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
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 .
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 treatmentcompliance 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 .
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
|