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Efficacy of Levofloxacin- containing versus Clarithromycin -containing Sequential Therapies in Helicobacter pylori Eradication

Comparison of Levofloxacin- containing and Clarithromycin -containing Sequential Therapies for Helicobacter pylori Eradication in Iran: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015030820178N2
Enrollment
182
Registered
2015-03-26
Start date
2015-01-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric ulcer or erosion-deudenal ulcer or erosion. Gastric ulcer-Duodenal ulcer- Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters

Interventions

Intervention 1: Group A:10 days of sequential therapy (esomeprazole 40 mg twice daily, amoxicillin 1g twice daily for 5 days followed by esomeprazole 40 mg twice daily, levofloxacin 500 mg twice daily
Treatment - Drugs
Group A:10 days of sequential therapy (esomeprazole 40 mg twice daily, amoxicillin 1g twice daily for 5 days followed by esomeprazole 40 mg twice daily, levofloxacin 500 mg twice daily, and tinidazol
Group B:10 days of sequential therapy (esomeprazole 40 mg twice daily, amoxicillin 1g twice daily for 5 days followed by esomeprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and tinidaz

Sponsors

Iran University of Medical Sciences,Rasoul Akram Hospital,Colorectal Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria:age more than18 years,patients with endoscopically confirmed peptic ulcer or gastric/duodenal erosions and H. pylori infection documentation by antral biopsy (Giemsa staining) and/or rapid urease test (RUT). exclusion criteria:pregnancy, breast-feeding, previous history of helicobacter pylori eradication,significant underlying diseases such as liver, cardiac, pulmonary or renal diseases, neoplasms, coagulopathy, history of gastric surgery, taking antibiotics,proton pump inhibior and /or histamin2 receptor antagonist during the previous2 weeks,concomitant use ofanticoagulant and/or corticosteroid, and previous history of allergic reaction to any medications used in this study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate. Timepoint: Ten weeks after starting treatment. Method of measurement: urea breath test(UBT).

Secondary

MeasureTime frame
Drug adverse effect rate. Timepoint: Two weeks after starting treatment. Method of measurement: Data gathering sheet.;Patient compliance rate. Timepoint: Two weeks after starting treatment. Method of measurement: Remained pill count.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Nikkhah

Rasaul Akram Hospital

nikkhahmd@yahoo.com+98 21 6655 4790

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026