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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniela Munteanu,MD ,Principal Investigator, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01481844
First received: October 30, 2011
Last updated: July 5, 2015
Last verified: July 2015
  Purpose

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 .


Condition Intervention Phase
Optimization of Second Line Treatment Protocol for H Pylori Eradication
Drug: Lansoprazole , Tab Amoxycillin , Tab Clarithromycin ,Tab Tinidazole
Drug: Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • The eradication rate after second line treatment based on sequential therapy comparative to eradication rate after second line therapy based on quadriple regimen [ Time Frame: 18 month ] [ Designated as safety issue: Yes ]
    H pylori eradication is defined as a negative C-urea breath test 4-16 weeks after completion of tratment.]. (C-urea breath test- Patients are fasted for 4 h before testing. No test meal will be given, and a pre-dose breath sample is obtained. 75 mg of 13C-urea powder dissolved in 50 mL of water is then administered orally, and a second breath sample is collected 30 minutes later. Collected samples are analyzed using an isotope ratio mass spectrometer).


Secondary Outcome Measures:
  • The secondary end points: Adverse effects of sequential and quadruple treatment [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    -Adverse effects -taste alteration , peripheral neuropathy, seizures, nausea, vomiting, diarrhea, abdominal pain, allergic reaction, photo sensibility-checked at clinical visit by direct question.

  • compliance with treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    compliance is considered to be satisfactory when drug intake exceeded 80 %( by pills count).


Enrollment: 101
Study Start Date: November 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sequential treatment
1.drugs experimental-Sequential -PPI( Lansoprazole 30mg x2/day) + amoxicillin 1gx2/day for 5days, followed by 5 days of PPI(Lansoprazole 30mg x2/day) + ( Clarithromycin500mg x2/day and Tinidazole 500mg x2/day )
Drug: Lansoprazole , Tab Amoxycillin , Tab Clarithromycin ,Tab Tinidazole
use of Sequential therapy as second line treatment for eradication H pylori currently Sequential therapy is indicated as first line treatment for H pylori eradication
Active Comparator: quadruple therapy
Quadruple drug regimen (i.e.-14 days of PPI (Lansoprazole 30mg x2/day) + Bismuth Subsalicylate 525mg X4/day + Metronidazole 500mg x3/day + Tetracycline 500mg x4/day )-is standard of care as second line treatment in eradication of H pylori
Drug: Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline
this combination is standard of care as H pylori second line 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01481844

Locations
Israel
Soroca UMC
Beer-Sheva, Israel
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Daniela Munteanu, MD Soroka UMC
  More Information

No publications provided

Responsible Party: Daniela Munteanu,MD ,Principal Investigator, MD, Principal investigator, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01481844     History of Changes
Other Study ID Numbers: sor006811ctil
Study First Received: October 30, 2011
Last Updated: July 5, 2015
Health Authority: Israel: Ethics Commission

Keywords provided by Soroka University Medical Center:
sequential therapy
second line treatment
H pylori

Additional relevant MeSH terms:
Amoxicillin
Bismuth subsalicylate
Clarithromycin
Dexlansoprazole
Lansoprazole
Metronidazole
Tetracycline
Tinidazole
Alkylating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Antidiarrheals
Antiparasitic Agents
Antiprotozoal Agents
Antitrichomonal Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Proton Pump Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 31, 2015