The Efficacy, Safety, and Tolerability of Levofloxacin Quadruple Therapy for Eradication: A Randomized, Double-Blind Clinical Trial.

The incidence of microbial resistance is growing, and new rescue regimens are needed to treat () infection. This study aimed to evaluate levofloxacin-based quadruple therapies' efficacy, safety, and tolerability in eradicating . In a randomized, double-blind clinical trial, 220 patients with dyspepsia and infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7) or ten days (BPAL-10). The eradication of was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention. According to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen at 49.1% (95% CI: 39.3-57.8) and 47.6% (95% CI: 39.7-58.4), respectively, compared to the BPAL-10 regimen at 62.7% (95% CI: 53.6-72.8) and 62.4% (95% CI: 55.1-72.8), respectively. The ADR incidence was not statistically significant between the groups of BPAL-7 (33.6%) and BPAL-10 (36.7%). Although the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for because of their low eradication rates compared to standard regimens. . The study was reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19).