Single Dose Oral Administration of Cefixime 400mg in the Treatment of Acute Uncomplicated Cystitis and Gonorrhoea

Asbach, H. W.

doi:10.2165/00003495-199100424-00005

Cited by 30 publications

(13 citation statements)

References 8 publications

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“…In a recently published meta-analysis on antibiotic versus placebo treatment of women with uncomplicated cystitis by Falagas and co-workers [7] amongst systematic literature searches in the PubMed database, Cochrane Central Register of Controlled Trials (both up to 7 November 2008), and Scopus (up to 12 November 2008) as well as by hand-searching the bibliographies of relevant articles, five individual RCTs were considered as eligible for inclusion in their meta-analysis [11][12][13][14][15]. All five RCTs enrolled adult women with clinical symptoms suggestive of a lower UTI.…”

Section: Natural History and Placebo-controlled Studiesmentioning

confidence: 99%

Antibiotic treatment of uncomplicated urinary tract infection in premenopausal women

Naber

Wullt

Wagenlehner

2011

International Journal of Antimicrobial Agents

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Section: Natural History and Placebo-controlled Studiesmentioning

confidence: 99%

Antibiotic treatment of uncomplicated urinary tract infection in premenopausal women

Naber

Wullt

Wagenlehner

2011

International Journal of Antimicrobial Agents

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“…21e25 Three out of the 5 RCTs enrolled adult women, specifically age ranged between 18 and 84 years among these 3 RCTs. 21,23,24 Regarding the remaining 2 included RCTs, the age of the enrolled women ranged from 15 to 75 years. 22,24 All 5 RCTs enrolled adult women with clinical symptoms suggestive of a lower urinary tract infection.…”

Section: Characteristics Of the Included Populationsmentioning

confidence: 99%

“…21,23 Specifically, in 1 out of these 2 RCTs, the patients allocated in all 3 antibiotic treatment groups were treated with the same antibiotic agent but according to different dosage schedules, 21 whereas in the other study, the patients allocated in the 3 antibiotic-treated groups were treated with different antibiotic agents and with different dosage schedules. 23 In the remaining RCTs the antibiotic-treated patients were allocated in 2 groups and were treated with different antibiotic agents. 24 Regarding the duration of antibiotic treatment, in 2 of the 5 included RCTs patients received a single dose of antibiotic treatment, 23,24 in 1 RCT patients received a 3-day antibiotic course, 22 whereas in the remaining 2 RCTs patients received a 7-day antibiotic course, 21,25 with the exception of the patients in 1 out of these 2 studies that were allocated in a 3-day antibiotic course, followed by 4 days of placebo treatment.…”

Section: Antimicrobial Regimensmentioning

confidence: 99%

Antibiotics versus placebo in the treatment of women with uncomplicated cystitis: A meta-analysis of randomized controlled trials

Falagas

Kotsantis

Vouloumanou

et al. 2009

Journal of Infection

120

106

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“…We conducted a systematic literature search for such reports of inappropriate or inadequate treatment of uUTI or cUTI in PubMED and EMBASE, using combinations of the following search terms: "inappropriate treatment," "inadequate treatment," "delayed treatment," and "urinary tract infection"; no publications were identified. For assessment of inappropriate antimicrobial treatment in cUTI, trials were restricted to three publications reported in the FDA guidance for noninferiority trial assessment of cUTI and the final selection of trials included in the meta-analysis from our systematic review (12,(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34).…”

Section: Methodsmentioning

confidence: 99%

“…The screening process resulted in the exclusion of 453 of the publications from PubMed and 2,296 searches from EMBASE, resulting in seven nonduplicate, eligible publications (21)(22)(23)(24)(38)(39)(40). Four of these seven eligible publications met the final inclusion criteria (Table 1), with full review of the study by Dubi et al after certified translation of the publication from French into English (21)(22)(23)(24). The estimated microbiological eradication was 31.8% (95% CI, 26.5% to 37.2%) among 291 subjects in four uUTI trials.…”

Section: Placebo Treatment Effect In Urinary Tract Infectionsmentioning

confidence: 99%

Systematic Review and Meta-Analysis of Antimicrobial Treatment Effect Estimation in Complicated Urinary Tract Infection

Singh

Mitrani-Gold

et al. 2013

Antimicrob Agents Chemother

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bNoninferiority trial design and analyses are commonly used to establish the effectiveness of a new antimicrobial drug for treatment of serious infections such as complicated urinary tract infection (cUTI). A systematic review and meta-analysis were conducted to estimate the treatment effects of three potential active comparator drugs for the design of a noninferiority trial. The systematic review identified no placebo trials of cUTI, four clinical trials of cUTI with uncomplicated urinary tract infection as a proxy for placebo, and nine trials with reports of treatment effect estimates for doripenem, levofloxacin, or imipenem-cilastatin. In the meta-analysis, the primary efficacy endpoint of interest was the microbiological eradication rate at the test-of-cure visit in the microbiological intent-to-treat population. The estimated eradication rates and corresponding 95% confidence intervals (CI) were 31.8% (26.5% to 37.2%) for placebo, 81% (77.7% to 84.2%) for doripenem, 79% (75.9% to 82.2%) for levofloxacin, and 80.5% (71.9% to 89.1%) for imipenem-cilastatin. The treatment effect estimates were 40.5% for doripenem, 38.7% for levofloxacin, 34.7% for imipenem-cilastatin, and 40.8% overall. These treatment effect estimates can be used to inform the design and analysis of future noninferiority trials in cUTI study populations. Complicated urinary tract infections (cUTI) occur in persons with structural or functional abnormalities of the urinary tract and in hospitalized patients with significant medical or surgical comorbidities (1, 2). These infections are a major cause of hospital admission, morbidity, mortality, and excess health care costs (3-6). National and international treatment guidance for urinary tract infections includes recommendations for targeted and empirical treatment of the major causative pathogens, including Escherichia coli, Klebsiella pneumoniae, and non-Enterobacteriaceae organisms such as Pseudomonas aeruginosa (7-9).Of notable concern for the clinical care of patients with cUTI and other serious infections is effective antimicrobial treatment amid the emergence and spread of drug-resistant pathogens (10, 11). To demonstrate efficacy of a new or test antimicrobial agent for the treatment of adult subjects with cUTI, randomized parallel-group noninferiority phase 3 trials have traditionally been used to meet regulatory requirements for approval of the test drug (12). An active-comparator, noninferiority study design is generally used in cUTI trials given the ethical implications of placebo treatment (13,14). In order to conduct a noninferiority trial, an estimate of the treatment effect of the planned antimicrobial comparator must be obtained from historical data (12). Once an estimate of the treatment effect of the antimicrobial comparator is determined, the largest clinically acceptable difference of the test drug compared to the comparator must be decided. This decision is critical to the design, analysis, and interpretation of a noninferiority trial.We conducted a systematic review and me...

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Single Dose Oral Administration of Cefixime 400mg in the Treatment of Acute Uncomplicated Cystitis and Gonorrhoea

Cited by 30 publications

References 8 publications

Antibiotic treatment of uncomplicated urinary tract infection in premenopausal women

Antibiotic treatment of uncomplicated urinary tract infection in premenopausal women

Antibiotics versus placebo in the treatment of women with uncomplicated cystitis: A meta-analysis of randomized controlled trials

Systematic Review and Meta-Analysis of Antimicrobial Treatment Effect Estimation in Complicated Urinary Tract Infection

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