Helicobacter Pylori EradicationNCT05850117
Efficacies of Tetracycline-levofloxacin, Standard Bismuth, Amoxicillin-levofloxacin Quadruple Therapy for H.p
A study testing esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin, esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole and esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin in people with Helicobacter Pylori Eradication, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
1. Compare the efficacy of "Tetracycline combined with levofloxacin quadruple therapy", "standard tincture quadruple therapy" and "amoxicillin combined with levofloxacin quadruple therapy" on the second line of Helicobacter pylori sterilization. 2. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Helicobacter Pylori Eradication
- What is being tested?
- esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin, esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole and esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Feb 2020to 31 Dec 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 20 years old
- subject was failure for the first line therapy of Helicobacter pylori
Who cannot join
- Those who are allergic to the drugs used in this study
- Those who have had a stomach surgery
- Those who have antibiotics within four weeks of treatment
- Those who have severe cirrhosis, uremia or malignancy
- Those who are a pregnant woman or a woman who breastfeeds
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, 807
Deng-Chyang Wu, MD,PHD, 886-7-3121101 ext. 7451, dechwu@yahoo.com
About this study
Official title: Efficacies of Tetracycline-levofloxacin Quadruple Therapy, Standard Bismuth Quadruple Therapy and Amoxicillin-levofloxacin Quadruple Therapy in the Second-line Treatment of H Pylori Infection
- Compare the efficacy of "Tetracycline combined with levofloxacin quadruple therapy", "standard tincture quadruple therapy" and "amoxicillin combined with levofloxacin quadruple therapy" on the second line of Helicobacter pylori sterilization.
- To investigate the drug resistance of Helicobacter pylori and the host genotypes of CYP2C19 and IL-1B-511 on the sterilizing effect of three second-line Helicobacter pylori.
Read the detailed description
The "standard tincture quadruple therapy" and the "proton pump inhibitor combined with fluoroquinolone and amoxicillin triple therapy" recommended by the 5th Mazdock-Florence Consensus Conference on the second line of Helicobacter pylori treatment The sterilization rate is not ideal (less than 80%). Recently, we have developed a "Tetracycline combined with levofloxacin quadruple therapy" for first-line treatment failure of H. pylori infection, with a relatively high sterilization rate (> 95%). A randomized controlled trial confirmed that the elimination rate of "Tetracycline combined with levofloxacin quadruple therapy" was better than "proton pump inhibitor combined with fluoroquinolone" after "standard triple therapy" and "non-tank tetratherapy" sterilization failure. Triple therapy with amoxicillin.
- Conditions
- Helicobacter Pylori Eradication
- Being tested
- esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin, esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole, esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacinDrug
Tetracycline combined with levofloxacin quadruple therapy
esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazoleDrug
standard tincture quadruple therapy
esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacinDrug
amoxicillin combined with levofloxacin quadruple therapy
| Study group | Role | What they receive |
|---|---|---|
| Tetracycline combined with levofloxacin quadruple therapy | Active comparator | esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ tetracycline 500mg four times a day+ levofloxacin 500mg once a day Receives: Drug: esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin |
| standard tincture quadruple therapy | Active comparator | esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day
+ tetracycline 500mg four times a day + metronidazole 250mg four times a day Receives: Drug: esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole |
| amoxicillin combined with levofloxacin quadruple therapy | Active comparator | esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ amoxicillin 500mg four times a day+ levofloxacin 500mg once a day Receives: Drug: esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of Helicobacter pylori
evalute eradication outcome by 13C urea breath test
Measured: 6 week after finish study drugs
Secondary outcomes (1)
genotype analysis
CYP2C19 genotype, IL-1B-511 genotype
Measured: 2 weeks after finishing study drgus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start10 Feb 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori EradicationStudies 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
- Model description
- 1.Tetracycline combined with levofloxacin quadruple therapy 2. standard tincture quadruple therapy 2. amoxicillin combined with levofloxacin quadruple therapy
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DENG-CHYANG WU, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850117
- Sponsor's protocol ID
- KMUHIRB-F(I)-20190136
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacies of Tetracycline-levofloxacin Quadruple Therapy, Standard Bismuth Quadruple Therapy and Amoxicillin-levofloxacin Quadruple Therapy in the Second-line Treatment of H Pylori Infection
- ClinicalTrials.gov ID
- NCT05850117
- Acronym / sponsor ID
- KMUHIRB-F(I)-20190136
- Conditions
- Helicobacter Pylori Eradication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 May 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.
- Compare the efficacy of "Tetracycline combined with levofloxacin quadruple therapy", "standard tincture quadruple therapy" and "amoxicillin combined with levofloxacin quadruple therapy" on the second line of Helicobacter pylori sterilization.
- To investigate the drug resistance of Helicobacter pylori and the host genotypes of CYP2C19 and IL-1B-511 on the sterilizing effect of three second-line Helicobacter pylori.
Detailed description
The "standard tincture quadruple therapy" and the "proton pump inhibitor combined with fluoroquinolone and amoxicillin triple therapy" recommended by the 5th Mazdock-Florence Consensus Conference on the second line of Helicobacter pylori treatment The sterilization rate is not ideal (less than 80%). Recently, we have developed a "Tetracycline combined with levofloxacin quadruple therapy" for first-line treatment failure of H. pylori infection, with a relatively high sterilization rate (> 95%). A randomized controlled trial confirmed that the elimination rate of "Tetracycline combined with levofloxacin quadruple therapy" was better than "proton pump inhibitor combined with fluoroquinolone" after "standard triple therapy" and "non-tank tetratherapy" sterilization failure. Triple therapy with amoxicillin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1.Tetracycline combined with levofloxacin quadruple therapy 2. standard tincture quadruple therapy 2. amoxicillin combined with levofloxacin quadruple therapy
| Arm | Type | Receives |
|---|---|---|
| Tetracycline combined with levofloxacin quadruple therapy | Active comparator | Drug: esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacinesomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ tetracycline 500mg four times a day+ levofloxacin 500mg once a day |
| standard tincture quadruple therapy | Active comparator | Drug: esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazoleesomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day + tetracycline 500mg four times a day + metronidazole 250mg four times a day |
| amoxicillin combined with levofloxacin quadruple therapy | Active comparator | Drug: esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacinesomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ amoxicillin 500mg four times a day+ levofloxacin 500mg once a day |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 20 years old
- subject was failure for the first line therapy of Helicobacter pylori
Key exclusion criteria (5 listed)
- Those who are allergic to the drugs used in this study
- Those who have had a stomach surgery
- Those who have antibiotics within four weeks of treatment
- Those who have severe cirrhosis, uremia or malignancy
- Those who are a pregnant woman or a woman who breastfeeds
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 |
|---|---|---|
| esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacinTetracycline combined with levofloxacin quadruple therapy | Drug | Tetracycline combined with levofloxacin quadruple therapy |
| esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazolestandard tincture quadruple therapy | Drug | standard tincture quadruple therapy |
| esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacinamoxicillin combined with levofloxacin quadruple therapy | Drug | amoxicillin combined with levofloxacin quadruple therapy |
Primary outcome
the rate of Helicobacter pylori
Time frame: 6 week after finish study drugs
evalute eradication outcome by 13C urea breath test
1 secondary outcome
genotype analysis
Time frame: 2 weeks after finishing study drgus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin, esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole and esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin in people with Helicobacter Pylori Eradication, run by Kaohsiung Medical University at 1 site in Taiwan.
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 2 inclusion and 5 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 9 May 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 Taiwan. 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?
Contact Deng-Chyang Wu, MD, PhD (88673121101 ext. 7451, dechwu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of Helicobacter pylori (time frame: 6 week after finish study drugs). 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 9 May 2023.