Sequential Therapy Versus Quadruple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection

Phase 3 Completed 101 enrolled Soroka University Medical Center

RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI + amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and tinidazole ) versus quadruple drug regimen( i.e.-14 days of PPI+ bismuth + metronidazole + tetracycline ) as second line treatment of H. pylori .

Timeline

Start: 2011-11
Primary completion: 2014-12
Completion: 2014-12

Outcome

Met primary endpoint

paper eradication rate was 49% in the sequential versus 42.5% in the quadruple regimen group (p-value for non-inferiority 0.02). PMID 28957341 ↗

Publications

Munteanu D, Etzion O, Ben-Yakov G, Halperin D, Eidelman L, Schwartz D, Novack V, Abufreha N, Krugliak P, Rozenthal A, Gaspar N, Moshkalo A, Dizingof V, Fich A. Efficacy and safety of sequential versus quadruple therapy as second-line treatment for helicobacter pylori infection-A randomized controlled trial. PLoS One. 2017 Sep 28;12(9):e0183302. doi: 10.1371/journal.pone.0183302. eCollection 2017.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amoxicillin	Other / unclassified	1 g	—
Comparator	Bismuth subsalicylate	Small molecule	525 mg	—
Subject	Clarithromycin	Small molecule	500 mg	—
Subject	Lansoprazole	Other / unclassified	30 mg	—
Comparator	Metronidazole	Small molecule	500 mg	—
Comparator	Tetracycline	Unknown	500 mg	—
Subject	tinidazole	Small molecule	500 mg	—

Indications

No indication recorded.