Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication

Chang Gung Medical Foundation

Status: Completed

Conditions: Helicobacter Pylori Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02596620

CMRPG8C0201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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164 participants in 2 patient groups

Sequential therapy

Experimental group

Description:

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

Treatment:

Drug: Amolin

Drug: Nexium

Drug: Flagyl

Drug: Cravit

Triple therapy

Active Comparator group

Description:

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

Treatment:

Drug: Amolin

Drug: Nexium

Drug: Cravit