This multinational multi center randomized controlled trial designed to evaluate efficacy of Tetracycline + Levofloxacin for HP eradication.

During a six month period, all of the cases with HP infection in eight referral tertiary centers of three countries included and randomly allocate to receive either Tetracycline + Levofloxacin or clarithromycin base quadruple regimen for two weeks. Then pantoprazole continued for 4 more weeks and after one to two weeks of off therapy, they underwent UBT to prove eradication.

Overall 788 patients included (358 male (45.4%), average age 44.2y). They diagnosed as non-ulcer dyspepsia (516 cases, 65.5%), PUD (234 cases, 29.69%) and intestinal metaplasia (38 cases, 4.8%). The participants randomly allocated to groups A & B to receive either Tetracycline + Levofloxacin or clarithromycin. Among groups A and B in ITT and PP analysis, 75.2% & 82.1% (285 cases) and 67.5% & 70.1% (276 cases) of participants achieved eradication respectively (P = 0.0001). The complete compliance rate in group A & B were 84.4% and 83.6% respectively. During study, 33.5% of participants in group A (127 cases) reported side effects compare with 27.9% in group B (114 cases, P = 0.041). The most common complains among groups A and B were nausea and vomiting (12.6% & 9.3%) respectively. In sub group analysis, the eradication rate of Tetracycline + Levofloxacin among patients with non-ulcer dyspepsia, PUD and intestinal metaplasia were 79.4%%, 88.1% & 73.9% respectively. These figures in group B (clarithromycin base) were 71.3%, 67.6% & 61.5% respectively (P= 0.0001, 0.0001 & 0.043).

Overall, the combination of Tetracycline + Levofloxacin is more efficient for HP eradication in comparison with clarithromycin + Amoxicillin despite more complication rate and in areas with high rate of resistance to clarithromycin, this therapeutic regimen could be an ideal choice for HP eradication.