Helicobacter Pylori InfectionPhase 4NCT06065267
Levofloxacin Concomitant Versus Levofloxacin Sequential
A Phase 4 study testing sequential and Levofloxacin 500Mg Oral Tablet in people with Helicobacter Pylori Infection, run by Damascus Hospital at 1 site in Syria.
Trial summary
The goal of this trial is to determine the efficacy of levofloxacin based sequential treatment regimen or concomitant levofloxacin based regimens as empirical first-line therapy in the Syrian population Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- sequential and Levofloxacin 500Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSyria
- Study dates
- 2 Jan 2024to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:
- Positive rapid urease test (CLOtest).
- Histologic evidence of H. pylori by modified Giemsa staining.
- Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.
Who cannot join
- Children and teenagers aged less than 18 years.
- Previous eradication treatment for H. pylori.
- Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
- History of gastrectomy.
- Gastric malignancy, including adenocarcinoma and lymphoma,
- Previous allergic reaction to antibiotics (Amoxicillin, Tinadizole,
Show all 11Show fewer
- Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).
- Contraindication to treatment drugs.
- Pregnant or lactating women.
- Severe concurrent disease.
- Liver cirrhosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Syria1 site
General Assembly of Damascus Hospital
Damascus
Marouf MI Alhalabi, MD, +963952781278, e.marouf@hotmail.com
About this study
Official title: Efficacy of Two-week Therapy With Levofloxacin-based Concomitant Regimen Versus Levofloxacin-based Sequential Regimen for Helicobacter Pylori Infection in Syrian Population: a Prospective Single-center Randomized Controlled Trial
The goal of this trial is to determine the efficacy of levofloxacin based sequential treatment regimen or concomitant levofloxacin based regimens as empirical first-line therapy in the Syrian population
- Conditions
- Helicobacter Pylori Infection
- Being tested
- sequential, Levofloxacin 500Mg Oral Tablet
- Keywords
- Helicobacter Pylori, levofloxacine, concomitant, sequential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequentialDrug
Also called Esomeprazole, levofloxacine, metronidazole, amoxicillin
amoxicillin 1000 mg bid ,esomprazole 20 bid for one week then levofloxacine 500 mg q.d, metraonidazoel 500 500 bid, and esomprazole 20 bid for one week
Levofloxacin 500Mg Oral TabletDrug
Also called Amoxicilline, Esomeprazol, Tinadizole
Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid
| Study group | Role | What they receive |
|---|---|---|
| sequential | Experimental | Measure eradication rate of Helicobacter pylori infection with Levofloxacien sequential based regimen Receives: Drug: sequential |
| concomitant | Active comparator | Measure eradication rate of Helicobacter pylori infection with Livofloxacine concomitant based regimen Receives: Drug: Levofloxacin 500Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of Helicobacter pylori infection
Eradication rate of Helicobacter infected patients
Measured: 8 week from begning of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start2 Jan 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damascus Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marouf Alhalabi, Damascus Hospital
- Investigators
- Marouf M Alhalabi, MD, Principal investigator, general assambly of damascus hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065267
- Sponsor's protocol ID
- G-9-23
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alhalabi M, Alshiekh HA, Sheikh Alhara AA, Shehab W. Levofloxacin-based concomitant versus sequential therapy for Helicobacter pylori eradication in treatment-naive Syrian patients: a randomized trial showing no superiority of sequential therapy. Gut Pathog. 2026 Sep 19;18(1):77. doi: 10.1186/s13099-026-00881-x.
PubMed 42773456Alhalabi M, Almokdad R. Efficacy of a 2-week therapy with levofloxacin concomitant versus a levofloxacin sequential regimen for Helicobacter pylori infection in the Syrian population: a study protocol for randomized controlled trial. Trials. 2024 Jan 15;25(1):55. doi: 10.1186/s13063-024-07906-3.
PubMed 38225650
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two-week Therapy With Levofloxacin-based Concomitant Regimen Versus Levofloxacin-based Sequential Regimen for Helicobacter Pylori Infection in Syrian Population: a Prospective Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06065267
- Acronym / sponsor ID
- G-9-23
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter Pylori, levofloxacine, concomitant, sequential
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Damascus HospitalUniversity, hospital or other
- Study start
- 2 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Oct 2023 (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 goal of this trial is to determine the efficacy of levofloxacin based sequential treatment regimen or concomitant levofloxacin based regimens as empirical first-line therapy in the Syrian population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequential | Experimental | Drug: sequentialMeasure eradication rate of Helicobacter pylori infection with Levofloxacien sequential based regimen |
| concomitant | Active comparator | Drug: Levofloxacin 500Mg Oral TabletMeasure eradication rate of Helicobacter pylori infection with Livofloxacine concomitant based regimen |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:
- Positive rapid urease test (CLOtest).
- Histologic evidence of H. pylori by modified Giemsa staining.
- Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.
Key exclusion criteria (11 listed)
- Children and teenagers aged less than 18 years.
- Previous eradication treatment for H. pylori.
- Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
- History of gastrectomy.
- Gastric malignancy, including adenocarcinoma and lymphoma,
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 |
|---|---|---|
| sequentialAlso: Esomeprazole, levofloxacine, metronidazole, amoxicillinamoxicillin 1000 mg bid ,esomprazole 20 bid for one week then levofloxacine 500 mg q.d, metraonidazoel 500 500 bid, and esomprazole 20 bid for one week | Drug | sequential |
| Levofloxacin 500Mg Oral TabletAlso: Amoxicilline, Esomeprazol, TinadizoleLevofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid | Drug | concomitant |
Primary outcome
Eradication rate of Helicobacter pylori infection
Time frame: 8 week from begning of treatment
Eradication rate of Helicobacter infected patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Derived from this study: PubMed 42773456Alhalabi M, Alshiekh HA, Sheikh Alhara AA, Shehab W. Levofloxacin-based concomitant versus sequential therapy for Helicobacter pylori eradication in treatment-naive Syrian patients: a randomized trial showing no superiority of sequential therapy. Gut Pathog. 2026 Sep 19;18(1):77. doi: 10.1186/s13099-026-00881-x.
- Derived from this study: PubMed 38225650Alhalabi M, Almokdad R. Efficacy of a 2-week therapy with levofloxacin concomitant versus a levofloxacin sequential regimen for Helicobacter pylori infection in the Syrian population: a study protocol for randomized controlled trial. Trials. 2024 Jan 15;25(1):55. doi: 10.1186/s13063-024-07906-3.
- 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.
Marouf M Alhalabi, MD principal investigator
general assambly of damascus hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sequential and Levofloxacin 500Mg Oral Tablet in people with Helicobacter Pylori Infection, run by Damascus Hospital at 1 site in Syria.
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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 3 Oct 2023. 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 Syria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marouf MH Alhalabi, MD (+963952781278, e.marouf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate of Helicobacter pylori infection (time frame: 8 week from begning of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06065267, which also lists 2 linked publications.
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 3 Oct 2023.