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

Optimization of Second Line Treatment Protocol for H Pylori Eradication Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481844
• Other study ID #: sor006811ctil
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2011
• Last updated: July 5, 2015
• Start date: November 2011
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Optimization of Second Line Treatment Protocol for H Pylori Eradication

Intervention

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
• Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline
this combination is standard of care as H pylori second line treatment

Locations

Country	Name	City	State
Israel	Soroca UMC	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The eradication rate after second line treatment based on sequential therapy comparative to eradication rate after second line therapy based on quadriple regimen	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).	18 month	Yes
Secondary	The secondary end points: Adverse effects of sequential and quadruple treatment	-Adverse effects -taste alteration , peripheral neuropathy, seizures, nausea, vomiting, diarrhea, abdominal pain, allergic reaction, photo sensibility-checked at clinical visit by direct question.	18 months	Yes
Secondary	compliance with treatment	compliance is considered to be satisfactory when drug intake exceeded 80 %( by pills count).	18 months	No