A comparative study of levofloxacin-based versus clarithromycin-based triple therapy for first-line Helicobacter pylori eradication in Iran

Background Rising clarithromycin resistance in Iran necessitates the evaluation of alternative first-line Helicobacter pylori regimens. Helicobacter pylori is a primary cause of peptic ulcer disease and gastric cancer, making its effective eradication a global health priority. This study aimed to compare the efficacy, safety, and patient adherence of a levofloxacin-based triple therapy with the standard clarithromycin-based regimen. Aims This study aimed to compare the efficacy, safety, and patient adherence of a levofloxacin-based triple therapy against the standard clarithromycin-based triple therapy for the first-line eradication of Helicobacter pylori in an Iranian patient population. Methods This non-randomized, non-parallel, open-label clinical trial was conducted at Imam Khomeini Hospital complex affiliated with Tehran University of Medical Sciences, Tehran, Iran. Adults who were aged 18 to 65 years treatment-naïve patients with confirmed H. pylori infection based on a positive fecal Ag test were sequentially enrolled to receive either a 10-day regimen of levofloxacin, amoxicillin, and omeprazole (n = 61) or clarithromycin, amoxicillin, and omeprazole (n = 65). Eradication was confirmed by a fecal antigen test. Results Of 126 patients, 91 completed the final follow-up for per-protocol (PP) analysis. In the PP analysis, eradication rates were 81.6% (31/38) for the levofloxacin group and 66.0% (35/53) for the clarithromycin group (P = .101). In the intention-to-treat (ITT) analysis of all 126 patients, rates were 50.8% and 53.8%, respectively (P = .734). The incidence of side effects was similar (44.2% vs. 44.4%), though constipation was more frequent with levofloxacin (P = .017) and halitosis with clarithromycin (P = .022). Conclusion The levofloxacin-based regimen did not demonstrate statistically significant superiority over the clarithromycin-based regimen. With comparable safety and suboptimal efficacy for both regimens, these findings underscore the need for local resistance surveillance to guide first-line therapy. Trial Registration Iranian Registry of Clinical Trials, IRCT20210209050313N1. Registered on 200210520