CompletedPhase 3

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

Israel101 participantsStarted 2011-11

Plain-language 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 .

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. signed informed consent
✓. age at least 18 years
✓. persisting H.pylori infection after at least one course of first-line standard triple therapy (Amoxycillin, Clarithromycin or Metronidazole based)

Exclusion criteria

✕. history of gastrectomy
✕. gastric malignancy, including adenocarcinoma and lymphoma
✕. previous allergic reaction to antibiotics (amoxicillin, clarithromycin, metronidazole, tetracycline) and proton pump inhibitors
✕. Active upper gastrointestinal bleeding within the previous 1 week
✕. contraindications to the treatment drugs
✕. Pregnant or lactating women
✕. Severe concurrent disease or malignancy

What they're measuring

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

Timeframe: 18 month

Trial details

NCT IDNCT01481844

SponsorSoroka University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

View on ClinicalTrials.gov More Optimization of Second Line Treatment Protocol for H Pylori Eradication trials