Helicobacter Pylori InfectionNCT04991584
Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori Infection
A study testing Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole , in people with Helicobacter Pylori Infection, run by Shandong University at 1 site in China.
Trial summary
The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates. 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?
- Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole ,
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2021to 1 Jul 2022
- 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
- Patients aged 18-70 with persistent H. pylori infection.
- Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.
Who cannot join
- Patients unable or unwilling to receive gastroscopy.
- Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
- Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
- History of allergy to any of the drugs used in the study.
- Severe concomitant cardiovascular, respiratory, or endocrine diseases,clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
- Currently pregnant or lactating.
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- Severe neurologic or psychiatric disorders.
- Alcohol abuse or drug addiction.
- Patients with compliance lower than 90% in any previous treatment are not included.
- Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori: A Pilot Study
The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.
Read the detailed description
Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.
Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with two or more treatment failure, and then evaluates whether adverse effects are tolerable. .
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole ,
- Keywords
- Concomitant Therapy, Rescue treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole ,Drug
Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment.
| Study group | Role | What they receive |
|---|---|---|
| 14d concomitant therapy | Experimental | Patients will receive a 14-day concomitant therapy Option 1:Amoxicillin+Tetracycline+Furazolidone+Vonoprazan fumarate or Esomeprazole Option 2: Amoxicillin+Furazolidone+Levofloxacin+Vonoprazan fumarate or Esomeprazole Option 3: Amoxicillin+Tetracycline+Levofloxacin+Vonoprazan fumarate or Esomeprazole Option 4: Amoxicillin+Clarithromycin+Levofloxacin+Vonoprazan fumarate or Esomeprazole Three options are selected according to the actual situation. Receives: Drug: Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole , |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rates
Six weeks after completion of treatment,number of patients get H.pylori eradicated will be investigated.Then eradication rate will be calculated by using intention-to-treat analysis and per-protocol analysis.
results will be investigated by an independent researcher.Then eradication rate in each group will be calculated by using intention-to-treat analysis and per-protocol analysis. of Helicobacter pylori infection. The ITT analysis includes all the patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow up.
Measured: 6 month
Secondary outcomes (2)
The rate of adverse events happening
At the follow-up,adverse events complained by patients will be recorded by an independent researcher#meanwhile a 8 point visual analog scale (VAS) was used to evaluate severity of adverse events.
Measured: 6 month
Compliance of patients
compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start4 Aug 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991584
- Sponsor's protocol ID
- 2021-SDU-QILU-G003
- Status last verified
- Aug 2021
- First submitted
- 3 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori: A Pilot Study
- ClinicalTrials.gov ID
- NCT04991584
- Acronym / sponsor ID
- 2021-SDU-QILU-G003
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Concomitant Therapy, Rescue treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 4 Aug 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 5 Aug 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.
The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.
Detailed description
Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.
Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with two or more treatment failure, and then evaluates whether adverse effects are tolerable. .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14d concomitant therapy | Experimental | Drug: Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole ,Patients will receive a 14-day concomitant therapy Option 1:Amoxicillin+Tetracycline+Furazolidone+Vonoprazan fumarate or Esomeprazole Option 2: Amoxicillin+Furazolidone+Levofloxacin+Vonoprazan fumarate or Esomeprazole Option 3: Amoxicillin+Tetracycline+Levofloxacin+Vonoprazan fumarate or Esomeprazole Option 4: Amoxicillin+Clarithromycin+Levofloxacin+Vonoprazan fumarate or Esomeprazole Three options are selected according to the actual situation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-70 with persistent H. pylori infection.
- Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.
Key exclusion criteria (10 listed)
- Patients unable or unwilling to receive gastroscopy.
- Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
- Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
- History of allergy to any of the drugs used in the study.
- Severe concomitant cardiovascular, respiratory, or endocrine diseases,clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
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 |
|---|---|---|
| Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole ,Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. | Drug | 14d concomitant therapy |
Primary outcome
Eradication rates
Time frame: 6 month
Six weeks after completion of treatment,number of patients get H.pylori eradicated will be investigated.Then eradication rate will be calculated by using intention-to-treat analysis and per-protocol analysis. results will be investigated by an independent researcher.Then eradication rate in each group will be calculated by using intention-to-treat analysis and per-protocol analysis. of Helicobacter pylori infection. The ITT analysis includes all the patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow up.
2 secondary outcomes
The rate of adverse events happening
Time frame: 6 month
Compliance of patients
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole , in people with Helicobacter Pylori Infection, run by 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 2 inclusion and 10 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 5 Aug 2021. 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?
Eradication rates (time frame: 6 month). 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 5 Aug 2021.