Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication

Helicobacter Pylori Infection Clinical Trial

Official title:

The Efficacy of 10-day Metronidazole and Levofloxacin Containing Sequential Therapy and 10-day Levofloxacin-containing Triple Therapy In Second Line Helicobacter Pylori Eradication Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596620
• Other study ID #: CMRPG8C0201
• Status: Completed
• Phase: N/A
• First received: November 2, 2015
• Last updated: November 4, 2015
• Start date: October 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

In this randomized-controlled trial , the investigator recruited participants with H pylori infection after failure of first line standard triple therapy. Using a computer-generated randomization sequence, the investigators randomly allocated patients to either 10-day levofloxacin-containing sequential (EALM, esomeprazole 40 mg b.d., amoxicillin 1 g b.d.for 5 days and followed by esomeprazole 40 mg b.d., levofloxacin 500 mg qd and metronidazole for 5 days) or 10-day levofloxacin-containing triple therapy (EAL, esomeprazole 40 mg b.d., amoxicillin 1 g b.d., and levofloxacin 500 mg qd) at a 1:1 ratio. The primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• Nexium
Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms
• Amolin
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
• Cravit
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
• Flagyl
Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

References & Publications (8)

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. Review. — View Citation

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. Review. — View Citation

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 infectio — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Vakil N, Megraud F. Eradication therapy for Helicobacter pylori. Gastroenterology. 2007 Sep;133(3):985-1001. Review. — View Citation

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 Gast — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 4-8 weeks.	Negative results of H.pylori 4-8 weeks after eradication	Yes
Secondary	Adverse events during therapies	Adverse events were evaluated such as abdominal pain, diarrhea, constipation, dizziness, taste perversion, headache, anorexia, nausea, vomiting and skin rash that bother patients' daily life quality.	At day 11 as soon as the participants finished all drugs (10 day treatment duration)	Yes