Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection

Zahra Vahdat Shariatpanahi

Status and phase: Completed; Phase 4

Conditions: Helicobacter Infection

Treatments: Drug: Klacid; Drug: Nexium; Drug: Tavanex; Drug: Lanzol; Drug: Iramox; Drug: Tinafas

Study type: Interventional

Funder types: Other

Identifiers

NCT02711176

22/52/1662

Details and patient eligibility

About

This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.

Full description

Multiple regimens have been evaluated for H. pylori therapy in randomized controlled trials The treatment regimen that is selected must be effective, but considerations such as cost, side effects, and ease of administration should also be taken into account. Despite the number of studies, the optimal therapeutic regimen has not yet been defined.

The regimen most commonly recommended for first line treatment of H. pylori is triple therapy with a PPI, amoxicillin and clarithromycin for 14 days. However, the multi-drug application is associated with remarkable side effects and it is not uncommon not to be able to complete a treatment course. Thus, treatment failure is associated with H. pylori strains that are resistant to the commonly used antibiotics. This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients who proved H. pylori infection following three methods

  • Positive rapid urease test
  • Histologic evidence of H. pylori by modified Giemsa staining
  • Positive stool Antigen Test

Exclusion criteria

• Patients who received eradication therapy for H. pylori infection, previously
• H. pylori eradication failure because of poor compliance
• The administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
• Advanced gastric cancer or other malignancy
• Abnormal liver function or liver cirrhosis
• Abnormal renal function or chronic kidney disease
• Other severe concurrent diseases
• Previous allergic reactions to the study drugs
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

Tavanex & Nexium & Tinafas

Experimental group

Description:

Patients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days"

Treatment:

Drug: Tinafas

Drug: Tavanex

Drug: Nexium

Lanzol & Klacid &Iramox

Active Comparator group

Description:

Patients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days

Treatment:

Drug: Iramox

Drug: Lanzol

Drug: Klacid