome and over all outcome between patients received single dose fosfomycin and those who received other antibiotic regimen for LUTI treatment.


3.6. Overall Outcome: Single-dose Fosfomycin Versus Alternate Antibiotic Regimens for LUTI Treatment

All of the eligible studies (3779 patients) investigated showed no difference between the use of single-dose fosfomycin versus alternative antibiotic regimens for LUTI treatment (OR, 1.003; 95% CI, 0.853-1.181; p = 0.967). The OR remained unchanged but became statistically significant when the random-effects model was used for sensitivity analysis (OR, 1.53; 95% CI, 1.05-2.38; p = 0.04).

4. DISCUSSION

The optimal antimicrobial treatment duration for uncomplicated LUTI depends on a host of factors. Short (1–3 days) courses of therapy appear to be the most effective in young, non-pregnant women who present with symptoms lasting less than 7 days and who do not have a recent history of failed treatment. Interestingly, short courses of therapy are associated with worse outcomes in uncomplicated LUTIs caused by Staphylococcus saprophyticus, the second most common bacteria found in young women presenting with UTIs.

Single-dose regimens are not the standard of care as many antimicrobials, especially the beta-lactam group, have reduced efficacy when prescribed as a single dose, even in the case of supratherapeutic doses [14Kahlmeter G. Prevalence and antimicrobial susceptibility of pathogens in uncomplicated cystitis in Europe. The ECO.SENS study. Int J Antimicrob Agents 2003; 22(Suppl. 2): 49-52.[http://dx.doi.org/10.1016/S0924-8579(03)00229-2] [PMID: 1452 7771] ]. Furthermore, UTI symptoms often persist beyond a single day of treatment, which may produce anxiety in patients who fear that their antimicrobial treatment course is inadequate.

FMT is a unique antibiotic in that it is an effective single-dose therapy in women age 18 years and older with acute uncomplicated LUTI [16Kahlmeter G. The ECO.SENS Project: A prospective, multinational, multicentre epidemiological survey of the prevalence and antimicrobial susceptibility of urinary tract pathogens-interim report. J Antimicrob Chemother 2000; 46(Suppl. 1): 15-22.[http://dx.doi.org/10.1093/jac/46.suppl_1.15] ]. Results of small clinical trials indicate that clinical cure and microbial eradication with FMT is equivalent to comparable antibiotic agents, such as norfloxacin and STX when administered for periods of 1, 3, 5 or 7 days.

The present study is a systematic review and meta-analysis that primarily examines the role of single-dose fosfomycin in the management of LUTIs. Our findings indicate that there is no significant difference between single-dose fosfomycin and alternate antibiotic regimens for the treatment of LUTI related outcomes, including clinical cure, improvement and microbiological eradication.

CONCLUSION

This meta-analysis suggests that single-dose fosfomycin is an effective treatment modality for uncomplicated LUTI.

CONSENT FOR PUBLICATION

Not applicable.

STANDARD FOR REPORTING

PRISMA guidelines and methodology were followed.

AVAILABILITY OF DATA AND MATERIALS

Not applicable.

FUNDING

None.

CONFLICT OF INTEREST

The authors declare no conflict of interest, financial or otherwise.

ACKNOWLEDGEMENTS

We would like to extend our thanks to the Medical College, University of Sharjah for UAE supporting this study.

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Endorsements



"Open access will revolutionize 21st century knowledge work and accelerate the diffusion of ideas and evidence that support just in time learning and the evolution of thinking in a number of disciplines."


Daniel Pesut
(Indiana University School of Nursing, USA)

"It is important that students and researchers from all over the world can have easy access to relevant, high-standard and timely scientific information. This is exactly what Open Access Journals provide and this is the reason why I support this endeavor."


Jacques Descotes
(Centre Antipoison-Centre de Pharmacovigilance, France)

"Publishing research articles is the key for future scientific progress. Open Access publishing is therefore of utmost importance for wider dissemination of information, and will help serving the best interest of the scientific community."


Patrice Talaga
(UCB S.A., Belgium)

"Open access journals are a novel concept in the medical literature. They offer accessible information to a wide variety of individuals, including physicians, medical students, clinical investigators, and the general public. They are an outstanding source of medical and scientific information."


Jeffrey M. Weinberg
(St. Luke's-Roosevelt Hospital Center, USA)

"Open access journals are extremely useful for graduate students, investigators and all other interested persons to read important scientific articles and subscribe scientific journals. Indeed, the research articles span a wide range of area and of high quality. This is specially a must for researchers belonging to institutions with limited library facility and funding to subscribe scientific journals."


Debomoy K. Lahiri
(Indiana University School of Medicine, USA)

"Open access journals represent a major break-through in publishing. They provide easy access to the latest research on a wide variety of issues. Relevant and timely articles are made available in a fraction of the time taken by more conventional publishers. Articles are of uniformly high quality and written by the world's leading authorities."


Robert Looney
(Naval Postgraduate School, USA)

"Open access journals have transformed the way scientific data is published and disseminated: particularly, whilst ensuring a high quality standard and transparency in the editorial process, they have increased the access to the scientific literature by those researchers that have limited library support or that are working on small budgets."


Richard Reithinger
(Westat, USA)

"Not only do open access journals greatly improve the access to high quality information for scientists in the developing world, it also provides extra exposure for our papers."


J. Ferwerda
(University of Oxford, UK)

"Open Access 'Chemistry' Journals allow the dissemination of knowledge at your finger tips without paying for the scientific content."


Sean L. Kitson
(Almac Sciences, Northern Ireland)

"In principle, all scientific journals should have open access, as should be science itself. Open access journals are very helpful for students, researchers and the general public including people from institutions which do not have library or cannot afford to subscribe scientific journals. The articles are high standard and cover a wide area."


Hubert Wolterbeek
(Delft University of Technology, The Netherlands)

"The widest possible diffusion of information is critical for the advancement of science. In this perspective, open access journals are instrumental in fostering researches and achievements."


Alessandro Laviano
(Sapienza - University of Rome, Italy)

"Open access journals are very useful for all scientists as they can have quick information in the different fields of science."


Philippe Hernigou
(Paris University, France)

"There are many scientists who can not afford the rather expensive subscriptions to scientific journals. Open access journals offer a good alternative for free access to good quality scientific information."


Fidel Toldrá
(Instituto de Agroquimica y Tecnologia de Alimentos, Spain)

"Open access journals have become a fundamental tool for students, researchers, patients and the general public. Many people from institutions which do not have library or cannot afford to subscribe scientific journals benefit of them on a daily basis. The articles are among the best and cover most scientific areas."


M. Bendandi
(University Clinic of Navarre, Spain)

"These journals provide researchers with a platform for rapid, open access scientific communication. The articles are of high quality and broad scope."


Peter Chiba
(University of Vienna, Austria)

"Open access journals are probably one of the most important contributions to promote and diffuse science worldwide."


Jaime Sampaio
(University of Trás-os-Montes e Alto Douro, Portugal)

"Open access journals make up a new and rather revolutionary way to scientific publication. This option opens several quite interesting possibilities to disseminate openly and freely new knowledge and even to facilitate interpersonal communication among scientists."


Eduardo A. Castro
(INIFTA, Argentina)

"Open access journals are freely available online throughout the world, for you to read, download, copy, distribute, and use. The articles published in the open access journals are high quality and cover a wide range of fields."


Kenji Hashimoto
(Chiba University, Japan)

"Open Access journals offer an innovative and efficient way of publication for academics and professionals in a wide range of disciplines. The papers published are of high quality after rigorous peer review and they are Indexed in: major international databases. I read Open Access journals to keep abreast of the recent development in my field of study."


Daniel Shek
(Chinese University of Hong Kong, Hong Kong)

"It is a modern trend for publishers to establish open access journals. Researchers, faculty members, and students will be greatly benefited by the new journals of Bentham Science Publishers Ltd. in this category."


Jih Ru Hwu
(National Central University, Taiwan)


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