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Invasive devices such as catheters are the leading causes of infection in healthcare fa­ciliti­es. And there is one type of catheter that is responsible for more healthcare-associated infections (HAIs) in hospitals, long term care and home care than any other device – the indwe­lling urinary catheter. Indewelling catheter is a drainage tube that is inserted int­o the urinary bladder through the urethra is left in place, and it is connected to a closed collection system, e.g., not used for irrigation also called a Foley catheter, does not include straight in-and-out catheters.

 Catheter-associated UTI (CAUTI) can lead to such complications as cystitis, pyelonephritis, gram-negative bacteriemia, prostatitis, epididymitis and orchitis in males and less, com­monly, endocarditis, vertebral osteomye­litis, septic arthritis, endophthalmitis and neningitis in all patients. Complications associated with CAUTI cause discomfort to the patient, prolonged hospital stays by 1 to 3 days, and increased to overall patient cost , especially if bacteriemia occurs and also increased mortality. Each year, more than 13,000 deaths are associated with UTIs.40,41,42

 

Here are the facts:

More than 1 million cases of CAUTI occur each year in U.S. hospitals and nursing homes and CAUTIs account for up to 40% of HAIs. It is estimated that 25% of patient in the acute care settting will have an indwelling catheter at some point in their hospitalization, and 69% of patients in medical ICUs hospitalized in NNIS hospitals from 1992-1997 had urinary catheters.

Prevention of CAUTI is discussed in the CDC/HICPAC document, Guideline for prevention of Catheter-associaed Urinary Tract Infections.

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Alternative Names

UTI-catheter associated; Urinary tract infecti­on - catheter associated; Nosocomial UTI; Health care associated UTI; Catheter-associat­ed bacteriuria .

 

Definition

Catheter-related urinary tract infection (UTI) is an infection that occurs in someone who has a tube (called a catheter) in place to drain urine from the body.

 

Causes, Incidence, and Risk Factors

Having a catheter within the urinary tract your chances of an urinary tract infection. It may also make it harder to treat the infection.

If a urinary catheter is left in place for a long time, bacteria will grow in it. A harmful infection may occur if the number of bacteria becomes large or if specific harmful bacteria grow in the urinary tract.

Most catheter-associated UTIs are caused by bacteria. However, the fungus Candida may cause infections of the urinary tract.

Catheterization is accomplished by inserting a catheter (a hollow tube, often with and inflatable balloon tip) into the urinary bladder. This procedure is performed for urinary obstruc­tion, following surgical procedures to the urethra, in unconscious patients (due to surgical anesthesia, coma, etc.), or for any other problem in which the bladder needs to be kept empty (decompressed) and urinary flow assured. Catheterization in males is slightl­y more difficult and uncomfortable than in females because of the longer urethra.

Symptoms

 Abnormal urine color (cloudy urine), blood in the urine, foul or strong urine odor, frequent  urge to urinate, leakage of urine around the catheter, pressure in the lower abdomen or pelvis.

Other symptoms that may occur are: chills, fatigue, fever, flank pain, mental changes or confusion (are the only signs of a possible UTI often in an elderly person), and vomiting.

Urine tests are done to check for infection: Urinalysis may show white blood cells (WBCs) or red blood cells (RBCs). Urine culture can help determine the type of bacteria in the urine and the appropriate antibiotic treatment. 40% of all hospital-acquired infec­ti­on­s are in the majority of cases, catheter-assoc­iated. Bacteruria develops in up to 25% of patients who require a urinary catheter for = 7 days, with a daily risk of 5%. A single inserti­on of a catheter into the urinary bladde­r in ambulatory patients results in urinar­y infections in 1-2% of cases. Indwelling catheters with open-drainage system­s results in bacteriuria in almost 100% cases within 3-4 days. The use of a closed-drainage system, including a valve to prevent retrograde flow, delays the onsets of infection, but ultimately does not prevent it.It is thought that bacteria migrate within the mucopurulent space between the urethra and catheter, and that this leads to the development bacteriuria in almost all patients within about 4 weeks.2

 There are three possible ways by which bacteria can invade and spread within the urinary tract: the ascent of microorganisms from the urethra, haematogenous and lymphatic routes.2,7,8,9,10 This a logic explanation if the frequency of UTI is more frequently in women compared to men and increase the risk of infecti­on after catheterization of the bladder and instrumentation.

In Stroke patients the lower UTIs or cystitis is mostly happened after the use indwell­ing catheter with open-drainage system result in bacteriuria in almost 100% of cases within 3-4 days. The bacteria migrate/ ascend within the mucopurulent space between the urethr­a and catheter, and this leads to the developm­ent of bacteriuria.

The change of resistance pattern had been found in the most uropathogens caused changes of empirically approach for selection antimicrobial for lower or upper UTI. Previously, the decision about antimicrobial therapy is based on the characteristic of patien­t and flora spectrum of urinary tract. But with the increased of resistance to Trimethoprim (TMP) or TMP-sulphamethoxazole (TMP-SMX), beta-lactams penicillin and fluoroquinolones in the last decade in all over the world caused the decreased usage of these drugs for treatment of UTI. The direction of therapy has changed to use short courses of antimicrobial. In general, both guidelines on UTI by IDSA (Infectious Disease Society of America)- ESMID (European Society Microbiology Infectious Diseases) 2011 and EAU (European Association of Urology) Update March 2011 agreed that aims of treatment are rapid disappearance of clinical symptoms, reduction of morbidities due to relaps­es or reinfection and prophylaxis of reinfect­ions can be satisfactorily realized by short-term antibiotic therapy.1,2,3,4,36 Short-course regimens or single-dose therapy are desirable because better compliance that they promote, their lower cost of therapy, fewer side effects, and lower selection of resistan­ce pathogen.1,2,3,4,11,16,36

The survey found that the urinary tract is the commonest source of nosocomial infection, particularly when the bladder is catheterized (LE:2a). Most CAUTIs are derived from the patient’s own colonic flora (LE;2b) and the catheter predisposes to UTI in severa­l ways. The most important risk factor for the development of catheter-associated bacter­iuria is the duration of catheterization (LE:2a). Most episodes of short-term catheter-associat­ed bacteriuria are asymptomatic and caused by a single organism (LE:2a). Further organisms tend to be acquired by patients who are catheterization for more than 30 days.

The clinician should be aware of two priorit­ies: the catheter system should remain closed and the duration of catheterisation should be minimal (GR:A). The use of nurse-based or electronic reminder systems to remove unnecessary catheters can decrease the duration of cathetherization and and the risk of CAUTI (LE:2a). The drainage bag should be always kept below the level of bladder and the connecting tube  (GR:B).

Antibiotic treatment is recommended only for symptomatic infection (GR: B). Patient with urethral catheters in place for 10 years or more should be screened for bladder  cancer (GR:C).2,4,34

Commonly used antibiotics include Fosfomycin tromethamole; Cephalosporins (i.e. ceftriaxone or cefepime); Fluroquino­lones (ciprofloxacin or levaquin); Penicillins (amoxicillin). Medications to relax the bladder spasms (anticholinergics) may also be given. Phenazopyridine hydrochloride (Pyridium) may be used to reduce burning and urinary urgency. 

Chronic in-body catheter (Foley or suprapubic tube) should be changed every month. Proper sterile techniques must be used. Increasing the amount of fluids to 2000-4000 cc per day increases urine low. This flushes bacteria from bladder. Avoid fluids that irritate the bladder, such as alcohol, citrus juices and caffeine.

On average, each episode of this type of UTI in young women was shown to be associated with 6.1 days of symptoms, 2.4 days of restricted activity, 1.2 days in which they were not able to attend classes or work and 0.4 days in bed. The effect on the quality of life is quite high and unconvenience.1,2,3,4,,7,8,,9,10,13

 The frequency of UTIs is varies according to gender and age, the trend is becoming higher on women and reaching the peak incide­nce after started the sexual activity, pregnancy period, and after menopause. The exception of gender can be observed in the boy under a year of age because of urinary tract malformation, like posterior urethra valve or vesicoureteral reflux and others and in the eldery men due to prostate enlargement will cause an obstruction of urinary tract. Because of the ascending infection, shorter urethra length in women and the nearness of anus and urethra makes infection easier in the women. Migration of microorganism to peri-urethra area, vagina colonization, vestibule, and distal urethra which can be modified by hormone especially estrogen, are pre-requisite steps for further migration into urinary bladder. Bacterial implantation int­o uro-ephitelium was the main factor of pathogenesis.

Type 1 pili/fimbria from several strain of E.coli is always related with UTIs containing the adhesiveness FimH molecule that specifically bonded with receptor on uroepithelium. Other virulence factor of E. coli such as uroepithe­lial adherence, biofilm, alpha hemolicy­n, cytolysin A, cytotoxic necrotizing factor, FE liberating, FE scavenger, higher K antigen, anti-phagocytic, live ability in the blood increasing E. coli capability in causing UTIs.14 Other uro-pathogen is adhering with uro-epithelium in different mechanism.6,10

 According to Hooton et al13,14 the relative risk to have UTI in every women are still exist eventhough no sexual activity and will increase in the 4th day to 3.5 times and even become to 14.1 times if the women in the past 7 days used diaphragm - spermicide.

 

Why Resistance to Fosfomycin tromethamole in Urinary E. coli Remains so Rare?17

According to Schito, Kobayashi and Stamm, because first of all, the usage of fosfomycin tromethamole is limited only to acute uncomplicated cystitis, it provides the patient with a daily Single Dose and does not include any other instructions, nor does it extend to veterinary medicine or to additional auxinic objectives in animal food.

Secondly, they recall that the mechanism responsible for the resistance to Fosfomycin tromethamole is uncommon and usually chromosomial (mutations of the genes which encode the transportation mechanisms with alpha-glycerophosphate). Also the acquisition of resistances by means of plasmids is extreme­ly rare, differing from the incidences of cotrimoxazole and bedta-lactams.

Then, the absence of strains fosmycin resista­nt in the faecal flora must be highlighted.17 Fosfomycin tromethamole is able to facilit­ate the breaking down of preformed biofilm, as demonstrated by the study which evaluated the surviaval E.coli after being expose­d to such antibiotic for 24 hours.

 The data were obtained from the urine specimen that are collected from general hospit­al Cipto Mangunkusumo (RSCM) Jakarta and examined in Clinical Microbiology Laboratory LMK), Microbiology Department FKUI from 2002 to 2004, showed that the most common microbial etiology of urinary tract infection was Escherichia coli. The data showed that E.coli is 100% sensitive to Fosfomycin in 2002, 95% in 2003 and back again to 100% sensitive to Fosfomycin in 2004.12

Resistance problem as the risk factor in the successful treatment of infection case. Resistance problem can be prevented by 4 strategies: 1207AKN2-Tabel 1

prophylaxis an infection, diagnose and treat effectively, use antibiotic wisely and avoid the contagion of infection.

 

Recurrent UTI

Recurrent UTI (RUTI) occurs due to relapse­s or re-infection and common among young, healthy women, even though they generally have anatomically and physio­logicall­y normal urinary tracts. Recurrent UTI is defined in the literature by 3 episodes of UTI in the last 12 months or 2 episodes in the last 6 months. Risk factors for RUTI are genetic and behavioural include sexual activity (IIa). Behavioural factors associated with RUTISome studies estimate that 20-30% of women who have a UTI will have a RUTI. RUT­I result in significant discomfort for women and have a high impact on ambulatory health care cost as a result of out patients visits, diag­nostics tests and prescriptions.

Predisposing factors in recurrrent UTI women can be grouped as follows:

1. Intrinsic. Higher prevalence for adherence of bacteria and vaginal colonization.  Intrinsic factors are frequently difficult to be managed by most of the people.

2. Extrinsic. It is easily managed and included such as sexual activity, use diaphragm or spermicide, delay post-coital mixturition, fecal-vaginal contamination, voiding after sexual intercourse, post-voiding residual urine, and new sexual partner.

Women who have previously experienced acute cystitis are highly reliable for self-diagnosis. 94% of self-diagnosis where confirmed by laboratory testing. Antimicrobial prophylaxis for prevention of recurrent UTI should be considered only after counseling and behaviou­ral modification has been attempted (LE:4; GR:A). Before any prophylaxis regimen is initiated, eradication of previous UTI should be confirmed by a negative urine culture 1-2 weeks after treatment (LE:4, GR:A). Conti­nuous and postcoital antimicrobial prophylaxis should be considered to prevent recurren­t uncomplicated cystitis in women in whom non-antimicrobial measures have been unsuccessful (LE:1A; GR:A).

 

UTIs in Pregnancy

Urinary tract infections are common durin­g pregnancy. Most women acquire bacteriur­ia before pregnancy, while 20-40% of women with asymptomatic bacteriuria will develop pyelonephriitis during pregnancy. In the pregnant women, bacteriuria will be more persistent due to dilatation of urethra, influence of hormonal changed, and the increa­sed of the capacity of urinary bladder.

Pregnant women should be screened for bacteriuria during the 1st trimester  (LE:1a,GR:A). Asymptomatic bacteriuria detected in pregnancy should be eradicated with antimicrobial therapy (LE:1a, GR:A).

Short courses of antimicrobial therapy (3 days) should be considered for the treatment of asymptomatic bacteriuria and cystitis in pregnancy (LE:1a,GR:A). Urine cultures should be obtained soon after completion of therapy for asymptomatic bacteriuria and symptomatic UTI in pregnancy (LE:4,GR:A).

Postcoital prophylaxis should be consi­dere­d in pregnant women with a history of frequent UTIs before onset of pregnancy, to reduce their risk of UTI (LE:2b,GR:B).

 

Diagnosis of UTI

The diagnosis of acute uncomplicated cystiti­s can be made with a high probability based  on a focused history of urinary irritative symptomatology (dysuria, pain, bladder tenderness, polakysuria, frequency, and urgen­cy) and the absence of vaginal discharge or irritation, in those women who have no other risk factors for complicated UTIs (LE:2a,GR:B). Approximately 40% of women with cystitis have haematuria.

 

 Laboratory diagnosis of UTI is based on 2 principals method :

1. Urine microscopic examination is the first step in the laboratory diagnosis of UTI. Each leucocyte seen in the cediment represe­nted 5-10 cell/ mm3 urine. 10-50 leucocyte/mm3 assumed as upper normal limit. 5-10 leucocytes per view in cediment from midstream clean urine is the upper normal limit. Urinalysis (e.g. using dipstick method) to look for pyuria, haematuria, and nitrites is indicated if a UTI is suspected or treatment of acute UTI with antibiotic failed. Pyuria is present in almost all women with an acutely symptomatic UTI and in most women with urethritis caused by N.gonorrhoeae or C.trachomatis.

2. Diagnosis of a UTI can be also done by urine culture. Urine in urinary bladder normally is sterile. The definitive diagnosis of a UTI is made in the presence of significant bacteriuria. The following bacteriurial counts are clinically relevant:

- > 103 cfu/mL (colony formed unit) of uropathogens in a mid-stream sample of urine (MSU) in acute uncomplicated cystiti­s in woman.

> 104 cfu/mL of uropathogens in an MSU in acute uncoamplicated pyelo­nephritis in a woman.

> 105 cfu/mL of uropathogens in an MSU in a woman, or = 104 cfu/mL uropathogens in an MSU in a man, or in straight catheter urine in women, in a complicated UTI.

Asymptomatic bacteriuria is diagnosed if two cultures of the same bacterial strain (in most cases the species only is available) taken > 24 hours apart show bacteriuria of = 105 cfu/mL of uropathogens.

 

Prevention of Catheter-Related UTIs

Urinary catheter should only be used when clearly needed and not just for convenience. Catheter should be removed when they are no longer needed. Infection occur less often with using intermittent catheterization compared to indwelling catheter.

Routine care of the indwelling catheter must include daily cleansing of the urethral area and the catheter with soap and water. Clean the area thoroughlyafter all bowel movements to prevent infection.Expert no longer recommend using antimicrobial ointments around the catheter,  as they have not been shown to actually reduce infections.

Increase fluid intake to 3,000 cc of fluid per day, unless you have a medical condition that prohibits this increase. Also always keep the drainage bag lower than the bladder to prevent a back of urine into the bladder.

Empty the drainage device at least every 8 hours or when it is full. Take care to keep the outlet valve from becoming infected. Wash your hand before and after handling the drainage device.

 Your health care provider may prescribe a daily low-dose antibiotic to control bacterial growyh in an indwelling catheter, Cranberry juice or vitamin C may also be recommended to help prevent UTIs.

 

Treatment of Catheter-related UTIs

 Goals of therapy are quick relieves of symptoms, complete eradication of a pathogen, prevention of recurrence and minimization of drug toxicity. In mild cases of acute UTI may disappear on their own without treatment. However, because of the risk of the infection spreading to the kidneys (Complicated UTI), treatment is usually recom­mended. In most cases, treatment can be done on an out patients basis.

 Antibiotic therapy is recommended becau­se clinical success is significantly more likely in women treated with antibiotics compared with placebo (LE:1a, GR:A). In the past, 7-10 days of therapy were routinely recommended for patients with lower urinary tract infection, However, in recent years it has become apparent that most women with lower UTI have only a superficial mucosal infection and can be cured with much shorter courses of therapy, and in fact with only a single dose of specific antimicrobial agents. Single-dose therapy with certain agents achieves high urinary concentrations that are prolonged for at least 12-72 hours and eliminates infection when presumably confined to the bladder.

 The clinical studies carried out with fosfomycin in the last two decades have played an important role in promoting this new approa­ch. The advantages of single-dose therapy are better compliance, fewer side-effec­ts and lower cost.

 IDSA-ESMID Guidelines 2011 and EAU Guidelines 2011 are not recommended at all empirically antimicrobial if the resistance rate in the community reached > 20%.1,2 

 

Fosfomycin Tromethamole20

 Fosfomycin is a unique phosphonic acid derivative, bactericidal and broad antibac­terial spectrum of activity against the most common Gram-positive and Gram-negative bacteria responsible for UTIs. It was first dis­co­v­ered in Spain in 1969. Its chemical structure, (-)-cis-1,2 –epoxypropyl phosphonic acid, combines an epoxide ring and a carbon-phosphorus bond. Since the early 1980s a salt of fosfomycin, known as fosfomycin tro­me­thamole, has been available which is highly water soluble and thus more reliable for oral administration because of its better bio­availbilit­y. An important role in a single-dose therap­y is that of Fosfomycin tromethamole, a new molecul was developed by Zambon S.p.A. Italy that has been extensively used worldwide since 1988.

 Fosfomycin tromethamole acts by inhibitin­g pyruvyl transferase, a cytoplasmic enzyme that catalyses the first step in the biosynthesis of peptidoglycans, which is needed for formation the membrane wall of bacteria cell.

 After a single oral dose of fosfomycin tromethamole (3 g of fosfomycin) in healthy volunteers, mean peak plasma concentrations (Cmax) ranged from 22 to 32 mg/l and were reached between 2 and 2.5 hours (tmax). The oral bioavailability of a single dose of fosfom­ycin trometamol ranges from 34% to 41%, but this proportion increases to 54-65% when expressed as a ratio of the total oral dosage recovered in the urine.

Fosfomycin is primarily excreted unchanged in the urine by glomerular filtration. The total body and renal clearance are quite similar; only 0.5% of fosfomycin is excreted by the biliary route. The mean peak of urinary concentration of fosfomycin, with values ranging from 1053 to 4415 mg/l, was recovere­d in the 4 hours following the administrat­ion of a single oral dose. Urinary concentration above the MIC values for E. coli persist at least for 80 hours and adequate to kill most urinary pathogens. MIC 90 E. coli is 2-4 ug/ml.

 Fosfomycin is absorbed from gastro-intestin­al tract. Absorption is improved three times by complex with tromethamole through esterification process increase the solubility of drug in the lipid than calsium salt. The increase of bioavailability is also through production of salt fosfomycin from different ionization level lead higher solubility in the water.

 Bergan et al (1993) reported that urinary therapeutical level of fosfomycin trometha­mole is still longer after oral administration compared with intra venous administration of sodium (natrium) fosfomycin, which the urinar­y concentration of sodium fosfomycin decreased very fast  and after 36 hours is not found anymore in the urine. This is the reason why sodium fosfomycin was not recommended by IDSA and EAU for treatment of uncomplicated UTI. Please see figure number 1 and 2.

Fosfomycin tromethamole is recom­men­de­d as “first-line therapy” for women with Acute Uncomplicated Cystitis, IDSA-ESMID Guidelines 2011 and EAU Update March 2011. Also as first- line therapy for recurrent UTI, asympyomatic bateriuria and acute cystitis in pregnant women is recommended by EAU Guidelines 2011.

 Advanced renal insufficiency significantly affects the pharmacokinetics of Fosfomycin. Pregnancy does not seem to modify serum and urinary fosfomycin concentration, and dose modifications are not required.

 Fosfomycin has a broad antimicrobial spectrum of activity against the most common Gram-positive and Gram-negative bacter­ia responsible for UTIs. More over, it is rapidly bactericidal at low concentration. Fosfomycin has proved to be active against E. coli, Enterobacter sp, Citrobacter sp, Klebsiela sp, Proteus sp, Staphylococcus sp. (including methicillin–resistant strains).

Fosfomycin tromethamole is able to reduce the adhesion of tested bacterial strains, both Gram-positive and Gram-negative, to uroepithelial cells, an effect observed at sub-inh­ib­itory concentrations. Fosfomycin tromethamole is able to facilitate the breaking down of preformed biofilm, as demons­trat­ed by the study which evaluated the surviv­al of E. coli after being exposed to such antibiotic for 24 hours. Fosfomycin trome­thamole also disrupts the matured biofilm, this activity will ensure the bacterial eradication and successful of treatment.

 

International Clinical Evidence-Based on Fosfomycin Tromethamole

The efficacy of Fosfomycin tromethamole has been evaluated by several prospective comparative studies, conducted both in United States and in Europe.The overall results, including more than 6000 patients in different clinical trial with different designs, but all comparing the efficacy of single dose of 3 g of Fosfomycin tromethamole with that of other either single or multipled-dose antimicrobials agents, showed a bacteriological cure rate ranging from75% to 100%, comparable with that obtained using the other agents.

The bacteriological efficacy of fosfomycin in non-blind comparative studies ranged from 84% to 100%, compared to 72%-93% obtain­ed with the comparators. In randomized double-blind multicentre comparative studies, bacteriological cure rates ranged from 75% to 90%.

The efficacy of Fosfomycin was also tested in the prophylaxis of UTI following diagnostic or surgical procedures. In this setting, Fosfomycin has been shown to be more effect­ive than either amoxycillin or co-trimoxazo­le.

 In a randomized study, a single-dose regime­n of fosfomycin tromethamole was as effective as a multiple-dose regimen of Pipemidic acid in the treatment of bacteriuria in pregnant women. A recent review from Pacifici concludes (Int. J. Clin Pharmacol Ther, 2006; 44:57-63), Fosfomycin tromethamole thanks to its pharmacokinetic profile, passes the placenta barrier and can be used during the course of pregnancy for the treatment of infections in the mother or the foetus. It was, as matter of fact, classified in category B by the FDA USA and it usage is therefore allowed when deemed necessary. Clinical evidenc­e has demonstrated both its efficacy and safety in this condition. 

 Miniello (1996) has reported that Fosfomycin tromethamole single-dose 3 g is give­n every 10 (ten) days for 3 months effective to prevent recurrent UTI. This effect is superi­or than nitrofurantoin 50 mg /day for 3 months.24

 Utama T.P.(2007) from Obstetry-Gynaecology Dept. RS Hasan Sadikin FK UNPA­D, Bandung, conducted the comparison study between Fosfomycin tromethamole singl­e-dose 3 g and Ciprofloxacin 500 mg b.i.d. for 5 days in 70 women with uncomplicated cystitis. He reported that both clinical and microbiological efficacy Fosfomycin tromethamole was better and significantly difference than ciprofloxacin 94,29% of patien­ts versus 88,57% for clinical efficacy and 85,7% versus 60% for microbiological efficac­y.29

Nurgul Eran et al (2010) have concluded the result of a randomized comparative study of single dose Fosfomycin and 5 a-day ciprofloxacin in female patients with uncomplicated lower UTIs that, a single dose of Fosfomycin tromethamole 3g was as effective as ciprofloxaicin at 500mg twice a day for 5 days. Fosfomycin tromethamole as a first-line treatment in the empirical treatment of uncomplicated UTIs might have a posistive impact on the problem of resistance to other antibiotics.39

Matthew E. Falagas et al (2010) have conduct­ed meta-analysis 27 of randomized controlled trials with total 1,917 patients. The conclusions: In the era of high drug resistance rates, reported even among community-acquir­ed uropathogens Fosfomycin trome­tha­mole may provide a valuable alternative option for the treatment of cystitis in non-preg­n­ant and pregnant women and in elderly and paediatric patietnts.38

 Simon Auer et al (2010) said that an increase in extended-spectrum-ß-lactamase (ESBL)-producing Escherichia coli has been observed in outpatients settings. 100 ESBL-positive E. coli isolates from ambulatory patients with clinically confirmed UTIs were collect­ed by a single laboratory between October 2004 and January 2008. Suscepti­bility rates indicates that Fosfomycin (97%), nitrofurantoin 94% and pivmecillinam (85%) could be considered important oral treatment options.37

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Safety

 Results of clinical trials have demonstrated that Fosfomycin tromethamole, administered  as a single oral dose, is generally safe and well tolerated. In total, the data reported from clical trials include 8707 patients. In the overall evaluation of the patients who received Fosfomycin tromethamole, the most frequently observed adverse events were diarrh­oea (4%), headache (2%), nausea (2%) and epigastric pain (1.3%).

No cases of foetotoxicity related to the use of Fosfomycin have been reported in 246  pregnant women treated with a single oral dose of Fosfomycin 3 g.

Fosfomycin tromethamole, thanks to its pharmacokinetic profile, passes the placenta barrier and can be used during the course of pregnancy for the treatment of infections in the mother or the foetus. It was clasiified in category B by the FDA since 19th December 1996, so it could be used in pregnancy after first trimester if necessary, whereas other agents, such as ciprofloxacin and co-trimoxazole, are rated in category C, meaning that risk to the foetus cannot be ruled out. Category B is the highest level for a drug in pregnancy and no category A in pregnancy.

Fosfomycin tromethamole also can be given for treatment UTI in children. Fosfo­my­cin was administered as 2 g single-dose or dose 18-80 mg/kg BW/day. Bergan (1988) has report­ed that no inter-action between Fosfomycin tromethamole and Cimetidine, but administration together with metoclopra­mide can reduce the absorption of Fosfo­my­cin tromethamole significantly. Admi­nistra­tion of metoclopramide is not give­n together with Fosfomycin tromethamole.

Dosage and Administration of Fosfomycin Tromethamole

Treatment of Acute Uncomplicated UTI: Fosfomycin Tromethamole 3 g (1 Sachet) singl­e dose. Recurrent UTI: Fosfomycin Tromethamole 3 g single dose every 10 days for 3 months. Asymptomatic bacteriuria in pregnant women after 1st trimester: Fosfomycin tromethamole 3 g single dose.

Prophylaxis of lower UTI in transurethral diagnostic manouvers and before inserting catheter: Two Fosfomycin tromethamole dose­s. The first dose FT 3 g is administered 3 hours before the intervention and the second dose FT 3 g 24 hours after the first one.

Fosfomycin tromethamole 3 g is dissolved in 50-75 ml water (orange taste), only adminis­tered orally in an empty stomach, preferably at bedtime, after emptying the bladder.

 

Conclusion

Invasive device such as catheter are the leading causes of infection in healthcare faciliti­es. CAUTI account for up to 40% of healthcare-associated infections (HAIs) in hospita­ls, lomg term care and home care. Short-term antibiotic therapy is the treatment of choice according to the recommendation of IDSA –ESMID Guidelines 2011 and EAU Guidelines 2011. Choice of the best anti­micro­bials depends on epidemiological data (susceptibility and resistance rate) and drug properties (pharmacokinetic and pharmacodynamic). Any improvement on treatment management will have an high impact on health care, excellent prognosis for renal function and health economics. Fosfomycin tromethamole (FT) is just a single dose as FIRST LINE Therapy of Acute Uncomplicated Cystitis, Asymptomatic bacteriuria and Cystitis in Pregnancy, and for Recurrent UTI with dose FT 3 g every 10 days recommended by international Guidelines such as EAU Guideline Update 2011 and IDSA-ESMID Guidelines 2011. International clinical evidences have demonstrated both its efficacy and safety of Fofomycin tromethamole. n 

 

References

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  2.  M. Grabe et al. European Association of Urology (EAU) 2011. Guidelines on Urological Infections. Update March 2011.
  3. K.G. Naber et al. European Association of Urology (EAU) 2006. Guidelines on The Management of Urinary and Male Genital Tract Infections.
  4. Warren J.W. et al. Infectious Disease Society of America (IDSA). Guidelines for Antimicrobial Treatment of Uncomplicated Acute Bacterial Cystitis and Acute Pyelonephritis in Women. Clin Inf Dis 1999: 29:745-758.
  5. Rosenberg M. Pharmacoeconomics of treating uncomplicated urinary tract infections. Int J Antimicrob Agents. 1999; 11: 247-251.
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