Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue Treatment of H Pylori Infection

NCT02978157 | Completed Results DMC

• 1 other identifier: VGHKS104-062
• Study Type: interventional
• Target: 102
• 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

  Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication

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

Study Arms (2)

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

esomeprazole+bismuth+tetra+levo

EXPERIMENTAL

esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

Drug: esomeprazole+bismuth+tetra+levo

Interventions

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

esomeprazole+bismuth+tetra+levo DRUG

esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

Also known as: esomeprazole 40mg, bismuth 120 mg, tetracycline 500 mg, levofloxacin 500 mg

esomeprazole+bismuth+tetra+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 (17)

• Suerbaum S, Michetti P. Helicobacter pylori infection. N Engl J Med. 2002 Oct 10;347(15):1175-86. doi: 10.1056/NEJMra020542. No abstract available.

  PMID: 12374879 BACKGROUND

• Zucca E, Dreyling M; ESMO Guidelines Working Group. Gastric marginal zone lymphoma of MALT type: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2009 May;20 Suppl 4:113-4. doi: 10.1093/annonc/mdp146. No abstract available.

  PMID: 19454427 BACKGROUND

• Asaka M, Kato M, Takahashi S, Fukuda Y, Sugiyama T, Ota H, Uemura N, Murakami K, Satoh K, Sugano K; Japanese Society for Helicobacter Research. Guidelines for the management of Helicobacter pylori infection in Japan: 2009 revised edition. Helicobacter. 2010 Feb;15(1):1-20. doi: 10.1111/j.1523-5378.2009.00738.x.

  PMID: 20302585 BACKGROUND

• Fock KM, Katelaris P, Sugano K, Ang TL, Hunt R, Talley NJ, Lam SK, Xiao SD, Tan HJ, Wu CY, Jung HC, Hoang BH, Kachintorn U, Goh KL, Chiba T, Rani AA; Second Asia-Pacific Conference. Second Asia-Pacific Consensus Guidelines for Helicobacter pylori infection. J Gastroenterol Hepatol. 2009 Oct;24(10):1587-600. doi: 10.1111/j.1440-1746.2009.05982.x.

  PMID: 19788600 BACKGROUND

• Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4.

  PMID: 20525969 BACKGROUND

• Gumurdulu Y, Serin E, Ozer B, Kayaselcuk F, Ozsahin K, Cosar AM, Gursoy M, Gur G, Yilmaz U, Boyacioglu S. Low eradication rate of Helicobacter pylori with triple 7-14 days and quadriple therapy in Turkey. World J Gastroenterol. 2004 Mar 1;10(5):668-71. doi: 10.3748/wjg.v10.i5.668.

  PMID: 14991935 BACKGROUND

• Gatta L, Vakil N, Leandro G, Di Mario F, Vaira D. Sequential therapy or triple therapy for Helicobacter pylori infection: systematic review and meta-analysis of randomized controlled trials in adults and children. Am J Gastroenterol. 2009 Dec;104(12):3069-79; quiz 1080. doi: 10.1038/ajg.2009.555. Epub 2009 Oct 20.

  PMID: 19844205 BACKGROUND

• Wu DC, Hsu PI, Wu JY, Opekun AR, Kuo CH, Wu IC, Wang SS, Chen A, Hung WC, Graham DY. Sequential and concomitant therapy with four drugs is equally effective for eradication of H pylori infection. Clin Gastroenterol Hepatol. 2010 Jan;8(1):36-41.e1. doi: 10.1016/j.cgh.2009.09.030. Epub 2009 Oct 3.

  PMID: 19804842 BACKGROUND

• Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.

  PMID: 22491499 BACKGROUND

• Hojo M, Miwa H, Nagahara A, Sato N. Pooled analysis on the efficacy of the second-line treatment regimens for Helicobacter pylori infection. Scand J Gastroenterol. 2001 Jul;36(7):690-700. doi: 10.1080/003655201300191941.

  PMID: 11444467 BACKGROUND

• Saad RJ, Schoenfeld P, Kim HM, Chey WD. Levofloxacin-based triple therapy versus bismuth-based quadruple therapy for persistent Helicobacter pylori infection: a meta-analysis. Am J Gastroenterol. 2006 Mar;101(3):488-96. doi: 10.1111/j.1572-0241.2006.00637.x.

  PMID: 16542284 BACKGROUND

• Pontone S, Standoli M, Angelini R, Pontone P. Efficacy of H. pylori eradication with a sequential regimen followed by rescue therapy in clinical practice. Dig Liver Dis. 2010 Aug;42(8):541-3. doi: 10.1016/j.dld.2009.12.007. Epub 2010 Jan 12.

  PMID: 20061196 BACKGROUND

• Gisbert JP, Molina-Infante J, Marin AC, Vinagre G, Barrio J, McNicholl AG. Second-line rescue triple therapy with levofloxacin after failure of non-bismuth quadruple "sequential" or "concomitant" treatment to eradicate H. pylori infection. Scand J Gastroenterol. 2013 Jun;48(6):652-6. doi: 10.3109/00365521.2013.786132. Epub 2013 Apr 5.

  PMID: 23556551 BACKGROUND

• Hsu PI, Lai KH, Tseng HH, Liu YC, Yen MY, Lin CK, Lo GH, Huang RL, Huang JS, Cheng JS, Huang WK, Ger LP, Chen W, Hsu PN. Correlation of serum immunoglobulin G Helicobacter pylori antibody titers with histologic and endoscopic findings in patients with dyspepsia. J Clin Gastroenterol. 1997 Dec;25(4):587-91. doi: 10.1097/00004836-199712000-00007.

  PMID: 9451668 BACKGROUND

• Peng NJ, Lai KH, Liu RS, Lee SC, Tsay DG, Lo CC, Tseng HH, Huang WK, Lo GH, Hsu PI. Endoscopic 13C-urea breath test for the diagnosis of Helicobacter pylori infection. Dig Liver Dis. 2003 Feb;35(2):73-7. doi: 10.1016/s1590-8658(03)00014-8.

  PMID: 12747623 BACKGROUND

• Peng NJ, Lai KH, Liu RS, Lee SC, Tsay DG, Lo CC, Tseng HH, Huang WK, Lo GH, Hsu PI. Clinical significance of oral urease in diagnosis of Helicobacter pylori infection by [13C]urea breath test. Dig Dis Sci. 2001 Aug;46(8):1772-8. doi: 10.1023/a:1010626225949.

  PMID: 11508681 BACKGROUND

• Kita T, Sakaeda T, Aoyama N, Sakai T, Kawahara Y, Kasuga M, Okumura K. Optimal dose of omeprazole for CYP2C19 extensive metabolizers in anti-Helicobacter pylori therapy: pharmacokinetic considerations. Biol Pharm Bull. 2002 Jul;25(7):923-7. doi: 10.1248/bpb.25.923.

  PMID: 12132671 BACKGROUND

MeSH Terms

Interventions

Esomeprazole; Amoxicillin; Levofloxacin; Bismuth; 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; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; 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

  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: November 28, 2016
• First Posted: November 30, 2016
• Study Start: February 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 14, 2019
• Results First Posted: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)