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临床试验/NCT02422706
NCT02422706Unknown3 期

Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori

Sherief Abd-Elsalam1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
120
试验地点
1
主要终点
Number of patients with proven eradication of helicobacter

研究概览

简要总结

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 .

详细描述

Helicobacter pylori (H.pylori) 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 regimens.Omeprazole,Amoxicillin &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 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) 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.

Nitazoxanide (NTZ) is an antibiotic with microbiological characteristics similar to those of Metronidazole which was sittled as a therapy for intestinal protozoa and helminthic infection,and 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 cost.Moreover ;Levofloxacin,PPI,NTZ&Doxycycline (LOAD) regimen with very good results in H.pylori infection ~90% cure rate..But uptil now there are no actual similar reported trials in Egypt.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

blinding was applied by using consecutively numbered envelopes that contained the treatment assignments

入排标准

性别
All
接受健康志愿者

入选标准

  • Consecutive patients with dyspeptic symptoms undergoing upper Gasto-intestinal tract (GIT) endoscopy selecting HP infected patients to be recruited for the study.
  • Patients must have had Helicobacter Pylori - induced disease confirmed by endoscopy and HP monoclonal stool antigen.

排除标准

  • Previous gastric or duedenal operations or malignancy.
  • Active GIT bleeding.
  • Previous treatment for HP.
  • Current use of Antiacids ( proton pump inhibitor ( PPI ), H2 receptor antagonist) , anticoagulant, or recent use of antibiotics (within 6 weeks).
  • Allergy to any medication included in the study.

研究组 & 干预措施

group I

Active Comparator

Metronidazole(MTZ) 500mg twice daily ,Omeprazole 20 mg twice daily as (Proton Pump Inhibitor (PPI)& Clarithromycin 500 mg twice daily .for 14 days .

40 patients

干预措施: Metronidazole(MTZ) (Drug)

group I

Active Comparator

Metronidazole(MTZ) 500mg twice daily ,Omeprazole 20 mg twice daily as (Proton Pump Inhibitor (PPI)& Clarithromycin 500 mg twice daily .for 14 days .

40 patients

干预措施: Omeprazole (Drug)

group I

Active Comparator

Metronidazole(MTZ) 500mg twice daily ,Omeprazole 20 mg twice daily as (Proton Pump Inhibitor (PPI)& Clarithromycin 500 mg twice daily .for 14 days .

40 patients

干预措施: Clarithromycin (Drug)

Group II

Experimental

Nitazoxanide(NTZ)500 mg twice daily ,PPI 20 mg twice daily & Clarithromycin 500 mg twice daily for 14 days.

40 patients.

干预措施: Nitazoxanide (Drug)

Group II

Experimental

Nitazoxanide(NTZ)500 mg twice daily ,PPI 20 mg twice daily & Clarithromycin 500 mg twice daily for 14 days.

40 patients.

干预措施: Clarithromycin (Drug)

Group III

Experimental

Levofloxacin 250 mg once daily,Omeprazole 40mg once daily(PPI),Nitazoxanide (NTZ) 500mg twice daily & Doxicycline 100 mg once daily (LOND).

40 patients

干预措施: Nitazoxanide (Drug)

Group III

Experimental

Levofloxacin 250 mg once daily,Omeprazole 40mg once daily(PPI),Nitazoxanide (NTZ) 500mg twice daily & Doxicycline 100 mg once daily (LOND).

40 patients

干预措施: Omeprazole (Drug)

Group III

Experimental

Levofloxacin 250 mg once daily,Omeprazole 40mg once daily(PPI),Nitazoxanide (NTZ) 500mg twice daily & Doxicycline 100 mg once daily (LOND).

40 patients

干预措施: Levofloxacin (Drug)

Group III

Experimental

Levofloxacin 250 mg once daily,Omeprazole 40mg once daily(PPI),Nitazoxanide (NTZ) 500mg twice daily & Doxicycline 100 mg once daily (LOND).

40 patients

干预措施: Doxicycline (Drug)

结局指标

主要结局

Number of patients with proven eradication of helicobacter

时间窗: 6 weeks

Number of patients with proven eradication of helicobacter after 6 weeks

次要结局

未报告次要终点

研究者

发起方
Sherief Abd-Elsalam
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sherief Abd-Elsalam

Tanta university

Tanta University

研究点 (1)

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