A Two Week Nitazoxanidebased Quadruple Regimen

Phase 3

• Conditions: Dyspepsia
• Interventions: Drug: Nitazoxanide; Drug: Levofloxacin; Drug: Doxycyclin; Drug: Omeprazole

• Registration Number: NCT02621359
• Lead Sponsor: Tanta University

Brief Summary

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 .

Detailed 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-11-27
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-03
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-30
• Last Update Posted: 2018-01-03
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Quadruple therapy	Omeprazole	Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.
Quadruple therapy	Levofloxacin	Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.
Quadruple therapy	Nitazoxanide	Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.
Quadruple therapy	Doxycyclin	Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.

Primary Outcome Measures

Name	Time	Method
Number of patients with eradicated helicobacter	1 year	The total number of patients with eradicated helicobacter

Trial Locations

Locations (1)

Tropical medicine dept.-Tanta university hospital; 🇪🇬 Tanta, Egypt