A Phase 4 interventional study of Hybrid regimen and Reverse hybrid regimen in Helicobacter Pylori Infection, sponsored by Ayman Magd Eldin Mohammad Sadek. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-26.
Sponsored by Ayman Magd Eldin Mohammad Sadek · Phase 4, Interventional, and Treatment
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.
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:
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:
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 330 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Ayman Magd Eldin Mohammad Sadek is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days. (LOAD)
Drug: Levofloxacin quadruple regimen
two-step (dual-quadruple) treatment
one-step two-phase (quadruple-dual) treatment
non-Clarithromycin non-Bismuth quadruple therapy
Percentage of Helicobacter Pylori Infection Cure
Measuring the curative rate of each regimen by a fecal antigen test
Time frame: 40-44 days
Incidence of Treatment-Emergent Adverse Events
Questionnaire to measure the number of Participants with Treatment-Emergent Adverse Events
Time frame: 10-14 days
Rate of Helicobacter Pylori Treatment Completion
Questionnaire to evaluate the compliance with each treatment regimen
Time frame: 10-14 days
We conducted an interventional randomized trial at the internal medicine department clinic, Zagazig University Hospital, Zagazig, Egypt, in the period from July 2018 to June 2019. We allocated the participants attending the clinic by simple randomization over the three treatment groups.
| Milestone | (1) Reverse Hybrid Regimen | (2) Hybrid Regimen | (3) Levofloxacin Quadruple Regimen |
|---|---|---|---|
| Started | 110 | 110 | 110 |
| Completed | 109 | 107 | 108 |
| Not completed | 1 | 3 | 2 |
Measuring the curative rate of each regimen by a fecal antigen test
| Participants | (1) Reverse Hybrid Regimen | (2) Hybrid Regimen | (3) Levofloxacin Quadruple Regimen |
|---|---|---|---|
| Percentage of Helicobacter Pylori Infection Cure | 102 | 101 | 91 |
Questionnaire to measure the number of Participants with Treatment-Emergent Adverse Events
| Participants | (1) Reverse Hybrid Regimen | (2) Hybrid Regimen | (3) Levofloxacin Quadruple Regimen |
|---|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 49 | 58 | 44 |
Questionnaire to evaluate the compliance with each treatment regimen
| Participants | (1) Reverse Hybrid Regimen | (2) Hybrid Regimen | (3) Levofloxacin Quadruple Regimen |
|---|---|---|---|
| Rate of Helicobacter Pylori Treatment Completion | 109 | 107 | 108 |
Collected over We followed up the occurrence of adverse events after one week of therapy, at the end of treatment, and Up to 45 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| (1) Reverse Hybrid Regimen | 0/109 (0%) | 0/109 (0%) | 49/110 (44.5%) |
| (2) Hybrid Regimen | 0/107 (0%) | 0/107 (0%) | 58/110 (52.7%) |
| (3) Levofloxacin Quadruple Regimen | 0/108 (0%) | 0/108 (0%) | 44/110 (40%) |
| Event | (1) Reverse Hybrid Regimen | (2) Hybrid Regimen | (3) Levofloxacin Quadruple Regimen |
|---|---|---|---|
| Gastrointestinal symptomsGastrointestinal disorders | 41/110 | 50/110 | 37/110 |
| General symptomsGeneral disorders | 8/110 | 8/110 | 7/110 |
| Age, Continuous(years) | (1) Reverse Hybrid Regimen | (2) Hybrid Regimen | (3) Levofloxacin Quadruple Regimen | Total |
|---|---|---|---|---|
| Mean | 32.05 ± 9.772 | 32.31 ± 9.409 | 32.44 ± 9.713 | 32.27 ± 9.604 |
| Sex: Female, Male(Participants) | (1) Reverse Hybrid Regimen | (2) Hybrid Regimen | (3) Levofloxacin Quadruple Regimen | Total |
|---|---|---|---|---|
| Female | 57 | 58 | 55 | 170 |
| Male | 53 | 52 | 55 | 160 |
| Race and Ethnicity Not Collected(Participants) | (1) Reverse Hybrid Regimen | (2) Hybrid Regimen | (3) Levofloxacin Quadruple Regimen | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | (1) Reverse Hybrid Regimen | (2) Hybrid Regimen | (3) Levofloxacin Quadruple Regimen | Total |
|---|---|---|---|---|
| Egypt | 110 | 110 | 110 | 330 |
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Plan to share: Yes
Supporting information: Study protocol, Sap
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Ayman Magd Eldin Mohammad Sadek