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Comparison Between Quadruple Regimens for Helicobacter Pylori Infection in Egypt

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ClinicalTrials.gov Identifier: NCT04039412
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman Magd Eldin Mohammad Sadek, Zagazig University

Brief Summary:
The overall prevalence of H. Pylori in the developing countries is 50.8%, with the highest one presented in Africa (79.1%). Hybrid therapy is supposed to be more effective as a first-line regimen for Helicobacter pylori infection in Egypt than the Reverse hybrid and non-bismuth Levofloxacin quadruple therapies. We are aiming here to compare the Hybrid, Reverse hybrid, and Levofloxacin quadruple therapies as first-line therapy, trying to reach the safest, cost-effective, and compliance-inducing regimen in Egypt. We will conduct a randomized controlled (interventional) study at Zagazig University Hospital, internal medicine department clinic, on 330 patients. 110 patients will be allocated to each regimen.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Hybrid regimen Drug: Reverse hybrid regimen Drug: Levofloxacin quadruple regimen Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized controlled (interventional) study conducted at Zagazig University Hospital, internal medicine department clinic
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Hybrid, Reverse Hybrid, and Non-Bismuth Levofloxacin Quadruple Regimens for Helicobacter Pylori Infection in Egypt: A Randomized Controlled Trial
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : December 22, 2018
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: (1) Hybrid regimen
omeprazole 20mg bid, and amoxicillin 1gm bid in the 1st week, then clarithromycin 500mg bid, omeprazole 20mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid in the 2nd week.
Drug: Hybrid regimen
two-step (dual-quadruple) treatment

Active Comparator: (2) Reverse hybrid regimen
clarithromycin 500mg bid, omeprazole 20mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid for 1 week, followed by omeprazole 20mg bid, and amoxicillin 1gm bid in the 2nd week.
Drug: Reverse hybrid regimen
one-step two-phase (quadruple-dual) treatment

Active Comparator: (3) Levofloxacin quadruple regimen
levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days. (LOAD)
Drug: Levofloxacin quadruple regimen
non-Clarithromycin non-Bismuth quadruple therapy




Primary Outcome Measures :
  1. Percentage of Helicobacter Pylori Infection cure [ Time Frame: 40-44 days ]
    fecal antigen test

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 10-14 days ]
    questionnaire


Secondary Outcome Measures :
  1. Rate of Helicobacter Pylori treatment completion [ Time Frame: 10-14 days ]
    questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive Helicobacter pylori antigen in the stool
  • Treatment-naive

Exclusion Criteria:

  • Previous treatment for Helicobacter pylori
  • Drug hypersensitivity

Information from the National Library of Medicine

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): NCT04039412


Locations
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Egypt
Faculty of Human Medicine, Zagazig University
Zagazig, Sharkia, Egypt, 44519
Sponsors and Collaborators
Ayman Magd Eldin Mohammad Sadek
Investigators
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Study Director: Ayman MM Sadek, MD Zagazig University
  Study Documents (Full-Text)

Documents provided by Ayman Magd Eldin Mohammad Sadek, Zagazig University:

Publications:
El Dine SS, Mubarak M, Salama R, El Raziky M, El Sherbiny E, Zakaria S, Zakaria MS. Low Seroprevalence of anti-CagA antibodies inspite of high seroprevalence of anti-H. Pylori antibodies in rural Egyptian community. Research Journal of Medicine and Medical Sciences. 2008; 3(2):118-23.
Diab M, El-Dine SS, Aboul-Fadl L, Shemis M, Omran Z, Badawi A, El-Ghannam M, El-Ray A, Fam N, El-Defrawy I, El-Sherbini E. Helicobacterpylori cag pathogenicity island genes among dyspeptic patients with chronic gastritis. Egypt J Med Microbiol. 2009; 18:43-53.

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Responsible Party: Ayman Magd Eldin Mohammad Sadek, Clinical Professor, Zagazig University
ClinicalTrials.gov Identifier: NCT04039412     History of Changes
Other Study ID Numbers: ZU-IRB#5089
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After study publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ayman Magd Eldin Mohammad Sadek, Zagazig University:
Helicobacter Pylori Infection
Quadruple Therapy
Egypt

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Levofloxacin
Ofloxacin
Anti-Infective Agents
Anti-Bacterial Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors