A Two Week Nitazoxanidebased Quadruple Regimen

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02621359

Collaborator

(none)

100

Enrollment

Location

Arm

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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

pylori in approximately 20% of cases .

Condition or Disease	Intervention/Treatment	Phase
Dyspepsia	Drug: Nitazoxanide Drug: Levofloxacin Drug: Doxycyclin Drug: Omeprazole	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Two Week Nitazoxanidebased Quadruple Regimen for Helicobacter Pylori Therapy After Failure of Standard Triple Therapy: A Single Center Experience

Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quadruple therapy Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.	Drug: Nitazoxanide Nitazoxanide 500 mg twice daily Other Names: Alenia, nitclean, parazoxanide Drug: Levofloxacin Levofloxacin 500 mg once daily Other Names: Tavanic, levoxin, venaxan. Drug: Doxycyclin Doxycyclin 100 mg twice daily Other Names: Vibramycin, Doxymycin Drug: Omeprazole Omeprazole 40 mg twice daily Other Names: Omepak, Pepzole, Gasec, Risek.

Arm

Intervention/Treatment

Experimental: Quadruple therapy

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

Drug: Nitazoxanide

Nitazoxanide 500 mg twice daily

Other Names:

Alenia, nitclean, parazoxanide

Drug: Levofloxacin

Levofloxacin 500 mg once daily

Other Names:

Tavanic, levoxin, venaxan.

Drug: Doxycyclin

Doxycyclin 100 mg twice daily

Other Names:

Vibramycin, Doxymycin

Drug: Omeprazole

Omeprazole 40 mg twice daily

Other Names:

Omepak, Pepzole, Gasec, Risek.

Outcome Measures

Primary Outcome Measures

Number of patients with eradicated helicobacter [1 year]
The total number of patients with eradicated helicobacter

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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