HelicobacterPhase 3NCT03148366
Comparison of the Levofloxacin Sequential Therapy and Quadruple Therapy in Second Line Treatment for HP
A Phase 3 study testing Levofloxacin based sequential therapy and bismuth quadruple therapy for 10 days (BQ) in people with Helicobacter, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Objectives: Eradication of H. pylori infection could reduce the occurence or recurrence of gastric cancer and peptic ulcer diseases. However, it was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter
- What is being tested?
- Levofloxacin based sequential therapy and bismuth quadruple therapy for 10 days (BQ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 2 sitesTaiwan
- Study dates
- Feb 2015to Dec 2020
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. H. pylori infected patients who failed from first line standard triple therapy with clarithromycin, amoxicillin, and a proton pump inhibitor were eligible in this study
Who cannot join
- children and teenagers aged less than 20 years,
- history of gastrectomy,
- gastric malignancy, including adenocarcinoma and lymphoma,
- previous allergic reaction to antibiotics (bismuth, metronidazole, levofloxacin, tetracycline) and PPI (esomeprazole),
- contraindication to treatment drugs,
- pregnant or lactating women,
- severe concurrent disease, or
- Unwilling to accept random assignment of subjects
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital
Taipei
National Taiwan University Hospital, Yunlin branch
Yunlin
About this study
Official title: Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Bismuth Quadruple Therapy in the Second Line and Third Line Therapy for Helicobacter Pylori Infection- A Multi-center Randomized Trial
Objectives: Eradication of H. pylori infection could reduce the occurence or recurrence of gastric cancer and peptic ulcer diseases. However, it was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy. Bismuth quadruple therapy and triple therapy containing levofloxacin are currently the recommended rescue therapies in the second line and third line treatment. Recently, our pilot study showed that modified sequential therapy containing levofloxacin achieved high eradication rate (95%) in the second line therapy. The regimen includes a PPI plus amoxicillin for 5-7 days, followed by a PPI plus levofloxacin and metronidazole for another 5-7 days. However, whether this modified sequential therapy containing levofloxacin is more effective than bismuth quadruple therapy in the second line and third line treatment remains unknown. Besides, the impact of these regimens on the antibiotic resistance , microbiota of gut flora, and metabolic factors remains unknown.
Aims: Therefore, the investigators aimed to
- compare the eradication rates and long term re-infection rates of sequential therapy containing levofloxacin for 14 days versus bismuth quadruple therapy for 10 days in the second line and third line treatment
- assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
- assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
- assess the impact of eradication therapy on the metabolic factors
Read the detailed description
Methods:
This will be a multi-center, open labeled, randomized comparative trial with cross-over design Patients: Participants with refractory H. pylori infection after one eradication therapy
Testing for H. pylori infection Before Second Line Treatment : Any two positive of CLO test, histology, and culture or a positive UBT will be considered as H. pylori infected
After Second Line Treatment: C13-UBT will be used to assess the existence of H. pylori 6-8 weeks after first line therapy.
Long term reinfection: C13-UBT will be used to assess the recurrence of H. pylori 1 year after eradication therapy
Interventions:
Second line therapy: eligible patients will be randomized into one of the two groups Group (A): sequential therapy containing levofloxacin for 14 days (EAML) D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days
Group (B): bismuth quadruple therapy for 10 days (BQ) D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
Third line therapy: patients who fail from second line treatment will be rescue with the following treatment Group (A) Patient who fail from levofloxacin sequential therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
Group (B) Patient who fail from bismuth quadruple therapy will be retreated with levofloxacin sequential therapy for 14days D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days
Outcome Measurement:
Primary End Point: Eradication rate in the second line according to intention to treat (ITT) and per-protocol (PP) analysis in the two treatment groups
- Conditions
- Helicobacter
- Being tested
- Levofloxacin based sequential therapy, bismuth quadruple therapy for 10 days (BQ)
- Keywords
- Self Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin based sequential therapyDrug
D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days
bismuth quadruple therapy for 10 days (BQ)Drug
D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin based sequential therapy | Experimental | Levofloxacin based sequential therapy
: sequential therapy containing levofloxacin for 14 days D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days Receives: Drug: Levofloxacin based sequential therapy |
| bismuth quadruple therapy (BQ) | Active comparator | bismuth quadruple therapy for 10 days (BQ) D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days Receives: Drug: bismuth quadruple therapy for 10 days (BQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate after second line eradication therapy according to ITT analysis
The eradication status will be determined by urea breath test (UBT) at least 6 weeks after completion of the treatment. The delta value of UBT of 4 or less will be defined as negative and successful eradication.
Measured: 6 weeks after completion of treatment
Secondary outcomes (3)
Adverse effects during eradication therapy
adverse effects will be assessed by questionnaire
Measured: during treatment (2 weeks)
Long term eradication rate 1 year after eradication therapy
Long term eradication rates will be determined by UBT at 1 year after eradication therapy.
Measured: 1 year after treatment
changes of gut microbiota before and after eradication therapy
Fecal DNA will be extracted and 16S rRNA sequencing will be done. The changes in the alpha and beta diversity and the compositions of gut microbiota before and after HP eradication will be assessed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study startFeb 2015
- Primary completionDec 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HelicobacterStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Shiang Wu, Study chair, National Taiwan University HospitalJyh-Ming Liou, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148366
- Sponsor's protocol ID
- 201410001MINC
- Status last verified
- Mar 2017
- First submitted
- 30 Jan 2015
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The investigators will not share the data.
Publications
Liou JM, Chen CC, Chen MJ, Chen CC, Chang CY, Fang YJ, Lee JY, Hsu SJ, Luo JC, Chang WH, Hsu YC, Tseng CH, Tseng PH, Wang HP, Yang UC, Shun CT, Lin JT, Lee YC, Wu MS; Taiwan Helicobacter Consortium. Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2013 Jan 19;381(9862):205-13. doi: 10.1016/S0140-6736(12)61579-7. Epub 2012 Nov 16.
PubMed 23158886Liou JM, Chen CC, Chang CY, Chen MJ, Fang YJ, Lee JY, Chen CC, Hsu SJ, Hsu YC, Tseng CH, Tseng PH, Chang L, Chang WH, Wang HP, Shun CT, Wu JY, Lee YC, Lin JT, Wu MS; Taiwan Helicobacter Consortium. Efficacy of genotypic resistance-guided sequential therapy in the third-line treatment of refractory Helicobacter pylori infection: a multicentre clinical trial. J Antimicrob Chemother. 2013 Feb;68(2):450-6. doi: 10.1093/jac/dks407. Epub 2012 Oct 25.
PubMed 23099849Liou JM, Chen CC, Chen MJ, Chang CY, Fang YJ, Lee JY, Sheng WH, Wang HP, Wu MS, Lin JT. Empirical modified sequential therapy containing levofloxacin and high-dose esomeprazole in second-line therapy for Helicobacter pylori infection: a multicentre clinical trial. J Antimicrob Chemother. 2011 Aug;66(8):1847-52. doi: 10.1093/jac/dkr217. Epub 2011 May 31.
PubMed 21632579Liou JM, Jiang XT, Chen CC, Luo JC, Bair MJ, Chen PY, Chou CK, Fang YJ, Chen MJ, Chen CC, Lee JY, Yang TH, Yu CC, Kuo CC, Chiu MC, Chen CY, Shun CT, Hu WH, Tsai MH, Hsu YC, Tseng CH, Chang CY, Lin JT, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Second-line levofloxacin-based quadruple therapy versus bismuth-based quadruple therapy for Helicobacter pylori eradication and long-term changes to the gut microbiota and antibiotic resistome: a multicentre, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Mar;8(3):228-241. doi: 10.1016/S2468-1253(22)00384-3. Epub 2022 Dec 19.
PubMed 36549320
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Bismuth Quadruple Therapy in the Second Line and Third Line Therapy for Helicobacter Pylori Infection- A Multi-center Randomized Trial
- ClinicalTrials.gov ID
- NCT03148366
- Acronym / sponsor ID
- 201410001MINC
- Conditions
- Helicobacter
- Keywords
- Self Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 11 May 2017 (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.
Objectives: Eradication of H. pylori infection could reduce the occurence or recurrence of gastric cancer and peptic ulcer diseases. However, it was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy. Bismuth quadruple therapy and triple therapy containing levofloxacin are currently the recommended rescue therapies in the second line and third line treatment. Recently, our pilot study showed that modified sequential therapy containing levofloxacin achieved high eradication rate (95%) in the second line therapy. The regimen includes a PPI plus amoxicillin for 5-7 days, followed by a PPI plus levofloxacin and metronidazole for another 5-7 days. However, whether this modified sequential therapy containing levofloxacin is more effective than bismuth quadruple therapy in the second line and third line treatment remains unknown. Besides, the impact of these regimens on the antibiotic resistance , microbiota of gut flora, and metabolic factors remains unknown.
Aims: Therefore, the investigators aimed to
- compare the eradication rates and long term re-infection rates of sequential therapy containing levofloxacin for 14 days versus bismuth quadruple therapy for 10 days in the second line and third line treatment
- assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
- assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
- assess the impact of eradication therapy on the metabolic factors
Detailed description
Methods:
This will be a multi-center, open labeled, randomized comparative trial with cross-over design Patients: Participants with refractory H. pylori infection after one eradication therapy
Testing for H. pylori infection Before Second Line Treatment : Any two positive of CLO test, histology, and culture or a positive UBT will be considered as H. pylori infected
After Second Line Treatment: C13-UBT will be used to assess the existence of H. pylori 6-8 weeks after first line therapy.
Long term reinfection: C13-UBT will be used to assess the recurrence of H. pylori 1 year after eradication therapy
Interventions:
Second line therapy: eligible patients will be randomized into one of the two groups Group (A): sequential therapy containing levofloxacin for 14 days (EAML) D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days
Group (B): bismuth quadruple therapy for 10 days (BQ) D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
Third line therapy: patients who fail from second line treatment will be rescue with the following treatment Group (A) Patient who fail from levofloxacin sequential therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
Group (B) Patient who fail from bismuth quadruple therapy will be retreated with levofloxacin sequential therapy for 14days D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days
Outcome Measurement:
Primary End Point: Eradication rate in the second line according to intention to treat (ITT) and per-protocol (PP) analysis in the two treatment groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin based sequential therapy | Experimental | Drug: Levofloxacin based sequential therapyLevofloxacin based sequential therapy : sequential therapy containing levofloxacin for 14 days D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days |
| bismuth quadruple therapy (BQ) | Active comparator | Drug: bismuth quadruple therapy for 10 days (BQ)bismuth quadruple therapy for 10 days (BQ) D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. H. pylori infected patients who failed from first line standard triple therapy with clarithromycin, amoxicillin, and a proton pump inhibitor were eligible in this study
Key exclusion criteria (8 listed)
- children and teenagers aged less than 20 years,
- history of gastrectomy,
- gastric malignancy, including adenocarcinoma and lymphoma,
- previous allergic reaction to antibiotics (bismuth, metronidazole, levofloxacin, tetracycline) and PPI (esomeprazole),
- contraindication to treatment drugs,
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 |
|---|---|---|
| Levofloxacin based sequential therapyD1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days | Drug | Levofloxacin based sequential therapy |
| bismuth quadruple therapy for 10 days (BQ)D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days | Drug | bismuth quadruple therapy (BQ) |
Primary outcome
Eradication rate after second line eradication therapy according to ITT analysis
Time frame: 6 weeks after completion of treatment
The eradication status will be determined by urea breath test (UBT) at least 6 weeks after completion of the treatment. The delta value of UBT of 4 or less will be defined as negative and successful eradication.
3 secondary outcomes
Adverse effects during eradication therapy
Time frame: during treatment (2 weeks)
Long term eradication rate 1 year after eradication therapy
Time frame: 1 year after treatment
changes of gut microbiota before and after eradication therapy
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Results publication: PubMed 23158886Liou JM, Chen CC, Chen MJ, Chen CC, Chang CY, Fang YJ, Lee JY, Hsu SJ, Luo JC, Chang WH, Hsu YC, Tseng CH, Tseng PH, Wang HP, Yang UC, Shun CT, Lin JT, Lee YC, Wu MS; Taiwan Helicobacter Consortium. Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2013 Jan 19;381(9862):205-13. doi: 10.1016/S0140-6736(12)61579-7. Epub 2012 Nov 16.
- Results publication: PubMed 23099849Liou JM, Chen CC, Chang CY, Chen MJ, Fang YJ, Lee JY, Chen CC, Hsu SJ, Hsu YC, Tseng CH, Tseng PH, Chang L, Chang WH, Wang HP, Shun CT, Wu JY, Lee YC, Lin JT, Wu MS; Taiwan Helicobacter Consortium. Efficacy of genotypic resistance-guided sequential therapy in the third-line treatment of refractory Helicobacter pylori infection: a multicentre clinical trial. J Antimicrob Chemother. 2013 Feb;68(2):450-6. doi: 10.1093/jac/dks407. Epub 2012 Oct 25.
- Results publication: PubMed 21632579Liou JM, Chen CC, Chen MJ, Chang CY, Fang YJ, Lee JY, Sheng WH, Wang HP, Wu MS, Lin JT. Empirical modified sequential therapy containing levofloxacin and high-dose esomeprazole in second-line therapy for Helicobacter pylori infection: a multicentre clinical trial. J Antimicrob Chemother. 2011 Aug;66(8):1847-52. doi: 10.1093/jac/dkr217. Epub 2011 May 31.
- Derived from this study: PubMed 36549320Liou JM, Jiang XT, Chen CC, Luo JC, Bair MJ, Chen PY, Chou CK, Fang YJ, Chen MJ, Chen CC, Lee JY, Yang TH, Yu CC, Kuo CC, Chiu MC, Chen CY, Shun CT, Hu WH, Tsai MH, Hsu YC, Tseng CH, Chang CY, Lin JT, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Second-line levofloxacin-based quadruple therapy versus bismuth-based quadruple therapy for Helicobacter pylori eradication and long-term changes to the gut microbiota and antibiotic resistome: a multicentre, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Mar;8(3):228-241. doi: 10.1016/S2468-1253(22)00384-3. Epub 2022 Dec 19.
- Individual participant dataSharing planned: No. The investigators will not share the data.
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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.
Ming-Shiang Wu study chair
National Taiwan University Hospital
Jyh-Ming Liou principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levofloxacin based sequential therapy and bismuth quadruple therapy for 10 days (BQ) in people with Helicobacter, run by National Taiwan University Hospital at 2 sites 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 rate after second line eradication therapy according to ITT analysis (time frame: 6 weeks after completion 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 NCT03148366, which also lists 4 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 8 Jun 2022.