Reply to Kuehl et al
Year: 2017
Type: letter
Abstract: To the Editor—We appreciate the comments by Kuehl et al [1] regarding our strong recommendation against antibiotic prophylaxis in patients with basilar skull fracture and cerebrospinal fluid (CSF) leak [1, 2]. The current best available evidence, as shown in a Cochrane review, is a meta-analysis of 4 randomized clinical trials (RCTs) including a total of 208 patients who did not show an overall benefit of antibiotic prophylaxis in reducing the incidence of meningitis with an odds ratio 0.69, (95% confidence interval [CI], .29–1.61) [3]. As pointed out by Kuehl et al [1], the largest RCT of 109 patients, performed by Eftekhar et al [4], had some limitations; their meningitis rates were higher than expected, and the dose of ceftriaxone was lower than that currently recommended for the treatment of bacterial meningitis. Despite these concerns, the randomization process should have accounted for an even distribution of any confounding factors. The Cochrane review also provided a summary of nonrandomized studies that showed a benefit of antibiotic therapy with an odds ratio of 0.61 (95% CI, .37–.99). We chose to base our recommendations on the meta-analysis of the RCTs, because they would avoid bias or confounding. Furthermore, the upper CI of the meta-analysis was very close to 1 and nonsignificant. To appropriately answer this question and to assess any risks, an RCT with a large enough sample size to detect a difference would be the ideal approach. Ratilal et al [3] estimated that a sample size of 798 patients is needed to show a statistically significant result between the 2 interventions, with a power of 90% and the probability of a type I error of 5%. It would be very difficult to enroll enough patients for such a trial. In a recent study of 215 adults and children with healthcare-associated ventriculitis and meningitis seen at a large tertiary care center in Houston over an 11-year period, meningitis developed in only 7 (3.2%) after head trauma with a CSF leak [5]. Furthermore, Sonig et al [6], evaluating the national inpatient database in the United States from 2005 to 2009, found that posttraumatic CSF leaks are infrequent, reported in only 0.1%–0.2% of all head injury cases. Based on the current best available data, we continue our strong recommendation not to administer antibiotic prophylaxis in patients with basilar skull fracture and CSF leak. Potential conflicts of interest R. H. reports personal fees from Biomerieux, The Medicines Company, Pfizer, Biofire, and Merck, outside the submitted work. S. L. K. reports institutional grant support from Pfizer, Forest Laboratories, and Merck/Cubist, outside the submitted work. W. M. S. reports grants from the National Institutes of Health, Pfizer, and Wyeth, outside the submitted work. D. v. d. B. reports grants from the Netherlands Organization for Health Research and Development, the Netherlands Scientific Organization, the European Research Council, FP-7, Horizon 2020, and Omeros, and other support from GlaxoSmithKline, outside the submitted work. T. P. B. reports grants from Zoll, Sage, and EdgeCorp, outside the submitted work. A. R. T. reports personal fees from UpToDate, Elsevier, the American College of Physicians, and Merck, outside the submitted work. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
Source: Clinical Infectious Diseases
DOI: 10.1093/cid/cix985
Language: French
Subfield: Microbiology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W2768060453