Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication

NCT02596620 | Completed Results DMC

• 1 other identifier: CMRPG8C0201
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief Summary

Asia Pacific Consensus states that levofloxacin-based triple therapy as an alternative second-line therapy after Helicobacter pylori (H. pylori) eradication failure when bismuth salts are not available. The investigators compare the efficacies of 10-day levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for patients after failure of standard triple therapy and to determine what clinical and bacterial factors influencing the efficacy of salvage regimens.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Proton pump inhibitor; Eradication

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Successful Eradication of H. Pylori

  Successful eradication of H. pylori is defined as (1) negative results of both rapid urease test and histology, or (2) a negative result of urea breath test at 4 weeks.

  Negative results of H.pylori 4 weeks after eradication

Study Arms (2)

Sequential therapy

EXPERIMENTAL

Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days

Drug: Nexium; Drug: Amolin; Drug: Cravit; Drug: Flagyl

Triple therapy

ACTIVE COMPARATOR

Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days

Drug: Nexium; Drug: Amolin; Drug: Cravit

Interventions

Nexium DRUG

Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms

Also known as: Esomeprazole

Sequential therapy; Triple therapy

Amolin DRUG

Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm

Also known as: Amoxicillin

Sequential therapy; Triple therapy

Cravit DRUG

Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm

Also known as: Levofloxacin

Sequential therapy; Triple therapy

Flagyl DRUG

Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm

Also known as: Metronidazole

Sequential therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive H. pylori-infected participants, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis who failed first-line eradication therapies with standard triple regimens (PPI twice daily, 500 mg of clarithromycin twice daily and 1 g of amoxicillin twice daily)

You may not qualify if:

• Ingestion of antibiotics, bismuth, or proton-pump inhibitors within the prior 4 weeks
• Use of non-steroidal anti-inflammatory drugs within the prior 4 weeks
• Participants with allergic history to the medications used
• Participants with previous gastric surgery
• The coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
• Pregnant women.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (9)

• Chuah SK, Tsay FW, Hsu PI, Wu DC. A new look at anti-Helicobacter pylori therapy. World J Gastroenterol. 2011 Sep 21;17(35):3971-5. doi: 10.3748/wjg.v17.i35.3971.

  PMID: 22046084 RESULT

• Tanaka M, Isogai E, Isogai H, Hayashi S, Hirose K, Kimura K, Sugiyama T, Sato K. Synergic effect of quinolone antibacterial agents and proton pump inhibitors on Helicobacter pylori. J Antimicrob Chemother. 2002 Jun;49(6):1039-40. doi: 10.1093/jac/dkf055. No abstract available.

  PMID: 12039901 RESULT

• Chuah SK, Tai WC, Lee CH, Liang CM, Hu TH. Quinolone-containing therapies in the eradication of Helicobacter pylori. Biomed Res Int. 2014;2014:151543. doi: 10.1155/2014/151543. Epub 2014 Aug 28.

  PMID: 25243116 RESULT

• Vakil N, Megraud F. Eradication therapy for Helicobacter pylori. Gastroenterology. 2007 Sep;133(3):985-1001. doi: 10.1053/j.gastro.2007.07.008.

  PMID: 17854602 RESULT

• 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 RESULT

• 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 RESULT

• Graham DY, Shiotani A. New concepts of resistance in the treatment of Helicobacter pylori infections. Nat Clin Pract Gastroenterol Hepatol. 2008 Jun;5(6):321-31. doi: 10.1038/ncpgasthep1138. Epub 2008 Apr 29.

  PMID: 18446147 RESULT

• Wu IT, Chuah SK, Lee CH, Liang CM, Lu LS, Kuo YH, Yen YH, Hu ML, Chou YP, Yang SC, Kuo CM, Kuo CH, Chien CC, Chiang YS, Chiou SS, Hu TH, Tai WC. Five-year sequential changes in secondary antibiotic resistance of Helicobacter pylori in Taiwan. World J Gastroenterol. 2015 Oct 7;21(37):10669-74. doi: 10.3748/wjg.v21.i37.10669.

  PMID: 26457027 RESULT

• Chuah SK, Liang CM, Lee CH, Chiou SS, Chiu YC, Hu ML, Wu KL, Lu LS, Chou YP, Chang KC, Kuo CH, Kuo CM, Hu TH, Tai WC. A Randomized Control Trial Comparing 2 Levofloxacin-Containing Second-Line Therapies for Helicobacter pylori Eradication. Medicine (Baltimore). 2016 May;95(19):e3586. doi: 10.1097/MD.0000000000003586.

  PMID: 27175657 DERIVED

MeSH Terms

Interventions

Esomeprazole; Amoxicillin; Levofloxacin; Metronidazole

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; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Results Point of Contact

• Title: Dr. Wei-Chen Tai
• Organization: Chang Gung Memorial Hospital, Taiwan

luketai1019@gmail.com

886-975056026

Study Officials

• Wei-Chen Tai, M.D.

  Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 4, 2015
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 28, 2017
• Results First Posted: November 4, 2016

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share