Helicobacter Pylori InfectionNCT04723472
Bismuth Quadruple Therapy With Cefuroxime for Helicobacter Pylori Eradication Treatment
A study testing Cefuroxime containing bismuth quadruple treatment and Classic bismuth quadruple treatment in people with Helicobacter Pylori Infection, run by Shanghai East Hospital at 1 site in China.
Trial summary
To observe the efficacy of cefuroxime-containing bismuth quadruple regimen in the eradication treatment of Helicobacter pylori, and to evaluate whether it can be used as a remedial treatment for Helicobacter pylori after initial or repeated treatment failure. 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?
- Cefuroxime containing bismuth quadruple treatment and Classic bismuth quadruple treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Dec 2025
- Phase
- Interventional
- 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
- Employees, family members, and patients with positive C13 breath test in our hospital;
- Has received one or more previous Helicobacter pylori eradication therapy (no use of cefuroxime or tetracycline), and the result is still positive by C13 breath test;
- Willing to undergo gastroscopy and HP cultivation and identification;
- Age 18-70, gender unlimited;
- Willing to participate in and cooperate with the study, and willing to sign the informed consent.
Who cannot join
- Drugs that may affect the study results, such as PPI, H2 blockers, bismuth agents, antibiotics, etc. were taken in the 4 weeks before enrollment;
- Patients with gastrointestinal malignancy tumor;
- Patients with gastrinoma;
- After gastric or esophageal surgery;
- Suffers from serious diseases of the heart, lung, kidney, liver, blood, nervous system, endocrine system or mental system;
- Patients with contraindications or previous allergic reactions to the drugs used in this study;
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- Pregnant or breastfeeding women;
- Patients with other medical conditions that may increase the treatment side effects;
- Those who cannot give informed consent;
- Has participated in other drug trials within 3 months;
- Not considered suitable for participants by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Randomized Controlled Study of Bismuth Quadruple Therapy With Cefuroxime as Rescue Therapy for Helicobacter Pylori Infection
To observe the efficacy of cefuroxime-containing bismuth quadruple regimen in the eradication treatment of Helicobacter pylori, and to evaluate whether it can be used as a remedial treatment for Helicobacter pylori after initial or repeated treatment failure.
Read the detailed description
Introducing cefuroxime into the remedy treatment of Helicobacter pylori, on the one hand, the investigators will observe whether cefuroxime can replace tetracycline like amoxicillin, on the other hand, the investigators will observe whether it can reduce the rate of adverse effects caused by tetracycline and avoid the allergy of penicillin. If the experiment is successful, it will provide an effective and safe second-line treatment for the majority of patients with failed treatment of Helicobacter pylori.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Cefuroxime containing bismuth quadruple treatment, Classic bismuth quadruple treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefuroxime containing bismuth quadruple treatmentDrug
Cefuroxime containing bismuth quadruple treatment:
Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Cefuroxime 500mg bid po, Metronidazole 400mg tid po Treatment duration is 14 days.
Classic bismuth quadruple treatmentDrug
Classic bismuth quadruple treatment:
Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Tetracycline 500mg qid po, Metronidazole 400mg tid po Treatment duration is 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Classic bismuth quadruple treatment group | Active comparator | Not described Receives: Drug: Classic bismuth quadruple treatment |
| Cefuroxime containing bismuth quadruple treatment group | Experimental | Not described Receives: Drug: Cefuroxime containing bismuth quadruple treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of success rates after 14 days of eradicate treatment with helicobacter pylori using a bismuth quadruple regimen containing cefuroxime and a classic bismuth quadruple regimen
The comparison of eradication rate (0-100%), it is better to have a higher eradication rate.
Measured: The duration of treatment is 14 days. A C13 UBT will be performed 1 month after treatment.
Secondary outcomes (3)
The Success rate of cefuroxime-containing bismuth quadruple regimen in the treatment of refractory Helicobacter pylori after 14 days
The eradication rate of new regimen in refractory Helicobacter pylori treatment (0-100%)
Measured: A C13 UBT will be performed 1 month after treatment.
In vitro culture and drug sensitivity test of Helicobacter pylori were conducted to observe the drug resistance rate of Helicobacter pylori to cefuroxime, tetracycline and metronidazole.
The drug resistance rate of Helicobacter pylori to cefuroxime, tetracycline and metronidazole（0-100%）
Measured: before the treatment
Adverse effect rate and safety of cefuroxime-containing bismuth quadruple regimen and classical bismuth quadruple regimen in patients with refractory Helicobacter pylori.
questionnaire ; follow-up visit
Measured: one month after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Aug 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Want to modify the study further
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meidong Xu, Study director, ShanghaiDongfang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723472
- Sponsor's protocol ID
- 2020/041
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Guildline in patient consent form
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomized Controlled Study of Bismuth Quadruple Therapy With Cefuroxime as Rescue Therapy for Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT04723472
- Acronym / sponsor ID
- 2020/041
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Want to modify the study further
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jan 2021 (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.
To observe the efficacy of cefuroxime-containing bismuth quadruple regimen in the eradication treatment of Helicobacter pylori, and to evaluate whether it can be used as a remedial treatment for Helicobacter pylori after initial or repeated treatment failure.
Detailed description
Introducing cefuroxime into the remedy treatment of Helicobacter pylori, on the one hand, the investigators will observe whether cefuroxime can replace tetracycline like amoxicillin, on the other hand, the investigators will observe whether it can reduce the rate of adverse effects caused by tetracycline and avoid the allergy of penicillin. If the experiment is successful, it will provide an effective and safe second-line treatment for the majority of patients with failed treatment of Helicobacter pylori.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic bismuth quadruple treatment group | Active comparator | Drug: Classic bismuth quadruple treatment |
| Cefuroxime containing bismuth quadruple treatment group | Experimental | Drug: Cefuroxime containing bismuth quadruple treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Employees, family members, and patients with positive C13 breath test in our hospital;
- Has received one or more previous Helicobacter pylori eradication therapy (no use of cefuroxime or tetracycline), and the result is still positive by C13 breath test;
- Willing to undergo gastroscopy and HP cultivation and identification;
- Age 18-70, gender unlimited;
- Willing to participate in and cooperate with the study, and willing to sign the informed consent.
Key exclusion criteria (11 listed)
- Drugs that may affect the study results, such as PPI, H2 blockers, bismuth agents, antibiotics, etc. were taken in the 4 weeks before enrollment;
- Patients with gastrointestinal malignancy tumor;
- Patients with gastrinoma;
- After gastric or esophageal surgery;
- Suffers from serious diseases of the heart, lung, kidney, liver, blood, nervous system, endocrine system or mental system;
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 |
|---|---|---|
| Cefuroxime containing bismuth quadruple treatmentCefuroxime containing bismuth quadruple treatment: Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Cefuroxime 500mg bid po, Metronidazole 400mg tid po Treatment duration is 14 days. | Drug | Cefuroxime containing bismuth quadruple treatment group |
| Classic bismuth quadruple treatmentClassic bismuth quadruple treatment: Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Tetracycline 500mg qid po, Metronidazole 400mg tid po Treatment duration is 14 days. | Drug | Classic bismuth quadruple treatment group |
Primary outcome
Comparison of success rates after 14 days of eradicate treatment with helicobacter pylori using a bismuth quadruple regimen containing cefuroxime and a classic bismuth quadruple regimen
Time frame: The duration of treatment is 14 days. A C13 UBT will be performed 1 month after treatment.
The comparison of eradication rate (0-100%), it is better to have a higher eradication rate.
3 secondary outcomes
The Success rate of cefuroxime-containing bismuth quadruple regimen in the treatment of refractory Helicobacter pylori after 14 days
Time frame: A C13 UBT will be performed 1 month after treatment.
In vitro culture and drug sensitivity test of Helicobacter pylori were conducted to observe the drug resistance rate of Helicobacter pylori to cefuroxime, tetracycline and metronidazole.
Time frame: before the treatment
Adverse effect rate and safety of cefuroxime-containing bismuth quadruple regimen and classical bismuth quadruple regimen in patients with refractory Helicobacter pylori.
Time frame: one month after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No. Guildline in patient consent form
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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.
Meidong Xu study director
ShanghaiDongfang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefuroxime containing bismuth quadruple treatment and Classic bismuth quadruple treatment in people with Helicobacter Pylori Infection, run by Shanghai East Hospital 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 5 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: paused, as of the sponsor's last update on 14 Nov 2022. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of success rates after 14 days of eradicate treatment with helicobacter pylori using a bismuth quadruple regimen containing cefuroxime and a classic bismuth quadruple regimen (time frame: The duration of treatment is 14 days. A C13 UBT will be performed 1 month after treatment.). 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 14 Nov 2022.