Helicobacter Pylori InfectionPhase 4NCT03832465
Intraluminal Mono-antibiotic Therapy for Helicobacter Pylori Infection - A Comparison of Levofloxacin Powder and Levofloxacin Solution
A Phase 4 study testing Levofloxacin film-coated tablet and Levofloxacin intravenous solution in people with Helicobacter Pylori Infection, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Helicobacter pylori (H. pylori) is an important causal factor of chronic gastritis, peptic ulcer disease, gastric cancer and gastric lymphoma. The World Health Organization classified H. pylori as a Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the above diagnosis for patient with H. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Levofloxacin film-coated tablet and Levofloxacin intravenous solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jun 2019to 27 Dec 2020
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 20 years and 75 years
- Patients have H. pylori infection and have not treated with oral antibiotics
- Patients are willing to receive the intraluminal therapy. The written informed consents will be obtained from all patients prior to enrollment.
Who cannot join
- Children and teenagers aged less than 20 years or adult greater than 75 years
- Contraindication for endoscopic examination or food retention in the gastric lumen.
- History of gastrectomy; Gastroduodenal stenosis、deformity or obstruction; Gastroduodenal malignancy, including adenocarcinoma and lymphoma
- Contraindication to treatment drugs: previous allergic reaction to Proton pump inhibitors, Amoxicillin, Levofloxacin, Acetylcystein, and pregnant or lactating women
- Severe concurrent acute or chronic illness: renal failure, decompensated cirrhosis of liver, incurable malignant disease
- Patients who cannot give informed consent by himself or herself.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
Taipei, 10449
About this study
Official title: Visiting Staff, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
Helicobacter pylori (H. pylori) is an important causal factor of chronic gastritis, peptic ulcer disease, gastric cancer and gastric lymphoma. The World Health Organization classified H. pylori as a Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the above diagnosis for patient with H. pylori infection. The eradication of H. pylori can reduce the recurrence rate of peptic ulcer disease and even has the potential to prevent gastric cancer. H. pylori is the most common chronic bacterial infection in humans. The prevalence of H. pylori is about 30-50% in the Western adult population. It is estimated that about 50% of people are infected with this bacterium in Taiwan.
Triple therapy which contains a proton pump inhibitor and two antibiotics among clarithromycin, amoxicillin, and metronidazole is the most commonly used regimen for H. pylori eradication. The treatment duration is 7 to 14 days. However, the eradication rate of standard triple therapy has fallen below 80% in many countries due to the worldwide increasing prevalence of antibiotic resistant strains.
Read more
Several strategies have been proposed to increase the eradication rate in the first line therapy or as a rescue therapy, including extending the treatment duration to 14 days, increasing the doses of antibiotics, the use of four or even five drugs regimen (sequential, concomitant, quadruple or quintuple therapy), and other antibiotics such as levofloxacin. However, these therapies may increase the side effects and costs of treatment, decrease the compliance of patients and increase the rate of worldwide antibiotic resistance steadily. The WHO has listed H. Pylori as one of 16 antibiotic-resistant bacteria that have the greatest threat to human health in February, 2017.
The most commonly used oral antibiotics for the treatment of H. pylori are Amoxicillin、Clarithromycin、Metronidazole、Levofloxacin and Tetracycline.
However, with the increasing rates of antibiotic-resistance for Clarithromycin and Metronidazole, the Clarithromycin and Metronidazole were replaced by Levofloxacin as a first line or second line treatment in some area. However, the eradication rate of Levofloxacin-containing triple therapy is suboptimal in many countries. The investigators aim to compare the efficacy of different formulation between Levofloxacin Powder and Levofloxacin Solution in the Intraluminal levofloxacin therapy, and to improve the eradication efficacy of one-week Levofloxacin-containing triple therapy via the Intraluminal therapy.
Read the detailed description
During the endoscopic examination, patient is sedated with intravenous Dormicum 5mg (5mg/1ml/amp), the vital signs will be closely monitored by physiological monitor (PHILIPS SureSigns VM6). The treatment will be terminated immediately if unstable vital sign detected or if patient asks for termination. Patients will receive tests to evaluate H. pylori colonization in the gastric cardia (UFT300) and duodenal bulb (CLO). With endoscope apparatus, the gastric mucus is irrigated with acetylcysteine solution and the pH value of gastric juice will be measured with the pH test strips before irrigation and after irrigation.
The investigators randomly assigned medicaments containing different formulation (powder or solution ) of levofloxacin to dispense on the surface of gastric mucosa and duodenal mucosa of duodenal bulb. After the intraluminal therapy, patients will rest for 30 to 60 minutes and go home if the effect of sedation subsided. Patients can take meal if no abdominal discomfort. C13-Urea breath test (UBT) will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy. Patients failed to achieve intraluminal eradication of H. pylori will be randomly assigned to 7-day or 14-day levofloxacin-containing triple therapy (levofloxacin 500 mg once daily, amoxicillin 1 g twice daily, and esomeprazole 40 mg twice daily). The C13-UBT will be used to assess the existence of H. pylori 6 weeks after the oral antibiotic therapy. The overall eradication rates of the intraluminal therapy plus the oral antibiotics therapies will be evaluated.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Levofloxacin film-coated tablet, Levofloxacin intravenous solution
- Keywords
- Levofloxacin, Amoxicillin, Proton pump inhibitor, Helicobacter Pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin film-coated tabletDrug
Also called Leflodal film-coated tablet
50 participants are randomly assigned to receive intraluminal eradication of H. pylori.
with medicaments containing levofloxacin powder or levofloxacin solution.
Levofloxacin intravenous solutionDrug
Also called Cravit intravenous solution
50 participants are randomly assigned to receive intraluminal eradication of H. pylori.
with medicaments containing levofloxacin powder or levofloxacin solution.
| Study group | Role | What they receive |
|---|---|---|
| Intraluminal Levofloxacin powder therapy | Experimental | Group A Crashed powder of film-coated Levofloxacin Tablet (1 gm) for the Intraluminal therapy Receives: Drug: Levofloxacin film-coated tablet |
| Intraluminal Levofloxacin solution therapy | Active comparator | Group B Intravenous solution of Levofloxacin (1 gm) for the Intraluminal therapy Receives: Drug: Levofloxacin intravenous solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of the intraluminal Levofloxacin therapy
A Comparison of different formulation between Levofloxacin Powder and Levofloxacin solution
Measured: C13-UBT will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy.
Secondary outcomes (3)
Incidence of adverse effects of the intraluminal Levofloxacin therapy
A Comparison of different formulation between Levofloxacin Powder and Levofloxacin solution
Measured: within 7 days after finishing the intraluminal therapies
Eradication rates of 7-day or 14-day levofloxacin-containing triple therapy
A Comparison of the eradication rates of 7-day or 14-day levofloxacin-containing triple therapy after intraluminal therapy
Measured: C13-UBT will be used to assess the existence of H. pylori 6 weeks after the levofloxacin-containing triple herapies.
The overall eradication rate
The overall eradication rates of the intraluminal therapy plus oral antibiotics therapies were evaluated.
Measured: 3-6 months after finishing the intraluminal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start14 Jun 2019
- Primary completion1 Jul 2020
- Study completion27 Dec 2020
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 50 participants are randomly assigned to receive intraluminal eradication of H. pylori. with medicaments containing levofloxacin powder or levofloxacin solution. Patients failed to achieve intraluminal eradication of H. pylori will be randomly assigned to 7-day or 14-day levofloxacin-containing triple therapy (levofloxacin 500 mg once daily, amoxicillin 1 g twice daily, and esomeprazole 40 mg twice daily).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tai-cherng Liou, MD, Mackay Memorial Hospital
- Investigators
- Tai-cherng Liou, MD, Principal investigator, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832465
- Sponsor's protocol ID
- 18MMHIS168
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2019
- Last updated
- 5 Feb 2021
- 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 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visiting Staff, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
- ClinicalTrials.gov ID
- NCT03832465
- Acronym / sponsor ID
- 18MMHIS168
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Levofloxacin, Amoxicillin, Proton pump inhibitor, Helicobacter Pylori
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 27 Dec 2020 (actual)
- First posted
- 6 Feb 2019 (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.
Helicobacter pylori (H. pylori) is an important causal factor of chronic gastritis, peptic ulcer disease, gastric cancer and gastric lymphoma. The World Health Organization classified H. pylori as a Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the above diagnosis for patient with H. pylori infection. The eradication of H. pylori can reduce the recurrence rate of peptic ulcer disease and even has the potential to prevent gastric cancer. H. pylori is the most common chronic bacterial infection in humans. The prevalence of H. pylori is about 30-50% in the Western adult population. It is estimated that about 50% of people are infected with this bacterium in Taiwan.
Triple therapy which contains a proton pump inhibitor and two antibiotics among clarithromycin, amoxicillin, and metronidazole is the most commonly used regimen for H. pylori eradication. The treatment duration is 7 to 14 days. However, the eradication rate of standard triple therapy has fallen below 80% in many countries due to the worldwide increasing prevalence of antibiotic resistant strains.
Several strategies have been proposed to increase the eradication rate in the first line therapy or as a rescue therapy, including extending the treatment duration to 14 days, increasing the doses of antibiotics, the use of four or even five drugs regimen (sequential, concomitant, quadruple or quintuple therapy), and other antibiotics such as levofloxacin. However, these therapies may increase the side effects and costs of treatment, decrease the compliance of patients and increase the rate of worldwide antibiotic resistance steadily. The WHO has listed H. Pylori as one of 16 antibiotic-resistant bacteria that have the greatest threat to human health in February, 2017.
The most commonly used oral antibiotics for the treatment of H. pylori are Amoxicillin、Clarithromycin、Metronidazole、Levofloxacin and Tetracycline.
However, with the increasing rates of antibiotic-resistance for Clarithromycin and Metronidazole, the Clarithromycin and Metronidazole were replaced by Levofloxacin as a first line or second line treatment in some area. However, the eradication rate of Levofloxacin-containing triple therapy is suboptimal in many countries. The investigators aim to compare the efficacy of different formulation between Levofloxacin Powder and Levofloxacin Solution in the Intraluminal levofloxacin therapy, and to improve the eradication efficacy of one-week Levofloxacin-containing triple therapy via the Intraluminal therapy.
Detailed description
During the endoscopic examination, patient is sedated with intravenous Dormicum 5mg (5mg/1ml/amp), the vital signs will be closely monitored by physiological monitor (PHILIPS SureSigns VM6). The treatment will be terminated immediately if unstable vital sign detected or if patient asks for termination. Patients will receive tests to evaluate H. pylori colonization in the gastric cardia (UFT300) and duodenal bulb (CLO). With endoscope apparatus, the gastric mucus is irrigated with acetylcysteine solution and the pH value of gastric juice will be measured with the pH test strips before irrigation and after irrigation.
The investigators randomly assigned medicaments containing different formulation (powder or solution ) of levofloxacin to dispense on the surface of gastric mucosa and duodenal mucosa of duodenal bulb. After the intraluminal therapy, patients will rest for 30 to 60 minutes and go home if the effect of sedation subsided. Patients can take meal if no abdominal discomfort. C13-Urea breath test (UBT) will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy. Patients failed to achieve intraluminal eradication of H. pylori will be randomly assigned to 7-day or 14-day levofloxacin-containing triple therapy (levofloxacin 500 mg once daily, amoxicillin 1 g twice daily, and esomeprazole 40 mg twice daily). The C13-UBT will be used to assess the existence of H. pylori 6 weeks after the oral antibiotic therapy. The overall eradication rates of the intraluminal therapy plus the oral antibiotics therapies will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 50 participants are randomly assigned to receive intraluminal eradication of H. pylori. with medicaments containing levofloxacin powder or levofloxacin solution. Patients failed to achieve intraluminal eradication of H. pylori will be randomly assigned to 7-day or 14-day levofloxacin-containing triple therapy (levofloxacin 500 mg once daily, amoxicillin 1 g twice daily, and esomeprazole 40 mg twice daily).
| Arm | Type | Receives |
|---|---|---|
| Intraluminal Levofloxacin powder therapy | Experimental | Drug: Levofloxacin film-coated tabletGroup A Crashed powder of film-coated Levofloxacin Tablet (1 gm) for the Intraluminal therapy |
| Intraluminal Levofloxacin solution therapy | Active comparator | Drug: Levofloxacin intravenous solutionGroup B Intravenous solution of Levofloxacin (1 gm) for the Intraluminal therapy |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 20 years and 75 years
- Patients have H. pylori infection and have not treated with oral antibiotics
- Patients are willing to receive the intraluminal therapy. The written informed consents will be obtained from all patients prior to enrollment.
Key exclusion criteria (6 listed)
- Children and teenagers aged less than 20 years or adult greater than 75 years
- Contraindication for endoscopic examination or food retention in the gastric lumen.
- History of gastrectomy; Gastroduodenal stenosis、deformity or obstruction; Gastroduodenal malignancy, including adenocarcinoma and lymphoma
- Contraindication to treatment drugs: previous allergic reaction to Proton pump inhibitors, Amoxicillin, Levofloxacin, Acetylcystein, and pregnant or lactating women
- Severe concurrent acute or chronic illness: renal failure, decompensated cirrhosis of liver, incurable malignant disease
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 film-coated tabletAlso: Leflodal film-coated tablet50 participants are randomly assigned to receive intraluminal eradication of H. pylori. with medicaments containing levofloxacin powder or levofloxacin solution. | Drug | Intraluminal Levofloxacin powder therapy |
| Levofloxacin intravenous solutionAlso: Cravit intravenous solution50 participants are randomly assigned to receive intraluminal eradication of H. pylori. with medicaments containing levofloxacin powder or levofloxacin solution. | Drug | Intraluminal Levofloxacin solution therapy |
Primary outcome
Eradication rate of the intraluminal Levofloxacin therapy
Time frame: C13-UBT will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy.
A Comparison of different formulation between Levofloxacin Powder and Levofloxacin solution
3 secondary outcomes
Incidence of adverse effects of the intraluminal Levofloxacin therapy
Time frame: within 7 days after finishing the intraluminal therapies
Eradication rates of 7-day or 14-day levofloxacin-containing triple therapy
Time frame: C13-UBT will be used to assess the existence of H. pylori 6 weeks after the levofloxacin-containing triple herapies.
The overall eradication rate
Time frame: 3-6 months after finishing the intraluminal therapy
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 5 Feb 2021.
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
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.
Tai-cherng Liou, MD principal investigator
Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital
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 Levofloxacin film-coated tablet and Levofloxacin intravenous solution in people with Helicobacter Pylori Infection, run by Mackay Memorial Hospital 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 3 inclusion and 6 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 5 Feb 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 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 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?
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 of the intraluminal Levofloxacin therapy (time frame: C13-UBT will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy.). 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 Feb 2021.