A Two Week Nitazoxanidebased Quadruple Regimen

Tanta University

Status and phase: Unknown; Phase 3

Conditions: Dyspepsia

Treatments: Drug: Levofloxacin; Drug: Doxycyclin; Drug: Omeprazole; Drug: Nitazoxanide

Study type: Interventional

Funder types: Other

Identifiers

NCT02621359

Quadruple therapy

Details and patient eligibility

About

Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.

Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications .

However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries.

Treatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .

Full description

Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research.

Unfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth [11]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with helicobacter infection.
• in whom the standard triple therapy (clarithromycin-based triple therapy) failed

Exclusion criteria

• Patients under 18 or over 65 years of age.
• Those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies
• pregnancy/lactation
• having contraindication or allergy to any of the study drugs

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Quadruple therapy

Experimental group

Description:

Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.

Treatment:

Drug: Nitazoxanide

Drug: Omeprazole

Drug: Doxycyclin

Drug: Levofloxacin