Helicobacter InfectionsPhase 3NCT03491995
A Unique Regimen for Treatment of Helicobacter Pylori Infection
A Phase 3 study testing Quadruple therapy and Classic treatment in people with Helicobacter Infections, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or metronidazole was proposed 30 years ago at the first Maastricht conference to treat helicobacter pylori (H. pylori) infection and since that time, it has become the universal and standard treatment for helicobacter pylori. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Helicobacter Infections
- What is being tested?
- Quadruple therapy and Classic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged older than 21 years Presenting by Dyspepsia Infected by H. pylori (as proved by positive stool antigen test) Agreed to participate in the study and signed the consent
Who cannot join
- Patients who have received treatment with proton pump inhibitors within 2 weeks, NSAID or antibiotics within 4 weeks before study entry Patients who had received H pylori treatment before. Patients presenting by upper gastrointestinal bleeding Pregnant females Patients who have significant gastrointestinal, renal, hepatic, cardiovascular, metabolic, hematological disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-elsalam, lecturer, 00201000040794, Sherif_tropical@yahoo.com
About this study
Official title: A Unique Quadruple Regimen for of Helicobacter Pylori
The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or metronidazole was proposed 30 years ago at the first Maastricht conference to treat helicobacter pylori (H. pylori) infection and since that time, it has become the universal and standard treatment for helicobacter pylori.
However, the efficacy of this triple regimen has been seriously challenged, and they are gradually becoming ineffective
Read the detailed description
Growing rates of treatment failure are observed worldwide and the eradication rate of triple therapy has declined over the past few decades. 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 Infections
- Being tested
- Quadruple therapy, Classic treatment
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadruple therapyDrug
Also called Moxiflox, Downoprazol, Nanazoxid, Doxymycin
Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin
Classic treatmentDrug
Also called Downoprazol, Emox, Klacid
Omeprazole, amoxycillin, clarithromycin
| Study group | Role | What they receive |
|---|---|---|
| Quadruple therapy | Experimental | Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin Receives: Drug: Quadruple therapy |
| Classic treatment | Active comparator | Omeprazole, clarithromycin, amoxicillin Receives: Drug: Classic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with eradicated Helicobacter infection
Number of patients with eradicated infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Apr 2018
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Ayman Yousry, Prof, Principal investigator, Head of Hepatology and infectious diseases dept.-Cairo UniversityWalied El-Hossary, MD, Study director, Hepatology and infectious diseases dept.-Cairo UniversityMohamed Alboraie, MD, Study chair, Internal Medicine dept.-Alazhar UniversitySherief Abd-Elsalam, MD, Study chair, Hepatology and Infectious diseases- Tanta UniversityAsem Elfert, Prof, Study chair, Hepatology and Infectious diseases- Tanta UniversityHussein A Elamin, Prof, Study chair, Internal Medicine-Assuit UniversityMohamed Adel Elbasiony, MD, Study chair, Internal Medicine- Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491995
- Sponsor's protocol ID
- Helicobacter study
- Status last verified
- Apr 2018
- First submitted
- 2 Apr 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Unique Quadruple Regimen for of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT03491995
- Acronym / sponsor ID
- Helicobacter study
- Conditions
- Helicobacter Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or metronidazole was proposed 30 years ago at the first Maastricht conference to treat helicobacter pylori (H. pylori) infection and since that time, it has become the universal and standard treatment for helicobacter pylori.
However, the efficacy of this triple regimen has been seriously challenged, and they are gradually becoming ineffective
Detailed description
Growing rates of treatment failure are observed worldwide and the eradication rate of triple therapy has declined over the past few decades. 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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadruple therapy | Experimental | Drug: Quadruple therapyMoxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin |
| Classic treatment | Active comparator | Drug: Classic treatmentOmeprazole, clarithromycin, amoxicillin |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged older than 21 years Presenting by Dyspepsia Infected by H. pylori (as proved by positive stool antigen test) Agreed to participate in the study and signed the consent
Key exclusion criteria (1 listed)
- Patients who have received treatment with proton pump inhibitors within 2 weeks, NSAID or antibiotics within 4 weeks before study entry Patients who had received H pylori treatment before. Patients presenting by upper gastrointestinal bleeding Pregnant females Patients who have significant gastrointestinal, renal, hepatic, cardiovascular, metabolic, hematological disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadruple therapyAlso: Moxiflox, Downoprazol, Nanazoxid, DoxymycinMoxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin | Drug | Quadruple therapy |
| Classic treatmentAlso: Downoprazol, Emox, KlacidOmeprazole, amoxycillin, clarithromycin | Drug | Classic treatment |
Primary outcome
Number of patients with eradicated Helicobacter infection
Time frame: 6 months
Number of patients with eradicated infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Yousry, Prof principal investigator
Head of Hepatology and infectious diseases dept.-Cairo University
Walied El-Hossary, MD study director
Hepatology and infectious diseases dept.-Cairo University
Mohamed Alboraie, MD study chair
Internal Medicine dept.-Alazhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quadruple therapy and Classic treatment in people with Helicobacter Infections, run by Sherief Abd-Elsalam at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, MD (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with eradicated Helicobacter infection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.