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Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy

Information source: National Taiwan University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Eradication Rate for Helicobacter

Intervention: levofloxacin-based sequential therapy (Drug); levofloxacin-based triple therapy for 10 days (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: National Taiwan University Hospital

Official(s) and/or principal investigator(s):
Jyh-Ming Liou, MD, Principal Investigator, Affiliation: National Taiwan University Hospital

Overall contact:
Jyh-Ming Liou, MD, Phone: 886-972651883, Email: dtmed046@pchome.com.tw

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Eradication rate in the second line therapy

Secondary outcome: Incidence of adverse effect

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

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Jyh-Ming Liou, MD, Phone: 886-972651883, Email: dtmed046@pchome.com.tw

National Taiwan University Hospital, Hsinchu Branch, Hsinchu, Taiwan; Recruiting
Wen-Fong Hsu

E-DA Hospital and I-Shou University, Kaohsiung, Taiwan; Recruiting
Chi-yang Chang

Kaohsiung Medical University, Kaohsiung, Taiwan; Recruiting
Jeng-Yih Wu

Health Bureau of Lienchiang County, Lienchiang, Taiwan; Recruiting
Feng-Yun Tsao

Mackay Memorial Hospital, Taipei, Taiwan; Recruiting
Wen-Hsiung Chang

National Taiwan University Hospital, Taipei 10002, Taiwan; Recruiting
Jyh-Ming Liou, MD, Phone: 886-972651883, Email: dtmed046@pchome.com.tw

Taipei Medical University Hospital, Taipei, Taiwan; Recruiting
Chun-Chao Chang

Taipei Veteran General Hospital, Taipei, Taiwan; Recruiting
Jing-Chuan Luo

Mackay Memorial Hospital, Taitung Branch, Taiwan; Recruiting
Ming-Jong Bair

National Taiwan University Hospital , Yunlin, Yunlin, Taiwan; Recruiting
Chieh-Chang Chen

Additional Information

Related publications:

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.

Starting date: February 2012
Last updated: January 30, 2015

Page last updated: August 23, 2015

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