Ignite Creation Date:
2024-05-06 @ 3:59 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02422706
Status:
UNKNOWN
Last Update Posted:
2017-04-25
First Post:
2015-04-13
Brief Title:
Study of Nitazoxanide NTZ Based New Therapeutic Regimens for Helicobacter Pylori
Sponsor:
Sherief Abd-Elsalam
Organization:
Tanta University
Study Overview
Official Title:
Study of Nitazoxanide NTZ Based New Therapeutic Regimens for Helicobacter Pylori
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Hpylori 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
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
Detailed Description:
Helicobacter pylori Hpylori is a small Gram-negative spirochete inhabiting the mucous layer overlying the gastric epithelial cells in humans It is the most common prevalent chronic human bacterial infection and the most common cause of gastritis worldwide Furthermore according to the World Health Organization HP is classified as a type 1 carcinogen and is the primary cause of peptic ulcer disease gastric carcinoma and mucosa-associated lymphoid tissue lymphomas
Current Helicobacter Pylori infection preferred treatment involves proton pump inhibitor PPI-based triple or qudrable regimensOmeprazoleAmoxicillin Clarithromycin is one of a global standard care for confirmed Hpylori infection Metronidazole MTZ is used instead of Amoxicillin or Clarithromycin in cases of allergy or resistance
However a study by Rokkas et al 2008 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 basisand will fail in 50 of patients who treated with PPI-based triple regimen with MetronidazoleThis 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
Nitazoxanide NTZ is an antibiotic with microbiological characteristics similar to those of Metronidazole which was sittled as a therapy for intestinal protozoa and helminthic infectionand was studied as an additional therapy with Peg Interferon and Ribavirin for chronic hepatitis C virus HCV
In the last few years Nitazoxanide was evaluated as a single agent therapy for H Pylori infection showing controversed results However NTZ based regimens were recently studied showing interesting results without the apparent problem of resistance as Metronidazole with nearby costMoreover LevofloxacinPPINTZDoxycycline LOAD regimen with very good results in Hpylori infection 90 cure rateBut uptil now there are no actual similar reported trials in Egypt
Current Helicobacter Pylori infection preferred treatment involves proton pump inhibitor PPI-based triple or qudrable regimensOmeprazoleAmoxicillin Clarithromycin is one of a global standard care for confirmed Hpylori infection Metronidazole MTZ is used instead of Amoxicillin or Clarithromycin in cases of allergy or resistance
However a study by Rokkas et al 2008 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 basisand will fail in 50 of patients who treated with PPI-based triple regimen with MetronidazoleThis 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
Nitazoxanide NTZ is an antibiotic with microbiological characteristics similar to those of Metronidazole which was sittled as a therapy for intestinal protozoa and helminthic infectionand was studied as an additional therapy with Peg Interferon and Ribavirin for chronic hepatitis C virus HCV
In the last few years Nitazoxanide was evaluated as a single agent therapy for H Pylori infection showing controversed results However NTZ based regimens were recently studied showing interesting results without the apparent problem of resistance as Metronidazole with nearby costMoreover LevofloxacinPPINTZDoxycycline LOAD regimen with very good results in Hpylori infection 90 cure rateBut uptil now there are no actual similar reported trials in Egypt
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None