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Volunteers were advised to avoid exposure to sunlight throughout the treatment period. The study design was approved by the local ethics committee of Paris Bichat-Cergy Pontoise.

Abstract Background The treatment of enteric randomised trial.

All participants gave written informed consent before entering the study. Regimens Volunteers were randomly assigned into 6 groups of 8 individuals each, receiving either 250 mg of oral ciprofloxacin every 12 h, 500 mg every 24 h, 500 mg every 12 h, 750 mg every 24 h, 750 mg every 12 h, or 1000 mg every 24 h for a total of 14 days.

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These regimens were chosen to generate pharmacokinetic variability across a range of clinically relevant total daily doses. Each intake was observed and its time recorded. The analysis focused on viridans group streptococci VGS in the pharyngeal flora and Escherichia coli in the fecal flora for the following reasons: these bacterial species are present in all subjects, they are involved in various clinical infections bacteremia, endocarditis, and urinary tract infections, and they are recognized sources of horizontal gene transfer within the commensal flora.

For each target species, we determined the susceptibility to quinolones in the global population dominant flora and the emergence of quinolone-resistant subpopulations subdominant flora.

Detection of ciprofloxacin susceptibility in the dominant flora We used a procedure specifically designed to estimate susceptibility of the dominant flora as a whole to fluoroquinolones.

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After growth, we isolated 10 separate colonies from each plate, identified as VGS and E. These 10 colonies were mixed, and susceptibility to fluoroquinolones was tested for the mixture as described elsewhere, using MICs in duplicate by the agar dilution method and MPCs in triplicate.

Geometric means of these replicates were used in the analysis. MICs of the colonies growing on selective media were determined by the agar dilution method. End points Resistance to nalidixic acid and ciprofloxacin among E.


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Briefly, participants were reviewed without in an outpatient setting for two-weeks following concomitant challenge.
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Emergence of resistance was defined by the detection of resistant strains at day 7, 14, or 42 in subjects in whom only susceptible strains were detected and resistant strains were not detected before treatment.

Pharmacokinetic Follow-up Study Serum and saliva samples were taken from each volunteer before and 1, 6, and 12 h after receipt of the first ciprofloxacin dose; at trough on days 8 and 14; and again 1, 6, and 12 h after the last dose.

Stool samples were collected on days 0, 14, and 42.

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Ciprofloxacin concentrations were determined by liquid chromatography with fluorimetric detection after deproteinization or stool extraction in acidic medium, as described elsewhere.

Statistical Analysis A population pharmacokinetic analysis with, as previously described, a 1-compartment model with first-order absorption was used to analyze plasma and saliva concentrations and estimate the maximal concentration peak and AUC from 0 to 24 h at steady state for each volunteer, taking into account the dosing schedule.


These studies found no evidence of the cartilaginous pathology described in the original fluoroquinolone animal studies do 1.
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Confidence intervals CIs for the percentages of subjects in whom resistance emerged among bacteria were estimated using the binomial distribution. For each target flora, the volunteers were divided into 2 groups regardless of the dosage according to the emergence or nonemergence of resistance.

Subjects, Materials, and Methods

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  • None reported pathologic changes detected as a direct effect of therapy.
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  • Conclusions based on a literature review of fluoroquinolone-associated adverse events are also limited by the reality that a clinical trial is unlikely to have adequate power to detect a rare and serious adverse event.
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