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

NCT ID: NCT01481844

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-12-31

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 .

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 .

Conditions

Optimization of Second Line Treatment Protocol for H Pylori Eradication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 )

Group Type: EXPERIMENTAL

Lansoprazole , Tab Amoxycillin , Tab Clarithromycin ,Tab Tinidazole

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline

Intervention Type: DRUG

this combination is standard of care as H pylori second line treatment

Interventions

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

Intervention Type: DRUG

Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline

this combination is standard of care as H pylori second line treatment

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soroka University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Daniela Munteanu,MD ,Principal Investigator

MD, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela Munteanu, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka UMC

Locations

Soroca UMC

Beersheba, , Israel

Countries

Israel

References

Munteanu D, Etzion O, Ben-Yakov G, Halperin D, Eidelman L, Schwartz D, Novack V, Abufreha N, Krugliak P, Rozenthal A, Gaspar N, Moshkalo A, Dizingof V, Fich A. Efficacy and safety of sequential versus quadruple therapy as second-line treatment for helicobacter pylori infection-A randomized controlled trial. PLoS One. 2017 Sep 28;12(9):e0183302. doi: 10.1371/journal.pone.0183302. eCollection 2017.

Reference Type: DERIVED

PMID: 28957341 (View on PubMed)

Other Identifiers

sor006811ctil

Identifier Type: -

Identifier Source: org_study_id