Comparative trial of norfloxacin and trimethoprim-sulfamethoxazole in the treatment of women with localized, acute, symptomatic urinary tract infections and antimicrobial effect on periurethral and fecal microflora

Haase, D.; Harding, G. K. M.; Thomson, Marian; Kennedy, James; Urias, B.; Ronald, Allan R.

doi:10.1128/aac.26.4.481

Cited by 59 publications

(29 citation statements)

References 26 publications

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“…This is consistent with observations from short-term treatment with this antimicrobial agent (5,11) and with one earlier study in which the antimicrobial agent remained effective in eradicating colonization for 3 months (2). This study extends these earlier investigations by documenting that norfloxacin remains effective in suppressing aerobic gram-negative fecal flora for as long as 1 year of continuous therapy.…”

supporting

confidence: 81%

Prospective, randomized, placebo-controlled trial of norfloxacin for the prophylaxis of recurrent urinary tract infection in women

Nicolle

Harding

Thompson

et al. 1989

Antimicrob Agents Chemother

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Thirty women were randomized in a double-blind, placebo-controlled study to receive either norfloxacin, 200 mg orally daily at bedtime, or placebo for the prevention of recurrent bladder infection. Subjects were followed monthly to monitor compliance and symptoms, for urine culture and periurethral and anal canal swabs to monitor colonization, and for blood specimens for hematologic and biochemical studies to monitor safety. During 1 year of follow-up, 10 of 15 placebo subjects and none of 15 norfloxacin subjects developed infection (P < 0.001). Adverse effects occurred with equal frequencies in the two groups. For norfloxacin subjects, only 2 (1.6%) of 129 periurethral and 4 (3.1%) of 129 anal canal swabs showed colonization with aerobic gram-negative organisms, while 16 (22%) of 73 periurethral and 47 (64%) of 73 anal canal swabs from placebo subjects showed colonization. Daily therapy with norfloxacin at bedtime is effective in preventing recurrent cystitis. During 1 year of norfloxacin therapy, colonization was infrequent and superinfection with norfloxacinresistant organisms did not occur.From 2 to 10% of all women experience recurrent symptomatic bladder infections due to reinfection from the fecal reservoir (13). Extended prophylaxis with a low dose of some antimicrobial agents is effective for the prevention of such infections (9, 10). The efficacy of prophylactic therapy is due to at least two mechanisms: the eradication of gut colonization with aerobic gram-negative organisms which are potential uropathogens, as occurs with trimethoprimsulfamethoxazole; and intermittent sterilization of the urine, as is observed with nitrofurantoin (14).The recently introduced quinolone antimicrobial agents have a wide spectrum of activity, including most uropathogens, and achieve high levels in urine for extended time periods. These agents have been extensively investigated for the treatment of urinary tract infections (8). With short courses of therapy, eradication of members of the family Enterobacteriaceae from the gut flora has been documented (11), an observation which has been exploited in the use of these agents for the prophylaxis of infection in granulocytopenic patients (3). Thus, these agents should constitute effective prophylaxis for the prevention of recurrent lower urinary tract infection in women. This study was undertaken to assess the effectiveness of norfloxacin for this clinical indication. antimicrobial agents. Informed written consent was obtained from all patients enrolled in the study. MATERIALSStudy design. The study was a double-blind, randomized, placebo-controlled trial comparing the efficacy of norfloxacin, 200 mg daily at bedtime, with that of placebo. Study subjects were treated for 12 months or until urinary tract infection recurred. When either symptomatic or asymptomatic urinary tract infection developed, subjects were withdrawn from the study without breaking the randomization code. Patients were monitored at monthly intervals for 12 months or until withdrawal and were questioned abo...

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supporting

confidence: 81%

Prospective, randomized, placebo-controlled trial of norfloxacin for the prophylaxis of recurrent urinary tract infection in women

Nicolle

Harding

Thompson

et al. 1989

Antimicrob Agents Chemother

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“…Mild side effects from TMP-SMX included skin rash, fever, fatigue, mild headache, vaginitis, and epigastric pain. [8][9][10]14 Serious side effects from TMP-SMX included severe headache, severe anaphylaxis reactions, and severe gastrointestinal effects. 8,10 Mild side effects from norfloxacin included fatigue, dizziness, headache, nausea, and epigastric pain.…”

Section: Study Setting and Populationmentioning

confidence: 99%

“…[8][9][10]14 Serious side effects from TMP-SMX included severe headache, severe anaphylaxis reactions, and severe gastrointestinal effects. 8,10 Mild side effects from norfloxacin included fatigue, dizziness, headache, nausea, and epigastric pain. [8][9][10] Serious side effects from norfloxacin included severe gastrointestinal effects and central nervous system effects.…”

Section: Study Setting and Populationmentioning

confidence: 99%

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A Cost–Effectiveness Analysis of Treatment Strategies for Acute Uncomplicated Pyelonephritis in Women

Yen

Davis

Chen

et al. 2003

Academic Emergency Medicine

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At least 250,000 episodes of acute uncomplicated pyelonephritis are treated annually in the emergency department (ED). Trimethoprim-sulfamethoxazole (TMP-SMX) and norfloxacin have both been used as treatments for acute uncomplicated pyelonephritis. Objectives: To investigate the cost-effectiveness of two outpatient treatment strategies, TMP-SMX and norfloxacin, for acute uncomplicated pyelonephritis in adult women between the ages of 18 and 65 years. Methods: Common principles of cost-effectiveness analysis were used for this evaluation. The authors developed a decision tree to estimate the costs and effectiveness of two different treatment strategies: TMP-SMX 160/ 800 mg twice per day for 10 days and norfloxacin 400 mg twice per day for 10 days. The time frame of the decision tree was 11 days. Outcomes were expressed in U.S. dollars, quality-adjusted life-days (QALDs), and dollars per QALD. Sensitivity analyses were performed on most variables. Results: Norfloxacin is more effective and less costly than the alternative, TMP-SMX. Norfloxacin treatment will save $195.85 per patient, resulting in an aggregate saving of more than $40 million annually. Patients are expected to enjoy a better quality of life with an incremental 0.0601 QALD per patient, if they are treated with norfloxacin. These results are robust across a wide range of probabilities and costs. Conclusions: In this analysis, norfloxacin 400 mg twice a day was a more cost-effective treatment than TMP/SMX 160/800 mg twice a day for women with pyelonephritis. Key words: costs; cost-benefit analysis; pyelonephritis; norfloxacin; trimethoprim-sulfamethoxazole. ACADEMIC EMERGENCY MEDICINE 2003; 10:309-314. Acute uncomplicated pyelonephritis is a common disease seen in the emergency department (ED). At least 250,000 episodes of acute pyelonephritis occur annually in the United States.1 The typical features are flank pain, fever and chills with dysuria, urgency, and frequency. Antibiotic treatment is necessary to control infection and prevent suppurative complications.Outpatient treatment is an effective and safe management for patients with acute uncomplicated pyelonephritis.2-7 Prior studies have focused on comparing efficacies of fluoroquinolones and trimethoprim-sulfamethoxazole (TMP-SMX). As an example, norfloxacin has been shown to be more effective for treating pyelonephritis than is TMP-SMX 8 -10 ; however, norfloxacin is significantly more expensive. Norfloxacin and TMP-SMX have, in the past, been recommended as outpatient medications for treating acute uncomplicated pyelonephritis in women, 3,4 but a trend of increasing resistance to TMP-SMX among Escherichia coli, especially among strains causing pyelonephritis, has been noted. 11,12The goal of this study was to consider how factors such as costs or quality of life might affect drug choices for treatment. We therefore developed a decision model to estimate the cost-effectiveness of alternative antibiotic strategies for women with acute uncomplicated pyelonephritis. For the purposes of t...

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“…Among those trials that determined bacterial susceptibilities after norfloxacin therapy [10][11][12][13][15][16][17], only one therapeutic failure was due to superinfection with a resistant group B streptococcal strain [16].…”

Section: Randomized Trials With Fluoroquinolones For the Treatment Ofmentioning

confidence: 99%

Comparative Studies of Fluoroquinolones in the Treatment of Urinary Tract Infections

Malinverni¹,

Glauser²

1988

Clinical Infectious Diseases

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The resultsof comparative trials of fluoroquinolones for the treatment of uncomplicated and complicated urinary tract infections (UTI) were reviewed. Severalrandomized, comparative trials showedthat in uncomplicated UTI norfloxacin, ciprofloxacin, and ofloxacin wereat least as effectiveas trimethoprim-sulfamethoxazole (TMP-SMZ) and amoxicillinand usually more effectivethan nalidixicacid, pipemidic acid, and nitrofurantoin. Comparativetrials of single-dose regimens have, however, been limited. A few randomized, comparative trials have shown that in complicated UTI norfloxacin, ciprofloxacin, and ofloxacin wereat least as effectiveas amoxicillinand TMP-SMZand usually more effective than pipemidic acid. Moreover, preliminary results indicate that fluoroquinolones might be effective for the oral treatment of complicated UTI that are difficult to treat, especially those due to Pseudomonas aeruginosa. Comparative trials are needed to establish the value of fluoroquinolones for chronic bacterial prostatitis. There are no conclusivedata on fluoroquinolone treatment of UTI in patients with renal failure. Emergence of resistantpathogens during therapywith fluoroquinolones has beeninfrequentbut might be more frequent in complicated UTI caused by P. aeruginosa.Although highly effective and well-established antibiotic regimens are available for the treatment of urinary tract infection (UTI), there is a need for new antimicrobial agents, especially for the treatment of outpatients with UTI that are difficult to treat and for which most of the drugs available for oral treatment are ineffective.The fluoroquinolones have several properties that suggest their potential clinical utility for the treatment of UTI, including high activity in vitro against virtually all urinary tract pathogens and good absorption after oral administration that results in prolonged high levels of drug in urine [1].The methodologic problems associated with open and comparative trials evaluating the efficacy of new antibiotics for the treatment of UTI have recently been reviewed [2]. For this review of the efficacy of fluoroquinolones for the treatment of UTI, we have emphasized those studies that have both sufficient data for a clear classification of UTI and data on We thank Mrs. Kathrin Zsirmik and Mrs. Alexandra Bloch for typing the manuscript.Please address requests for reprints to R. Malinverni, Medizinische Universitatsklinik, Inselspital, CH-3010 Bern, Switzerland. follow-up urine cultures 4-6 weeks after the end of treatment (unless otherwise mentioned). In this evaluation, bacteriologic cure (sterile urine) was considered as the end point of antibiotic treatment since the definitions of clinical response, when stated, varied from one study to another and symptoms may disappear in the absence of bacteriologic cure. In table 1, which outlines the efficacy of fluoroquinolone treatment of UTI by infecting organism, only data from studies (noncomparative and comparative) that provided sufficient information to permit a clear classification of UTI...

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Comparative trial of norfloxacin and trimethoprim-sulfamethoxazole in the treatment of women with localized, acute, symptomatic urinary tract infections and antimicrobial effect on periurethral and fecal microflora

Cited by 59 publications

References 26 publications

Prospective, randomized, placebo-controlled trial of norfloxacin for the prophylaxis of recurrent urinary tract infection in women

Prospective, randomized, placebo-controlled trial of norfloxacin for the prophylaxis of recurrent urinary tract infection in women

A Cost–Effectiveness Analysis of Treatment Strategies for Acute Uncomplicated Pyelonephritis in Women

Comparative Studies of Fluoroquinolones in the Treatment of Urinary Tract Infections

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