Systematic Review and Meta-analysis to Estimate the Antibacterial Treatment Effect of Nitrofurantoin for a Non-Inferiority Trial in Uncomplicated Urinary Tract Infection
Abstract
OBJECTIVES
Active-comparator, non-inferiority study designs are used in uncomplicated urinary tract infection (uUTI) to establish the efficacy of a new antibacterial, given the availability of effective antibiotics. We estimate the treatment effect of a planned antimicrobial comparator (nitrofurantoin), from historical trial data, to properly design an upcoming non-inferiority study in uUTI.
METHODS
A systematic literature review and meta-analysis were conducted in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines which incorporate recommendations for standardized data quality assessment, reporting of results, risk of bias assessment and sensitivity analyses. To account for inter-study variability, a weighted non-iterative, random effects model was fit, using R software to obtain estimates of the microbiological response rate and corresponding 95% CI for nitrofurantoin and placebo treatment. Inter-study heterogeneity was assessed, with Cochran's chi-square test for inter-study heterogeneity; I2 statistic and P values were computed and included in the forest plot of the meta-analysis.
RESULTS
Twelve unique studies met the final eligibility criteria for meta-analysis inclusion; 3 trials assessed placebo efficacy, 8 trials assessed nitrofurantoin efficacy, and one study assessed both nitrofurantoin and placebo efficacy in uUTI. The overall microbiological response (95% confidence interval) was 0.766 (0.665, 0.867) for…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.
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