DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Soroka University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Optimization of Second Line Treatment Protocol for H Pylori Eradication

Intervention: Lansoprazole , Tab Amoxycillin , Tab Clarithromycin ,Tab Tinidazole (Drug); Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Soroka University Medical Center

Official(s) and/or principal investigator(s):
Daniela Munteanu, MD, Principal Investigator, Affiliation: Soroka UMC


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 .

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The eradication rate after second line treatment based on sequential therapy comparative to eradication rate after second line therapy based on quadriple regimen

Secondary outcome:

The secondary end points: Adverse effects of sequential and quadruple treatment

compliance with treatment

Detailed description: a total of 101 patients were randomized to 2 groups : 50 in sequential group and 51 patients in quadruple group . mean age was 43 in both groups. In sequential therapy group 42 patients(84%) completed the treatment , 39 patients returned to follow up . In quadruple group only 33 patients (64. 7%) completed the treatment , 29 of them returned to follow up. Compliance to the treatment was significant better in sequential group comparative to quadruple .Sides effects connected to gastro-intestinal tract were reported in 27(65. 9%) of quadruple group patients and in 19(43. 2%)of sequential group. The H pylori was eradicated in 23 of 39 patients in sequential group(59%), and in 19 of the 29 patients in quadruple group(65. 5%). no comorbidities like smoking, diabetes or other influenced the efficacy of eradication. Sequential therapy showed the same eradication rate as second line treatment of H pylori as quadruple one, but was associated with better compliance and less adverse effects. Both treatments protocols failed to show an appropriate eradication rate in population of Southern Israel .


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. signed informed consent 2. age at least 18 years 3. persisting H. pylori infection after at least one course of first-line standard triple therapy (Amoxycillin, Clarithromycin or Metronidazole based) Exclusion Criteria: 1. history of gastrectomy 2. gastric malignancy, including adenocarcinoma and lymphoma 3. previous allergic reaction to antibiotics (amoxicillin, clarithromycin, metronidazole, tetracycline) and proton pump inhibitors 4. Active upper gastrointestinal bleeding within the previous 1 week 5. contraindications to the treatment drugs 6. Pregnant or lactating women 7. Severe concurrent disease or malignancy

Locations and Contacts

Soroca UMC, Beer-Sheva, Israel
Additional Information

Starting date: November 2011
Last updated: July 5, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017