Research Question

Is ciprofloxacin 750 mg administered enterally a clinically feasible alternative to ciprofloxacin 400 mg administered intravenously for adults receiving enteral feeds?

Hierarchy of Clinical Outcomes

In descending order of importance, the clinical outcomes of interest were death, serious adverse events, clinical cure, microbiological cure, re-infection, total adverse events, ratio of AUC to minimum inhibitory concentration (MIC), ratio of Cmax to

MIC, and Cm„.Data Extraction

The review was undertaken by all 3 authors (D.C., L.C., A.T.). Two of the authors (L.C., A.T.) independently searched the literature and screened the articles to identify studies that satisfied the inclusion criteria. The same 2 authors extracted the data using a standardized data extraction form; the third author (D.C.) was consulted to resolve discrepancies.
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Inclusion Criteria

To be included in this review, studies had to be full reports of published, randomized controlled trials in which patients were randomly assigned to receive either ciprofloxacin 750 mg enterally or ciprofloxacin 400 mg intravenously in the presence of enteral feeding (i.e., feeds administered through a nasojejunal, nasoduodenal, nasogastric, or an orogastric tube). For the specified study question, a randomized controlled trial with parallel groups comparing 750 mg given enterally with 400 mg given intravenously, with reporting of clinical outcomes, was considered ideal. If no trials with clinical outcomes were found, randomized cross-over trials were included, because partici­pants in a cross-over trial serve as their own controls. As such, confounding of results due to interindividual variability in pharmacokinetic parameters would be minimized. In addition, included trials must have reported on at least one of the prespecified outcomes (as stated above).

Participants

Patients had to be adults admitted to hospital with any acute infection requiring ciprofloxacin therapy. Trials involving healthy volunteers were excluded, as the primary focus of this systematic review was the effect of different doses on clinical outcomes. In addition, the pharmacodynamic and pharmacokinetic effects of drugs differ between patients with acute illness and healthy volunteers.
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Searches

Searches were conducted in EMBASE (January 1, 1980, to April 28, 2008) and MEDLINE (January 1, 1949, to April 28, 2008). No language restrictions were applied. The following key words were used: “ciprofloxacin”, “fluoroquinolone”, “tube feed”, and “enteral”. In addition, the reference lists of trials that underwent full-text review were hand-searched to identify additional trials.