Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori
Summary
Current Helicobacter Pylori infection preferred treatment involves; proton pump inhibitor (PPI)-based triple or qudrable regimens. Omeprazole, Amoxicillin, and Clarithromycin is one of a global standard care for confirmed H.pylori infection . Metronidazole (MTZ) is used instead of Amoxicillin or Clarithromycin in cases of allergy or resistance . However, a recent study based on the Maastricht III guidelines, indicated that treatment with a PPI-based triple regimen as first-line therapy will fail in \~30% of patients on an intention-to-treat (ITT) basis, and will fail in \~ 50 % of patients who treated with PPI-based triple regimen with Metronidazole. This treatment resistance is also an issue warranting the investigation of other agents. Helicobacter pylori infection has become increasingly resistant to traditional first-line treatment regimens because of emerging antibiotic resistance coupled with poor patient compliance with completing the treatment course that decrease H. pylori eradication rates. So there is a considerable interest in evaluating new antibiotic combinations and regimens .
Timeline
- Start
- 2015-01
- Primary completion
- 2018-12
- Completion
- 2018-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clarithromycin | Small molecule | 500 mg | — |
| Subject | Doxicycline | Unknown | 100 mg | — |
| Subject | Levofloxacin | Small molecule | 250 mg | — |
| Comparator | Metronidazole | Small molecule | 500 mg | — |
| Subject | Nitazoxanide | Other / unclassified | 500 mg | — |
| Subject | Omeprazole | Other / unclassified | 20 mg | — |
| Subject | Omeprazole | Other / unclassified | 40 mg | — |