Comparison of Two Rescue Therapies for Helicobacter Pylori Infection

NCT02547012 | Completed Results DMC

• 1 other identifier: VGHKS13-CT11-15
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Eradication rate; Rescue treatment

Outcome Measures

Primary Outcomes (1)

• Number of Participants in Which H. Pylori Was Eradicated

  Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

  six weeks after the end of anti-H pylori therapy.

Study Arms (2)

esomeprazole+amox+levo+tetra

EXPERIMENTAL

esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.

Drug: esomeprazole+amox+levo+tetra

esomeprazole+amox+levo

ACTIVE COMPARATOR

esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.

Drug: esomeprazole+amox+levo

Interventions

esomeprazole+amox+levo+tetra DRUG

esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.

Also known as: esomeprazole 40mg, amoxicillin 500 mg, levofloxacin 500 mg, tetracycline 500 mg

esomeprazole+amox+levo+tetra

esomeprazole+amox+levo DRUG

esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,

Also known as: esomeprazole 40 mg, amoxicillin 500 mg, levofloxacin 500 mg

esomeprazole+amox+levo

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• positive results of both rapid urease test and histology,
• a positive result of urea breath test,
• or a positive result of culture.

You may not qualify if:

• ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）within the prior 4 weeks,
• patients with allergic history to the medications used,
• patients with previous gastric surgery,
• the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
• pregnant women

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (31)

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MeSH Terms

Interventions

Esomeprazole; Amoxicillin; Levofloxacin; Tetracycline

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

The trial was performed in a single country

Results Point of Contact

• Title: Dr. Ping-I Hsu
• Organization: Kaohsiung Veterans General Hospital

pihsu@vghks.gov.tw

+886-7-3422121

Study Officials

• Ping-I Hsu, Bachelor

  Kaohsiung Veterans General Hospital.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2015
• First Posted: September 11, 2015
• Study Start: November 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 14, 2019
• Results First Posted: March 14, 2019

Record last verified: 2019-03

Locations

TW (1)