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Helicobacter pylori infection is a predisposing factor for gastric cancer. This prospective, randomized clinical trial aimed to compare H. pylori eradication rates associated with a clarithromycin-based regimen and levofloxacin-based regimen. H. pylori infection was confirmed by a rapid urease test during endoscopy and its eradication by a urea breath test. In this study, 192 patients were recruited; 93 patients received a clarithromycin-based regimen and 99 a levofloxacin-based regimen. Sixty-four patients completed the clarithromycinbased regimen and 60 the levofloxacinbased regimen. The eradication success rate of the clarithromycin-based regimen was 52/64 (81.25%), while that of the levofloxacin-based regimen was 49/60 (81.6%) (P=0.9524; odds ratio [OR]=1.0280; confidence interval [CI]=0.4153-2.5447). Investigation of the risk factors associated with treatment failure showed that the overall efficacy of the regimens was influenced by body mass index (BMI), with a high failure rate observed in patients with a high BMI (P=0.0174; OR=1.1116; CI=1.01871.2129). Age, sex, endoscopic diagnosis and smoking did not influence treatment outcomes. Further studies are needed to monitor H. pylori antibiotic resistance rates. Introduction Helicobacter pylori is a Gram-negative microaerophilic bacterium,1 the discovery of which changed the mainstream understanding of gastric diseases, particularly peptic ulcer.1 Infection with H. pylori predisposes one to gastric cancer – the third most commonly occurring cause of cancerrelated death.2 A total of 50% of the world’s population has H. pylori infection,3 with a prevalence rate of 20% in developed countries and 80% in developing countries.3 While several regimens have been considered for H. pylori eradication, the failure rates associated with eradication are high, varying across countries. With the increased prevalence of antibiotic resistance, H. pylori eradication represents a challenge. Different variables such as patient characteristics, underlying disease presence and environmental factors also play an important role in treatment failure. Triple therapy, comprising amoxicillin and clarithromycin plus a proton pump inhibitor, is the most commonly used first-line regimen recommended for the eradication of H. pylori.4 However, owing to increases in the rates of H. pylori resistance to clarithromycin, the efficacy of this regimen has been progressively decreasing.4 Levofloxacin – a fluoroquinolone – was then proposed as an effective and safe second-line medication for the eradication of this bacterium.5 In a study conducted in Iraq that used molecular methods to detect both clarithromycin and levofloxacin resistance, 16.2% of the strains were resistant to clarithromycin, while 4% were resistant to levofloxacin.6 No study in Iraq has investigated the eradication success rates associated with the clarithromycin and levofloxacin-based regimens. This study was conducted to investigate the eradication success rate of these two regimens and identify the risk factors associated with H. pylori eradication failure. Materials and Methods Study design and patients We conducted a prospective, randomized clinical trial between July 2018 and March 2019 at the Gastrointestinal Disease Center of the Azadi Teaching Hospital, Duhok, Kurdistan Region of Iraq. Patients’ H. pylori infection status was confirmed using a rapid urease test during endoscopy. The inclusion criteria for patient recruitment were: H. pylori-positivity, age 18 years and older, and provision of consent for recruitment. Exclusion criteria included: prior antibiotic use, age younger than 18 years, pregnancy, and the absence of consent for participation. At the end of the study, eradication success rate was determined using intention-to-treat and per-protocol analyses.

Clarithromycin versus levofloxacin-based regimens for Helicobacter pylori eradication in the Kurdistan Region of Iraq: A randomized clinical trial