Helicobacter Pylori InfectionPhase 4NCT06351891
Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin
A Phase 4 study testing 14-day bismuth quadruple regimen containing cefuroxime and tetracycline and 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin in people with Helicobacter Pylori Infection, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- 14-day bismuth quadruple regimen containing cefuroxime and tetracycline and 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- Apr 2024to Dec 2024
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old, regardless of gender.
- History of penicillin allergy.
- Helicobacter pylori infection.
- Patients who have not previously received Helicobacter pylori eradication therapy.
Who cannot join
- Medication history of bismuth and antibiotics within 4 weeks; PPIs and P-CABs within 2 weeks.
- Serious underlying diseases, such as liver insufficiency, renal insufficiency, malignant tumors, etc.
- Previous gastric or esophageal surgery.
- History of allergy to test drugs.
- Pregnant and lactating women and those unwilling to use contraception during the trial period.
- Have other behaviors that may increase the risk such as alcohol and drug abuse.
- Those unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yueyue Li, MD,PhD, 86-18560089751, lyynqj@162.com
About this study
Official title: Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin: A Multicenter, Randomized Controlled Study
The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- 14-day bismuth quadruple regimen containing cefuroxime and tetracycline, 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin
- Keywords
- Helicobacter Pylori Infection, Bismuth-containing quadruple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14-day bismuth quadruple regimen containing cefuroxime and tetracyclineDrug
14-day bismuth quadruple regimen containing cefuroxime and tetracycline:Tegoprazan 50mg bid, Bismuth potassium citrate capsules 0.6g bid,Cefuroxime tablets 500mg bid,Tetracycline 500mg tid,14 days.Evaluating the efficacy and safety of 14-Day bismuth quadruple therapy containing cefuroxime and tetracycline for Helicobacter pylori eradication.
14-day bismuth quadruple regimen containing cefuroxime and levofloxacinDrug
14-day bismuth quadruple regimen containing cefuroxime and levofloxacin:Tegoprazan 50mg bid, Bismuth potassium citrate capsules 0.6g bid,Cefuroxime tablets 500mg bid,Levofloxacin 500mg qd,14 days.
| Study group | Role | What they receive |
|---|---|---|
| 14-day bismuth quadruple regimen containing cefuroxime and tetracycline | Experimental | 14-day bismuth quadruple regimen containing cefuroxime and tetracycline:Tegoprazan (50mg twice/day before breakfast and supper), Bismuth potassium citrate capsule (0.6g twice/day before breakfast and supper), Cefuroxime tablets (500mg twice/day after breakfast and supper), Tetracycline (500mg three times/day after three meals);14 days. Receives: Drug: 14-day bismuth quadruple regimen containing cefuroxime and tetracycline |
| 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin | Active comparator | 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin:Tegoprazan (50mg twice/day before breakfast and supper), Bismuth potassium citrate capsule (0.6g twice/day before breakfast and supper), Cefuroxime tablets (500mg twice/day after breakfast and supper), Levofloxacin (500mg once/day after breakfast);14 days. Receives: Drug: 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups.
Measured: immediately after the procedure
Secondary outcomes (2)
Rate of adverse reactions
Rate of adverse reactions
Measured: immediately after the procedure
Patient compliance
Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yueyue Li, MD,PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351891
- Sponsor's protocol ID
- SHARE2402
- Status last verified
- Feb 2024
- First submitted
- 2 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang H, Kong Q, Zhang Q, Zhang L, Li R, Zhang T, Guo L, Wang X, Li X, Zhao H, Liu F, Guo Y, Zhai Z, Li M, Yang X, Zuo X, Yang X, Li Y. Efficacy and Safety of Cefuroxime-Tetracycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients: A Multicenter Randomized Controlled Trial. Helicobacter. 2025 Mar-Apr;30(2):e70033. doi: 10.1111/hel.70033.
PubMed 40237213
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin: A Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06351891
- Acronym / sponsor ID
- SHARE2402
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter Pylori Infection, Bismuth-containing quadruple therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Apr 2024 (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 researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 14-day bismuth quadruple regimen containing cefuroxime and tetracycline | Experimental | Drug: 14-day bismuth quadruple regimen containing cefuroxime and tetracycline14-day bismuth quadruple regimen containing cefuroxime and tetracycline:Tegoprazan (50mg twice/day before breakfast and supper), Bismuth potassium citrate capsule (0.6g twice/day before breakfast and supper), Cefuroxime tablets (500mg twice/day after breakfast and supper), Tetracycline (500mg three times/day after three meals);14 days. |
| 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin | Active comparator | Drug: 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin14-day bismuth quadruple regimen containing cefuroxime and levofloxacin:Tegoprazan (50mg twice/day before breakfast and supper), Bismuth potassium citrate capsule (0.6g twice/day before breakfast and supper), Cefuroxime tablets (500mg twice/day after breakfast and supper), Levofloxacin (500mg once/day after breakfast);14 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 years old, regardless of gender.
- History of penicillin allergy.
- Helicobacter pylori infection.
- Patients who have not previously received Helicobacter pylori eradication therapy.
Key exclusion criteria (7 listed)
- Medication history of bismuth and antibiotics within 4 weeks; PPIs and P-CABs within 2 weeks.
- Serious underlying diseases, such as liver insufficiency, renal insufficiency, malignant tumors, etc.
- Previous gastric or esophageal surgery.
- History of allergy to test drugs.
- Pregnant and lactating women and those unwilling to use contraception during the trial period.
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 |
|---|---|---|
| 14-day bismuth quadruple regimen containing cefuroxime and tetracycline14-day bismuth quadruple regimen containing cefuroxime and tetracycline:Tegoprazan 50mg bid, Bismuth potassium citrate capsules 0.6g bid,Cefuroxime tablets 500mg bid,Tetracycline 500mg tid,14 days.Evaluating the efficacy and safety of 14-Day bismuth quadruple therapy containing cefuroxime and tetracycline for Helicobacter pylori eradication. | Drug | 14-day bismuth quadruple regimen containing cefuroxime and tetracycline |
| 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin14-day bismuth quadruple regimen containing cefuroxime and levofloxacin:Tegoprazan 50mg bid, Bismuth potassium citrate capsules 0.6g bid,Cefuroxime tablets 500mg bid,Levofloxacin 500mg qd,14 days. | Drug | 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin |
Primary outcome
Eradication rate
Time frame: immediately after the procedure
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups.
2 secondary outcomes
Rate of adverse reactions
Time frame: immediately after the procedure
Patient compliance
Time frame: immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Derived from this study: PubMed 40237213Wang H, Kong Q, Zhang Q, Zhang L, Li R, Zhang T, Guo L, Wang X, Li X, Zhao H, Liu F, Guo Y, Zhai Z, Li M, Yang X, Zuo X, Yang X, Li Y. Efficacy and Safety of Cefuroxime-Tetracycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients: A Multicenter Randomized Controlled Trial. Helicobacter. 2025 Mar-Apr;30(2):e70033. doi: 10.1111/hel.70033.
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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.
Yueyue Li, MD,PhD principal investigator
Qilu Hospital of Shandong University
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 14-day bismuth quadruple regimen containing cefuroxime and tetracycline and 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin in people with Helicobacter Pylori Infection, run by Qilu Hospital of Shandong University at 1 site in China.
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 7 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 8 Apr 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueyue Li, MD,PhD (86-18560089751, lyynqj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate (time frame: immediately after the procedure). 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 NCT06351891, which also lists 1 linked publication.
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 8 Apr 2024.