Clinical trial NCT01537055: Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy
Official title: Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection- A Multi-center Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Eradication Rate for Helicobacter
Keywords: H pylori eradication
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: E-DA Hospital
First posted: 2012-02-22
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple therapy in the second line therapy for those who fail from one eradication therapy

Detailed description: About 600 patients who failed from first line triple therapy or sequential therapy will be eligible in this multicenter randomized comparative trial. Eligible patients will be randomized to receive either (1) levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕or (2) levofloxacin-based triple therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)〕. Eradication will be confirmed with 13C-Urea Breath Test 6 weeks after therapy.

Eligibility criteria: Inclusion Criteria:

* H. pylori infected patients who failed from first line therapy will be eligible in this study

Exclusion Criteria:

* Patients were excluded from the study if any one of the following criteria was present:
* children and teenagers aged less than 20 years,
* history of gastrectomy,
* gastric malignancy, including adenocarcinoma and lymphoma,
* previous allergic reaction to antibiotics (amoxicillin, metronidazole, levofloxacin) and PPI (lansoprazole),
* contraindication to treatment drugs,
* pregnant or lactating women, or
* severe concurrent disease

Primary outcomes:
measure: Eradication rate in the second line therapy
timeFrame: 6 weeks
Secondary outcomes:
measure: Incidence of adverse effect
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital, Hsinchu Branch
city: Kaohsiung
country: Taiwan
facility: E-DA Hospital and I-Shou University
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
city: Lienchiang
country: Taiwan
facility: Health Bureau of Lienchiang County
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital
city: Taitung Branch
country: Taiwan
facility: Mackay Memorial Hospital
city: Yunlin
country: Taiwan
facility: National Taiwan University Hospital , Yunlin
Study officials:
affiliation: National Taiwan University Hospital
name: Jyh-Ming Liou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liou JM, Chen CC, Chen MJ, Chang CY, Fang YJ, Lee JY, Sheng WH, Wang HP, Wu MS, Lin JT. Empirical modified sequential therapy containing levofloxacin and high-dose esomeprazole in second-line therapy for Helicobacter pylori infection: a multicentre clinical trial. J Antimicrob Chemother. 2011 Aug;66(8):1847-52. doi: 10.1093/jac/dkr217. Epub 2011 May 31.
citation: Liou JM, Bair MJ, Chen CC, Lee YC, Chen MJ, Chen CC, Tseng CH, Fang YJ, Lee JY, Yang TH, Luo JC, Wu JY, Chang WH, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hung HW, Lin JT, Chang CY, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Levofloxacin Sequential Therapy vs Levofloxacin Triple Therapy in the Second-Line Treatment of Helicobacter pylori: A Randomized Trial. Am J Gastroenterol. 2016 Mar;111(3):381-7. doi: 10.1038/ajg.2015.439. Epub 2016 Feb 2.