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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
Results First Posted : November 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman Magd Eldin Mohammad Sadek, Zagazig University

Tracking Information
First Submitted Date  ICMJE July 4, 2019
First Posted Date  ICMJE July 31, 2019
Results First Submitted Date  ICMJE September 22, 2019
Results First Posted Date  ICMJE November 26, 2019
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE June 1, 2018
Actual Primary Completion Date December 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2019)
  • Percentage of Helicobacter Pylori Infection Cure [ Time Frame: 40-44 days ]
    Measuring the curative rate of each regimen by a fecal antigen test
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 10-14 days ]
    Questionnaire to measure the number of Participants with Treatment-Emergent Adverse Events
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
  • Percentage of Helicobacter Pylori Infection Cure [ Time Frame: 40-44 days ]
    fecal antigen test
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 10-14 days ]
    questionnaire
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2019)		 Rate of Helicobacter Pylori Treatment Completion [ Time Frame: 10-14 days ]
Questionnaire to evaluate the compliance with each treatment regimen
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2019)		 Rate of Helicobacter Pylori Treatment Completion [ Time Frame: 10-14 days ]
questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Quadruple Regimens for Helicobacter Pylori Infection in Egypt
Official Title  ICMJE Comparison Between Hybrid, Reverse Hybrid, and Non-Bismuth Levofloxacin Quadruple Regimens for Helicobacter Pylori Infection in Egypt: A Randomized Controlled Trial
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.
Detailed Description

Introduction:

Although the decreasing prevalence of Helicobacter Pylori (H. Pylori) worldwide, it remains high in developing countries. According to the most recent studies, the overall prevalence of H. Pylori in the developing countries is 50.8%, with the highest one presented in Africa (79.1%).

Unfortunately, the data on the prevalence of H. Pylori, are not available from all the countries of Africa. There is a paucity of information about the magnitude of the problem in Egypt, according to the few available studies, the prevalence is ranging from 71.7-91.7%.

The importance of H. Pylori infection lies in the major role in chronic gastritis, gastric ulcer, and duodenal ulcer, up to gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue lymphoma.

Diagnosis of H. Pylori can be through invasive tests, which are cumbersome and expensive despite their high sensitivity and specificity. On the contrary, there are more easily and cheaper non-invasive tests, especially H. Pylori stool antigen and urea breath test that has a higher sensitivity than serology.

The decreasing eradication rate of the standard triple therapy (STT) below 80% due to the emergence of resistant strains to Clarithromycin, raise the need for newer therapies that provide higher efficacy, and in the same time, better safety and compliance.

Bismuth-containing quadruple therapy came as the treatment of choice that avoids Clarithromycin use, but it was a non-reasonable option for the countries that are lacking in bismuth salts and/or tetracycline, beside of the complex administration and low safety. It raises the era of the competing sequential and concomitant non-bismuth (clarithromycin containing) quadruple treatments.

A novel two-step (dual-quadruple) treatment called the hybrid therapy (HT), which is actually a combined sequential and concomitant therapy, with a lower cost and better efficacy.

However, the adding of two drugs in the last seven days of the therapy may confuse the patient, making him less willing to complete the treatment that promote the idea of reversing the sequence (quadruple-dual) in what is called the reverse hybrid therapy (RHT), to simplify the treatment in one-step two-phase treatment.

Another non-Clarithromycin non-Bismuth quadruple therapy that is less complex and safer than bismuth quadruple therapy, which is called Levofloxacin quadruple therapy that contains levofloxacin, omeprazole, nitazoxanide, and doxycycline (LOND), showed promising results on the level of the cure rate and low drug resistance profile.

Methods:

Technical Design:

A) The site of study:

The study was conducted in Internal medicine department clinic in Zagazig University Hospitals.

B) Sample size:

Assuming that the eradication rate in patients receiving Hybrid therapy is 91% versus 78.3% in Reverse Hybrid therapy. So, the sample size is 309, using OPEN EPI at power 80% and C.I 95%.

Tools of data collection:

  1. Medical history to all participants.
  2. Complete clinical examination.
  3. The fecal antigen test (FAT) which identifies H. pylori antigen in the stool by enzyme immunoassay was positive in all participants.

Operational design:

A) This is a randomized (interventional) study conducted at Zagazig University Hospital, internal medicine department clinic after informed consent. All the participants were positive for H. pylori fecal antigen test.

B) Steps of performance: (330) participants were chosen from the Internal Medicine Department clinic, grouped into 3 groups:

  1. Group 1: (110) participants received reverse hybrid regimen in the form of clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500 mg tid for 1 week, followed by omeprazole 20 mg bid, and amoxicillin 1gm bid in the 2nd week.
  2. Group2: (110) participants received hybrid regimen in the form of omeprazole 20 mg bid, and amoxicillin 1gm bid in the 1st week, then clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500 mg tid in the 2nd week.
  3. Group3: (110) participants received Levofloxacin quadruple regimen (LOAD) in the form of nitazoxanide 500 mg bid, levofloxacin 250 mg QD, omeprazole 40 mg QD, and doxycycline 100 mg QD for 10 days

C) Retesting by The fecal antigen test (FAT) after stopping the regimen by at least one month and withholding proton pump inhibitors for four weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Helicobacter Pylori Infection
Intervention  ICMJE
  • Drug: Hybrid regimen
    two-step (dual-quadruple) treatment
  • Drug: Reverse hybrid regimen
    one-step two-phase (quadruple-dual) treatment
  • Drug: Levofloxacin quadruple regimen
    non-Clarithromycin non-Bismuth quadruple therapy
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Hybrid regimen
  • 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.
    Intervention: Drug: Reverse hybrid regimen
  • Active Comparator: (3) Levofloxacin quadruple regimen
    levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days. (LOAD)
    Intervention: Drug: Levofloxacin quadruple regimen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2019)		 330
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date December 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous treatment for Helicobacter pylori
  • Drug hypersensitivity
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04039412
Other Study ID Numbers  ICMJE ZU-IRB#5089
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: After study publication
Responsible Party Ayman Magd Eldin Mohammad Sadek, Zagazig University
Study Sponsor  ICMJE Ayman Magd Eldin Mohammad Sadek
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ayman MM Sadek, MD Zagazig University
PRS Account Zagazig University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP