The Effects of Moxifloxacin and Gemifloxacin on the ECG Morphology in Healthy Volunteers: A Phase 1 Randomized Clinical Trial
Abstract
Moxifloxacin and gemifloxacin are the two newer broad-spectrum 8-methoxy-quinolone derivatives that are used to treat various bacterial infections in cardiac patients. In this research study, we assessed the impact of moxifloxacin and gemifloxacin on the QT intervals of electrocardiograms in normal adult doses and draw a comparison, in a controlled environment, on healthy volunteers. Additionally, the effect of both test drugs on the QRS complex was checked. Sixty healthy volunteers were randomly assigned to two groups via R-software, and each respectively received moxifloxacin and gemifloxacin for five days. The research ethics committee approved the research, and it was registered for clinical trial under NCT 04692623. The participants’ electrocardiograms were obtained before the start of the dose (baseline) and on the fifth day. Significant prolongation of QT interval was noted in moxifloxacin (p < 0.0001) as compared to gemifloxacin treated groups. There were no cases of QTc prolongation over the usual limits (450–470 ms) in the gemifloxacin-treated group, however, QTc prolongations at the rate of 30 and 60 ms from the baseline were noted, interpreted as per the EMEA guidelines. These findings indicate that moxifloxacin caused significant (p < 0.0001) QT interval prolongation (QTIP) as compared to gemifloxacin. In contrast to the previously reported literature, the prominent effect of moxifloxacin on the widening of the QRS-complex was noted with no such effect on…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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