A Two Week Nitazoxanidebased Quadruple Regimen
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|ClinicalTrials.gov Identifier: NCT02621359|
Recruitment Status : Recruiting
First Posted : December 3, 2015
Last Update Posted : January 3, 2018
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 .
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia||Drug: Nitazoxanide Drug: Levofloxacin Drug: Doxycyclin Drug: Omeprazole||Phase 3|
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 . 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||January 2015|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
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.
Nitazoxanide 500 mg twice daily
Other Name: Alenia, nitclean, parazoxanide
Levofloxacin 500 mg once daily
Other Name: Tavanic, levoxin, venaxan.
Doxycyclin 100 mg twice daily
Other Name: Vibramycin, Doxymycin
Omeprazole 40 mg twice daily
Other Name: Omepak, Pepzole, Gasec, Risek.
- Number of patients with eradicated helicobacter [ Time Frame: 1 year ]The total number of patients with eradicated helicobacter
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621359
|Contact: Sherief Abd-Elsalam, firstname.lastname@example.org|
|Tropical medicine dept.-Tanta university hospital||Recruiting|
|Contact: Sherief Abd-Elsalam, lecturer 00201095159522 Sherif_tropical@yahoo.com|
|Principal Investigator:||Sherief Abd-Elsalam, lecturer||Tropical medicine-Tanta university hospital|