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

NCT02422706 | Unknown Phase 3 DMC

• 1 other identifier: HELICOBACTER NEW TREATMENT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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 .

Conditions

Helicobacter-associated Gastritis

Outcome Measures

Primary Outcomes (1)

• Number of patients with proven eradication of helicobacter

  Number of patients with proven eradication of helicobacter after 6 weeks

  6 weeks

Study Arms (3)

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

Drug: Metronidazole(MTZ); Drug: Omeprazole; Drug: Clarithromycin

Group II

EXPERIMENTAL

Nitazoxanide(NTZ)500 mg twice daily ,PPI 20 mg twice daily \& Clarithromycin 500 mg twice daily for 14 days. 40 patients.

Drug: Nitazoxanide; Drug: Clarithromycin

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

Drug: Nitazoxanide; Drug: Omeprazole; Drug: Levofloxacin; Drug: Doxicycline

Interventions

Nitazoxanide DRUG

Nitazoxanide based treatment regimens as a new treatment regimens for helicobacter pylori infection

Also known as: Alenia,parazoxanide,Nitclean

Group II; Group III

Metronidazole(MTZ) DRUG

Metronidazole 500 mg twice daily

Also known as: Flagyl

group I

Omeprazole DRUG

Omeprazole 20 twice daily

Also known as: Omepak. Napizole

Group III; group I

Clarithromycin DRUG

KLacid twice daily

Also known as: KLacid

Group II; group I

Levofloxacin DRUG

Tavanic. Tavacin

Also known as: Levofloxacin once daily

Group III

Doxicycline DRUG

Vibramycin 100 mg twice daily

Also known as: vibramycin. Doxymycin

Group III

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous gastric or duedenal operations or malignancy.
• Active GIT bleeding.
• Pregnancy.
• 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.

Sponsors & Collaborators

• Sherief Abd-Elsalam: lead
• Tanta University: collaborator

Study Sites (1)

Tanta university hospital

Cairo, Egypt

RECRUITING

Related Publications (1)

• Shehata MA, Talaat R, Soliman S, Elmesseri H, Soliman S, Abd-Elsalam S. Randomized controlled study of a novel triple nitazoxanide (NTZ)-containing therapeutic regimen versus the traditional regimen for eradication of Helicobacter pylori infection. Helicobacter. 2017 Oct;22(5). doi: 10.1111/hel.12395. Epub 2017 May 19.

  PMID: 28524341 DERIVED

MeSH Terms

Interventions

nitazoxanide; Metronidazole; Omeprazole; Clarithromycin; Levofloxacin

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Mona AH Shehata, Prof

  liver dis dept

  STUDY CHAIR

• Sherief Abd-Elsalam, Consultant

  Division of Gastroenterology and Hepatology- Tanta

  STUDY DIRECTOR

• Raghda Talaat, Prof

  Microbiology

  STUDY CHAIR

• Huda Elmesseri, Specialist

  liver diseases dept.-Elmahalla hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: blinding was applied by using consecutively numbered envelopes that contained the treatment assignments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Tanta university

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 21, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

EG (1)