Single-dose versus 3-day cotrimoxazole prophylaxis in transurethral resection or greenlight laser vaporisation of the prostate: study protocol for a multicentre randomised placebo controlled non-inferiority trial (CITrUS trial).

BACKGROUND: Transurethral resection of the prostate (TURP) and Greenlight laser vaporisation (GL) of the prostate are frequently performed urological procedures. For TURP, a single-dose antimicrobial prophylaxis (AP) is recommended to reduce postoperative urinary tract infections. So far, no international recommendations for AP have been established for GL. In a survey-based study in Switzerland, Germany and Austria, urologists reported routinely extending AP primarily for 3 days after both interventions. We therefore aim to determine whether single-dose AP with cotrimoxazole is non-inferior to 3-day AP with cotrimoxazole in patients undergoing TURP or GL of the prostate. METHODS/DESIGN: We will conduct an investigator-initiated, multicentre, randomised controlled trial. We plan to assess the non-inferiority of single-dose AP compared to 3-day AP. The primary outcome is the occurrence of clinically diagnosed symptomatic urinary tract infections which are treated with antimicrobial agents within 30 days after randomisation. The vast majority of collected outcomes will be assessed from routinely collected data. The sample size was estimated to be able to show the non-inferiority of single-dose AP compared to 3-day AP with at least 80% power (1 - ß = 0.8) at a significance level of α = 5%, applying a 1:1 randomisation scheme. The non-inferiority margin was determined in order to preserve 70% of the effect of usual care on the primary outcome. For an assumed event rate of 9% in both treatment arms, this resulted in a non-inferiority margin of 4.4% (i.e. 13.4% to 9%). To prove non-inferiority, a total of 1574 patients should be recruited, in order to have 1416 evaluable patients. The study is supported by the Swiss National Science Foundation. DISCUSSION: For AP in TURP and GL, there is a large gap between usual clinical practice and evidence-based guidelines. If single-dose AP proves non-inferior to prolonged AP, our study findings may help to reduce the duration of AP in daily routine-potentially reducing the risk of emerging resistance and complications related to AP. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03633643 . Registered 16 August 2018.

A Seven-Day Course of TMP-SMX May Be as Effective as a Seven-Day Course of Ciprofloxacin for the Treatment of Pyelonephritis.

BACKGROUND: The Infectious Diseases Society of America guidelines recommend either 14 days of trimethoprim-sulfamethoxazole (TMP-SMX) or 7 days of ciprofloxacin for the treatment of pyelonephritis. Antibiotic courses of 7 days of TMP-SMX vs 7 days of ciprofloxacin for pyelonephritis have not been previously compared. We evaluated the odds of a subsequent, symptomatic urinary tract infection (UTI) for women with Escherichia coli pyelonephritis receiving a 7-day course of TMP-SMX vs a 7-day course of ciprofloxacin. METHODS: Women ages 16 years and older with E. coli pyelonephritis presenting to 5 health care facilities in the greater Maryland area between 2010 and 2016 receiving either TMP-SMX or ciprofloxacin were included. Patients were excluded if they met any of the following criteria: (a) pregnancy, (b) dialysis dependency, (c) E. coli not susceptible to the treatment prescribed, (d) polymicrobial urine culture, or (e) >48 hours of antibiotic therapy other than TMP-SMX or ciprofloxacin. RESULTS: Of 272 women meeting eligibility criteria, 81 (30%) and 191 (70%) received 7 days of TMP-SMX and 7 days of ciprofloxacin, respectively. In an adjusted model, the likelihood of a recurrent UTI within 30 days for the TMP-SMX and ciprofloxacin groups was similar (adjusted odds ratio 2.30; 95% confidence interval, 0.72-7.42). CONCLUSIONS: Our findings suggest that 7 days of TMP-SMX therapy may result in similar clinical outcomes compared with 7 days of ciprofloxacin for the treatment of pyelonephritis. Considering the frequency of pyelonephritis and risks of antibiotic resistance and associated toxicities, decreasing the duration of antibiotic therapy for pyelonephritis may impact a large number of women.

Outcomes of high-dose levofloxacin therapy remain bound to the levofloxacin minimum inhibitory concentration in complicated urinary tract infections.

BACKGROUND: Fluoroquinolones are a guideline-recommended therapy for complicated urinary tract infections, including pyelonephritis. Elevated drug concentrations of fluoroquinolones in the urine and therapy with high-dose levofloxacin are believed to overcome resistance and effectively treat infections caused by resistant bacteria. The ASPECT-cUTI phase 3 clinical trial (ClinicalTrials.gov, NCT01345929 and NCT01345955 , both registered April 28, 2011) provided an opportunity to test this hypothesis by examining the clinical and microbiological outcomes of high-dose levofloxacin treatment by levofloxacin minimum inhibitory concentration. METHODS: Patients were randomly assigned 1:1 to ceftolozane/tazobactam (1.5 g intravenous every 8 h) or levofloxacin (750 mg intravenous once daily) for 7 days of therapy. The ASPECT-cUTI study provided data on 370 patients with at least one isolate of Enterobacteriaceae at baseline who were treated with levofloxacin. Outcomes were assessed at the test-of-cure (5-9 days after treatment) and late follow-up (21-42 days after treatment) visits in the microbiologically evaluable population (N = 327). RESULTS: Test-of-cure clinical cure rates above 90% were observed at minimum inhibitory concentrations ≤4 µg/mL. Microbiological eradication rates were consistently >90% at levofloxacin minimum inhibitory concentrations ≤0.06 µg/mL. Lack of eradication of causative pathogens at the test-of-cure visit increased the likelihood of relapse by the late follow-up visit. CONCLUSIONS: Results from this study do not support levofloxacin therapy for complicated urinary tract infections caused by organisms with levofloxacin minimum inhibitory concentrations ≥4 µg/mL. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01345929 and NCT01345955.

NMR-based metabolomics reveals urinary metabolome modifications in female Sprague-Dawley rats by cranberry procyanidins.

A (1)H NMR global metabolomics approach was used to investigate the urinary metabolome changes in female rats gavaged with partially purified cranberry procyanidins (PPCP) or partially purified apple procyanidins (PPAP). After collecting 24-h baseline urine, 24 female Sprague-Dawley rats were randomly separated into two groups and gavaged with PPCP or PPAP twice using a dose of 250 mg extracts per kilogram body weight. The 24-h urine samples were collected after the gavage. Urine samples were analyzed using (1)H NMR. Multivariate analyses showed that the urinary metabolome in rats was modified after administering PPCP or PPAP compared to baseline urine metabolic profiles. 2D (1)H-(13)C HSQC NMR was conducted to assist identification of discriminant metabolites. An increase of hippurate, lactate and succinate and a decrease of citrate and α-ketoglutarate were observed in rat urine after administering PPCP. Urinary levels of d-glucose, d-maltose, 3-(3'-hydroxyphenyl)-3-hydroxypropanoic acid, p-hydroxyphenylacetic acid, formate and phenol increased but citrate, α-ketoglutarate and creatinine decreased in rats after administering PPAP. Furthermore, the NMR analysis showed that the metabolome in the urine of rats administered with PPCP differed from those gavaged with PPAP. Compared to PPAP, PPCP caused an increase of urinary excretion of hippurate but a decrease of 3-(3'-hydroxyphenyl)-3-hydroxypropanoic acid, p-hydroxyphenylacetic acid and phenol. These metabolome changes caused by cranberry procyanidins may help to explain its reported health benefits and identify biomarkers of cranberry procyanidin intake.

[REHABILITATION OF PATIENTS WITH URIC ACID AND MIXED UROLITHIASIS].

This paper presents evaluation of rehabilitation effectiveness of 113 patients aged 19-78 years diagnosed as having mixed and uric acid stones. 88 patients with uric acid stones 0,5-2,5 cm were assigned to group 1 and treated with Trometamol N parenteral litholis and a complex metaprophilaxis by dietary supplements Prolit and Urisan. 25 patients with mixed stones 1-3,5 cm were allocated to group 2 and treated with external shock wave lithotripsy and complex metaprophilaxis by dietary supplements Prolit Super Septo and Urisan. Positive results were achieved in all the patients. In the patients of group 1 the stones were completely dissolved. In group 2 treatment resulted in stone disintegration and clearance of small fragments 0,4 cm after partial dissolution.

Ciprofloxacin resistance in the faecal carriage of patients undergoing transrectal ultrasound guided prostate biopsy.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Transrectal ultrasound guided prostate biopsies (TRUSBx) are associated with a spectrum of complications, including most significantly infection, which affects up to 5% of patients. In the most severe cases, infection leads to sepsis, a life-threatening complication. Escherichia coli is the primary responsible pathogen. Although antibiotic prophylaxis with fluoroquinolones is routinely used, there is evidence that the infection rate after TRUSBx is increasing, and this appears to be due to an increasing prevalence of ciprofloxacin-resistant rectal flora. This is the largest prospective clinical trial to date analysing the rectal flora of men undergoing prostate biopsies. We determined the microbial and antibiotic sensitivity profiles from 849 patients. Ciprofloxacin-resistant Gram-negative organisms were identified in the rectal flora of 19.0% of men. Furthermore, fluoroquinolone use within 6 months preceding a TRUSBx and the presence of a prosthetic heart valve were significant predictors of ciprofloxacin resistance on rectal swab. Determining the prevalence of rectal fluoroquinolone resistance has important implications in evaluation of the suitability of prophylactic regimens. Antimicrobial profiles derived from rectal swabs pre-biopsy may prove useful in guiding targeted antibiotic prophylaxis. OBJECTIVES: To establish the prevalence of ciprofloxacin-resistant bacteria in patients undergoing transrectal ultrasound guided prostate biopsies (TRUSBx) and to determine whether this predicts subsequent infectious complications. To identify risk factors for harbouring ciprofloxacin-resistant flora. PATIENTS AND METHODS: Any patient undergoing a TRUSBx from 2009 to 2011 was eligible for enrolment in this prospective study. Pre-biopsy rectal and urine cultures and post-biopsy urine cultures were obtained and antimicrobial susceptibility was determined. Univariate and multivariate analyses were performed to identify independent patient risk factors associated with ciprofloxacin-resistant rectal flora. RESULTS: A total of 865 patients underwent TRUSBx, of whom 19.0% were found to have ciprofloxacin-resistant Gram-negative coliforms. Escherichia coli was the most prevalent Gram-negative rectal isolate (80.9%) and accounted for 90.6% of ciprofloxacin resistance. Patient characteristics that conferred an increased risk of harbouring ciprofloxacin-resistant organisms included a history of a heart valve replacement (P < 0.05) and ciprofloxacin use in the past 3 months (P < 0.05). Infectious complications were observed in 3.6% (n = 31) of the patient population and 48% of these patients grew ciprofloxacin-resistant organisms on the pre-biopsy rectal swab (P < 0.001). CONCLUSIONS: Antimicrobial resistance to ciprofloxacin in the rectal flora was common, particularly in patients with recent ciprofloxacin use and a heart valve replacement. Despite a significant correlation between those patients who developed infections and the detection of ciprofloxacin-resistant organisms, only 9.0% (n = 15) of the total group with ciprofloxacin resistance developed an infectious complication. Future studies will need to evaluate the cost effectiveness and clinical utility of a pre-biopsy rectal culture in targeting antibiotic prophylaxis.

[Treatment and metaphylaxis of gout complicated by nephropathy and urolithiasis].

The evaluation of clinical efficacy of combined treatment and metaphylaxis in 58 patients with gout complicated by nephropathy and urolithiasis was performed. The study included 41 (71%) men and 27 (29%) women aged 44 to 88 years (mean age - 58 +/- 7 years). All patients received parenteral therapy with trometamol H, 5 -10 infusion for the course, an average of 7 infusions. For the metaphylaxis, all patients received biologically active supplement urisan 2 tablets 2 times a day during next three months against the background of drug therapy. Findings indicate a high clinical efficacy of the trometamol H in the combined treatment of patients with gout, complicated by nephropathy and urolithiasis, considering that improvement of renal function, microcirculation in the renal parenchyma, increased glomerular filtration rate, normalization of nitrogenous wastes levels, partial or complete dissolution of concretions of the kidneys, a significant decrease in the tophs size, an increase in motor activity were observed, which ultimately improves the quality of life for these patients. Metaphylaxis using urisan for 3 months on a background of traditional therapy contributed to a stable normalization of blood uric acid levels, which prevented the exacerbation of underlying disease and recurrent stone formation. These data allow to recommend reducing the dose of traditional anti-gout drugs and conducting repeated course of metaphylaxis with the urisan after 5-6 months during 3 months.

[Administration of vitaprost plus for prevention of infectious-inflammatory complications of transurethral prostatic resection in patients with prostatic adenoma].

The study of efficacy and safety of the drug vitaprost plus (rectal suppositories) in its use for prevention of infectious-inflammatory complications after transurethral resection (TUR) of the prostate for adenoma included 55 male surgical patients with prostatic adenoma (PA). The patients were randomized into two groups matched by age, symptoms and clinical data. The control group consisted of 20 patients (group 1), the study group--of 35 patients (group 2). TUR of the prostate was made in both groups, but patients of group 2 were given additional prophylactic treatment--vitaprost plus, one suppository before going to bed 2 days before surgery and for 8 days after TUR, the course lasted for 10 days. Postoperative blood and urine samples showed inflammatory changes more often in group 1, free of infection bacterial tests were more often in group 2. Renal microcirculation in group 1 after TUR evidenced for functional depression on perfusion intensity and renal ischemia and congestion. These changes persisted on postoperative day 8, being a potential cause of renal inflammation and ascending pyelonephritis. Group 2 patients exhibited insignificant postoperative microcirculatory disorders in the kidneys and were not registered on postoperative day 8. Infectious-inflammatory complications in group 1 patients were registered much more frequently than in group 2 patients. Thus, vitaprost plus can be recommended for prophylaxis of infectious-inflammatory complications of TUR in PA patients.

[Optimization of enuresis therapy in children using transcranial magnetotherapy].

A total of 58 children (age from 6 to 14 years) suffering from nocturnal enuresis (NE) were divided into two groups. The study group received basic therapy (driptan dose was reduced to 2.5 mg twice a day) in combination with transcranial bitemporal magnetotherapy (TcMT). The control group received placebo TcMT and basic therapy. It is shown that addition of TcMT to reduced basic therapy lowered the score of imperative voiding symptoms 1.3-fold, number of enuresis patients 1.7-fold, volume of the bladder 6.8 months after the treatment 1.9-fold, corrected vegetative status and activity of the subcortical nervous center in 24% children according to cardiointervalography versus the controls. Thus, TcMT improves clinical effect in NE patients in 2-fold reduction of pharmacological burden.

A double-blind, randomized comparison of levofloxacin 750 mg once-daily for five days with ciprofloxacin 400/500 mg twice-daily for 10 days for the treatment of complicated urinary tract infections and acute pyelonephritis.

OBJECTIVES: A clinical study was conducted to compare the efficacy and safety of levofloxacin 750 mg once daily for 5 days to ciprofloxacin twice daily for 10 days for the treatment of complicated urinary tract infections (cUTI) or acute pyelonephritis (AP). METHODS: A multicenter, double-blind, randomized, noninferiority study enrolled subjects with AP or cUTI. Subjects received either levofloxacin 750 mg intravenously or orally once daily for 5 days or ciprofloxacin 400 mg intravenously and/or ciprofloxacin 500 mg orally twice daily for 10 days and were evaluated at end of therapy, posttherapy, and poststudy for microbiologic eradication and clinical outcome. RESULTS: A total of 1109 subjects were enrolled; 619 with confirmed diagnosis of AP or cUTI and a study entry uropathogen with a colony count 10(5) CFU/mL or greater and were included in the modified intent-to-treat population. Five hundred six subjects met all criteria for inclusion and were included in the microbiologically evaluable population. At end of therapy, eradication rates in the modified intent-to-treat population were 79.8% for levofloxacin and 77.5% for ciprofloxacin-treated subjects (95% CI, -8.8% to 4.1%). In the microbiologically evaluable population, eradication rates were 88.3% for levofloxacin and 86.7% for ciprofloxacin-treated subjects (95% CI, -7.4% to 4.2%). Outcomes were comparable for the 2 treatments at posttherapy and poststudy. CONCLUSIONS: This study demonstrates that both drug regimens are safe and effective and that a 5-day course of therapy with levofloxacin, administered at a dose of 750 mg once daily, is noninferior to a 10-day course of therapy with ciprofloxacin for the treatment of AP and cUTI.

Short-course nitrofurantoin for the treatment of acute uncomplicated cystitis in women.

BACKGROUND: There is a paucity of data on the efficacy of nitrofurantoin for the treatment of acute uncomplicated cystitis in regimens shorter than 7 days. Evidence-based use of this drug is increasingly important as trimethoprim-sulfamethoxazole resistance among uropathogens increases. METHODS: To assess the efficacy of nitrofurantoin vs trimethoprim-sulfamethoxazole, 338 women aged 18 to 45 years with acute uncomplicated cystitis were randomized to open-label treatment with either trimethoprim-sulfamethoxazole, 1 double-strength tablet twice daily for 3 days, or nitrofurantoin, 100 mg twice daily for 5 days. Clinical cure 30 days after therapy was the main outcome measure. Secondary outcomes included clinical and microbiological cure rates 5 to 9 days after therapy and, for trimethoprim-sulfamethoxazole-treated women, clinical cure stratified by the trimethoprim-sulfamethoxazole susceptibility of the uropathogen. RESULTS: Clinical cure was achieved in 79% of the trimethoprim-sulfamethoxazole group and in 84% of the nitrofurantoin group, for a difference of -5% (95% confidence interval, -13% to 4%). Clinical and microbiological cure rates at the first follow-up visit were also equivalent between the 2 groups. In the trimethoprim-sulfamethoxazole arm, 7 of 17 women (41%) with a trimethoprim-sulfamethoxazole-nonsusceptible isolate had a clinical cure compared with 84% of women with a trimethoprim-sulfamethoxazole-susceptible isolate (P < .001). CONCLUSION: A 5-day course of nitrofurantoin is equivalent clinically and microbiologically to a 3-day course of trimethoprim-sulfamethoxazole and should be considered an effective fluoroquinolone-sparing alternative for the treatment of acute cystitis in women.

Assessing adherence to evidence-based guidelines for the diagnosis and management of uncomplicated urinary tract infection.

OBJECTIVE: To assess adherence to evidence-based guidelines for the diagnosis and management of uncomplicated urinary tract infection (UTI) in a family medicine residency clinic setting. PATIENTS AND METHODS: We retrospectively reviewed the medical records of female patients seen in 2005 at the Mayo Clinic Family Medicine Center in Scottsdale, Ariz, who were identified by International Classification of Diseases, Ninth Revision code 599.0 (UTI). We assessed documentation rates, use of diagnostic studies, and antibiotic treatments. Antibiotic sensitivity patterns from outpatient urine culture and sensitivity analyses were determined. RESULTS: Of 228 patients, 68 (30%) had uncomplicated UTI. Our physicians recorded essential history and examination findings for most patients. Documentation of the risk of sexually transmitted disease differed between residents and attending physicians and was affected by patient age. Urine dipstick and urine culture and sensitivity analyses were ordered in 57 (84%) and 52 (76%) patients, respectively. Eighty percent of patients with positive results on urine dipstick analyses also had urine culture and sensitivity analyses. Sulfamethoxazole-trimethoprim (SMX-TMP) was used as initial therapy in 26 patients (38%). Sixty-one percent of SMX-TMP and ciprofloxacin prescriptions were appropriately provided for 3 days. Escherichia coil was sensitive to SMX-TMP in 33 (94%) of 35 cultures. Treatment was not changed in any patient with an uncomplicated UTI because of results of urine culture and sensitivity analyses. Antibiotic sensitivity patterns for outpatients were significantly different from those for inpatients. CONCLUSION: Only 30% of our patients had uncomplicated UTI, making their management within clinical guidelines appropriate. However, of those patients with uncomplicated UTI, less than 25% received empirical treatment as suggested. Urine culture and sensitivity analyses were performed frequently, even in patients who already had positive results on a urine dip-stick analysis. Although SMX-TMP is effective, it is underused. On the basis of these findings, we hope to provide interventions to increase SMX-TMP prescription, decrease use of urine culture and sensitivity analyses, and increase the frequency of 3-day antibiotic treatments at our institution.

Effect of allopurinol in chronic nonbacterial prostatitis: a double blind randomized clinical trial.

INTRODUCTION: The exact mechanism of chronic nonbacterial prostatitis has not been yet elucidated and the outcome with the current management is dismal. In this trial, we studied the effect of allopurinol in the treatment of this disease. MATERIALS AND METHODS: In this randomized double blind controlled trial, a calculated sample size of 56 were grouped into "intervention group" who received allopurinol (100 mg tds for 3 months) with ofloxacin (200 mg tds) for 3 weeks (n = 29) and "control group" who received placebo tablets with ofloxacin (n = 27). Patients' scores based on the National Institute of Health Chronic Prostatitis Symptom Score were recorded before therapy and then every month during the study. A four-glass study was performed before intervention and after 3 months. RESULTS: The 2 groups were similar regarding outcome variables. In the first month of study, a significant but similar improvement in symptom scores was observed in both groups. Microscopic examination of prostate massage and post-massage samples were also similar in both groups. No side effects due to allopurinol were observed in patients. CONCLUSION: We did not find any advantage for allopurinol in the management of chronic prostatitis versus placebo in patients receiving routine antibacterial treatment.

The treatment of urinary tract infections and use of ciprofloxacin extended release.

Urinary tract infections (UTIs) are one of the most common reasons people seek medical attention. There are > 50% of women who will have at least one UTI during their lifetime and most of these will require a physician visit and antibiotic treatment. The high prevalence continues to the in-patient setting where genitourinary infections are the most common nosocomial infection. The efficient diagnosis and effective treatment of UTIs is a major healthcare concern. Factors such as economic efficiency and emerging resistance are increasingly becoming more important considerations in providing patient care. In out-patient uncomplicated UTIs, Escherichia coli has been implicated in < or = 75-90% of cases. Although the prevalence in the in-patient setting decreases, E. coli is still the most common bacteria identified and present in 21-54% of urinary isolates. Trimethoprim-sulfamethoxazole has been the preferred first-line agent for uncomplicated out-patient UTIs where local resistance is < 10 - 20%. In recent years, resistance has superseded this threshold in most regions of the US and Europe. In these areas with increased resistance, fluoroquinolones have become a common first-line agent. Ciprofloxacin has been one of the most widely used fluoroquinolones and has a well-known safety profile, as well as excellent activity against most of the common uropathogens. Ciprofloxacin extended release (ER) is a recently released once-daily formulation that has been increasingly used with good clinical success. The pharmacokinetic and pharmacodynamic parameters of ciprofloxacin ER are shown to be at least equal to twice-daily ciprofloxacin and may even confer superiority as ciprofloxacin ER achieves a higher maximum serum concentration. This is supported by clinical studies, which have shown at least as effective clinical cure and bacteriological eradication rates. These studies have also demonstrated similar tolerability and side-effect profiles. Ciprofloxacin ER combines traditional ciprofloxacin's proven track record of efficacy and safety with favourable pharmacokinetics and convenient once-daily dosing. Increased patient compliance is associated with decreased treatment failures and can help slow the development of antimicrobial resistance. Economic considerations are also increasingly important and providing convenient and effective treatment leading to high clinical success decreases overall costs.

Effect of allopurinol in chronic nonbacterial prostatitis: a double blind randomized clinical trial

INTRODUCTION: The exact mechanism of chronic nonbacterial prostatitis has not been yet elucidated and the outcome with the current management is dismal. In this trial, we studied the effect of allopurinol in the treatment of this disease. MATERIALS AND METHODS: In this randomized double blind controlled trial, a calculated sample size of 56 were grouped into "intervention group" who received allopurinol (100 mg tds for 3 months) with ofloxacin (200 mg tds) for 3 weeks (n = 29) and "control group" who received placebo tablets with ofloxacin (n = 27). PatientsÆ scores based on the National Institute of Health Chronic Prostatitis Symptom Score were recorded before therapy and then every month during the study. A four-glass study was performed before intervention and after 3 months. RESULTS: The 2 groups were similar regarding outcome variables. In the first month of study, a significant but similar improvement in symptom scores was observed in both groups. Microscopic examination of prostate massage and post-massage samples were also similar in both groups. No side effects due to allopurinol were observed in patients. CONCLUSION: We did not find any advantage for allopurinol in the management of chronic prostatitis versus placebo in patients receiving routine antibacterial treatment.

Efficacy and safety of a novel once-daily extended-release ciprofloxacin tablet formulation for treatment of uncomplicated urinary tract infection in women.

The efficacy and safety of a novel once-daily extended-release ciprofloxacin (ciprofloxacin ER) 500-mg dose were compared with those of an immediate-release ciprofloxacin (ciprofloxacin IR) 250-mg twice-daily dose, each administered orally for 3 days in the treatment of acute uncomplicated urinary tract infection (uUTI) in women. Adult female outpatients (mean age, 39 years) with clinical signs and symptoms of acute uUTI and a positive pretreatment urine culture (> or =10(5) CFU/ml) were enrolled in a multicenter, randomized, double-blind, noninferiority trial. Patients were assessed at a test-of-cure visit (4 to 11 days posttreatment) and a late-posttreatment visit (4 to 6 weeks posttreatment) for microbiological and clinical outcomes and safety. The primary efficacy endpoint and microbiological eradication rate at the test-of-cure visit in the ciprofloxacin ER group (254/272; 93.4%) were noninferior to those in the ciprofloxacin IR group (225/251; 89.6%) (95% confidence interval [CI] of difference, -0.99%, 8.59%). Clinical-cure rates at the test-of-cure visit were 85.7% (233/272) for ciprofloxacin ER and 86.1% (216/251) for ciprofloxacin IR (95% CI of difference, -6.37%, 5.57%). At the late-posttreatment visit, microbiological and clinical outcomes were similar for the two treatments and consistent with test-of-cure results. Both treatments were well tolerated, but the frequencies of nausea and diarrhea were lower in the ciprofloxacin ER group than in the ciprofloxacin IR group (nausea, ER, 0.6%; IR, 2.2%; P = 0.033; diarrhea, ER, 0.2%; IR, 1.4%; P = 0.037). Once-daily ciprofloxacin ER was safe, effective, and noninferior to twice-daily ciprofloxacin IR in the treatment of acute uUTI. Additionally, ciprofloxacin ER was associated with significantly reduced frequencies of nausea and diarrhea.

Fosfomycin tromethamine in uncomplicated urinary tract infections: a clinical study.

The aim of our study was to verify if the empiric therapy with a single dose of 3 g fosfomycin tromethamine in patients with uncomplicated urinary tract infections (UTIs) was able to clinically resolveand to microbiologically eradicate the infection. A total of 387 out of the 400 patients (274 cases with acute and 113 cases with recurrent uncomplicated UTIs) were enrolled in the clinical study. Clinical and microbiological assessments were performed before and at 8-10 days after the administration. At follow-up high clinical recovery (88.9%) and bacteriological (94.9%) eradication rates were achieved. Gastrointestinal side effects were found in only 4.3% of patients. In conclusion, a single-dose administration regimen of fosfomycin tromethamine should be encouraged as a first choice of drug therapy for uncomplicated UTIs.

Piperitone from Mentha longifolia var. chorodictya Rech F. reduces the nitrofurantoin resistance of strains of enterobacteriaceae.

The diluted essential oil of Mentha longifolia (L.) var. chlorodictya Rech F. foliage enhanced the bactericidal activity of nitrofurantoin decreasing the minimum inhibitory concentration (MIC) of nitrofurantoin for nitrofurantoin-resistant strains of Enterobacteriaceae. Thin-layer chromatography (TLC) analysis of the essential oil detected a fraction (R(f) = 0.35, UV lambda(max) of 232.5), which was the most effective in enhancement of nitrofurantoin activity. Using gas liquid chromatography and known standards, the active fraction was identified as piperitone. 1 microl of the piperitone fraction decreased the MIC of nitrofurantoin 3-20 fold for the different strains of Enterobacteriaceae tested.

Antimicrobials for the treatment of urinary tract infection in pregnancy: practices in southern India.

PURPOSE: Although urinary tract infection (UTI) in pregnancy is a common medical problem, very little is known about the susceptibility patterns of bacteria causing UTI and the prescription practices for UTI in pregnancy in low-income countries. Studies were, therefore, carried out in southern India to document the susceptibility patterns and to compare these with prescription practices. METHODS: Data on susceptibility patterns of bacteria isolated in significant counts from urine of pregnant women suspected to have urinary infection were collected. Prescribing patterns for these infections were ascertained using a questionnaire. RESULTS: About 90% of E. coli causing UTI is still susceptible to nitrofurantoin, a relatively inexpensive and safe drug. However, less than 25% of doctors used it for treatment of cystitis. Cephalosporins were most commonly used in hospital practice for the treatment of UTI. Amoxycillin was being used widely to treat UTI in pregnancy in spite of high prevalence of resistance. There were wide variations in the duration of therapy and use of prophylaxis. CONCLUSIONS: Our findings indicate an urgent need for proper guidelines, dissemination of information to practitioners and supervision of antimicrobial usage in low income countries like India. Irrational and unnecessary drug use can be expensive and harmful.