Effects of a single oral dose of sparfloxacin on ventricular repolarization in healthy volunteers
Why the study?
Does a single oral dose of sparfloxacin prolong the QT interval in healthy volunteers?
Population
15 healthy volunteers
Comparison
Single oral doses of sparfloxacin (200 and 400 mg) vs Placebo
Design
RCT, Randomized, Double-blind
Follow-up
5 hours post-administration
Authors
Discussion
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Implication
Sparfloxacin use warrants QT monitoring in at-risk patients; extends direct RCT evidence on fluoroquinolone repolarization effects.
Structured PICO
Does a single oral dose of sparfloxacin prolong the QT interval in healthy volunteers?
P
Population
15 healthy volunteers
I
Intervention
Single oral doses of sparfloxacin (200 and 400 mg)
C
Comparator
Placebo
O
Outcome
QT interval at various heart rates (calculated at predetermined RR intervals of 1000, 800, 700, 600, 500 and 400 ms)surrogate
Single oral doses of sparfloxacin cause a mild (~4%) prolongation of the QT interval without significant reverse rate-dependence, suggesting it is unlikely to be associated with marked QT prolongation.
Cite This Study
Démolis et al. (1996) studied this question.