Background: Eradicating Helicobacter pylori (H. pylori) infection is challenging because of increasing prevalence of antibiotic-resistant H. pylori infection. There is scanty data in India that assessed the efficacy of levofloxacin containing regimen as first line therapy against H. pylori infection. 

Aim: This study was to evaluate the efficacy and tolerability of a 2-week course of levofloxacin, amoxicillin and proton pump inhibitor (PAL regimen) as first-line treatment against H pylori infection. 

Methods: This was an open-label, prospective study. Patients with H. pylori infection were treated with amoxicillin (1000 mg twice daily), levofloxacin (500 mg once daily) and esomeprazole (40 mg twice daily) for 14 days. Eradication of H. Pylori infection was assessed 4 - 6 weeks after completion of therapy. H. pylori eradication was assessed by either gastric biopsy or stool antigen assay. Treatment compliance and adverse effects were also evaluated. 

Results: Out of 131 patients who entered into study for final analysis, H. pylori eradication was achieved in 83.97%;95% CI:78–90 (110 out of 131) patients in per protocol analysis and 81.48%;95% CI:75-88 (110 out of 135) patients in intention to treat analysis. 98.5% patients were compliant to therapy. Adverse effects were reported in 18 %, mostly were mild in nature. 

Conclusion: PAL regimen as first-line therapy to eradicate H. pylori infection is found to be effective, compliant and well tolerated. It could be used as alternative first line regimen especially in area of high dual clarithromycin and metronidazole resistance.