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Trial record 46 of 201 for:    TETRACYCLINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01481844
Recruitment Status : Completed
First Posted : November 30, 2011
Last Update Posted : July 8, 2015
Information provided by (Responsible Party):
Daniela Munteanu,MD ,Principal Investigator, Soroka University Medical Center

Brief 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 .

Condition or disease Intervention/treatment 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

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. The secondary end points: Adverse effects of sequential and quadruple treatment [ Time Frame: 18 months ]
    -Adverse effects -taste alteration , peripheral neuropathy, seizures, nausea, vomiting, diarrhea, abdominal pain, allergic reaction, photo sensibility-checked at clinical visit by direct question.

  2. compliance with treatment [ Time Frame: 18 months ]
    compliance is considered to be satisfactory when drug intake exceeded 80 %( by pills count).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01481844

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Daniela Munteanu,MD ,Principal Investigator, MD, Principal investigator, Soroka University Medical Center Identifier: NCT01481844    
Other Study ID Numbers: sor006811ctil
First Posted: November 30, 2011    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015
Keywords provided by Daniela Munteanu,MD ,Principal Investigator, Soroka University Medical Center:
sequential therapy
second line treatment
H pylori
Additional relevant MeSH terms:
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Bismuth subsalicylate
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Alkylating Agents
Antitrichomonal Agents