Clinical trial NCT02596620: Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Proton pump inhibitor
Eradication
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Successful Eradication of H. Pylori
timeFrame: Negative results of H.pylori 4 weeks after eradication
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Taiwan
name: Wei-Chen Tai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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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 Gastroenterol. 2015 Oct 7;21(37):10669-74. doi: 10.3748/wjg.v21.i37.10669.
citation: 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.