Helicobacter Pylori InfectionNCT03583476
The Impact of Antibiotics MIC Value on the Efficacy of Treatment Regimens for Helicobacter Pylori Infection.
An observational study of Helicobacter Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Clarithromycin (CLA)、amoxicillin (AMO)、metronidazole (MET)、levofloxacin (LEV) and tetracycline (TET) are commonly used antibiotics for Helicobacter pylori (Hp) therapy. However, the efficacy of treatment for Helicobacter pylori infection has decreased due to increasing resistance to CLA, MET and LEV. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole
- How many people
- 1,821 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2018to 31 Dec 2018
- Phase
- Observational
- 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
Study population: Medical Center
Who may be able to join
- patients (aged ≥ 20 years old) with H. pylori infection between Jan. 1994 to Mar. 2018
Who cannot join
- without antibiotics susceptible test result, without treatment outcome, history of any gastrointestinal surgery, serious concomitant (renal failure, liver cirrhosis, heart failure and disease need immunosuppressant for therapy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tzu-Chi Lai
Taipei, No.33, Linsen S. Rd., Zhongzheng Dist, 100
Tzu-Chi Lai, Master
About this study
Clarithromycin (CLA)、amoxicillin (AMO)、metronidazole (MET)、levofloxacin (LEV) and tetracycline (TET) are commonly used antibiotics for Helicobacter pylori (Hp) therapy. However, the efficacy of treatment for Helicobacter pylori infection has decreased due to increasing resistance to CLA, MET and LEV. Studies had reported that beside antibiotics resistance, other factors such as age, sex, underlying disease, etc. may also affect the treatment efficacy. In some cases, when the MIC values were beyond the breakpoint, H. pylori strains with lower MIC value had better eradication than the ones with higher MIC value. However, few study investigated the relationship between MIC values and treatment outcome.
The investigators aimed to analyze the impact of influencing factors, especially minimal inhibitory concentration (MIC) value, on the efficacy of different treatment regimens.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole
- Keywords
- Helicobacter pylori, Resistance, Minimal inhibitory concentration, Treatment efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton pump inhibitor,clarithromycin,amoxicillin or metronidazoleDrug
Triple or quadruple therapy consist of Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole.
| Study group | Role | What they receive |
|---|---|---|
| CLA triple therapy | Patients with clarithromycin-containing triple therapy Receives: Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole | |
| MET triple therapy | Patients with metronidazole-containing triple therapy Receives: Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole | |
| Concomitant therapy | Patients with concomitant therapy Receives: Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole | |
| Sequential therapy | Patients with sequential therapy Receives: Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between eradication rate (%) of therapy regimen and influencing factors (eg. sex, age, diagnosis, MIC).
Measured: 4 weeks after treatment finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start1 Apr 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,821 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583476
- Sponsor's protocol ID
- 201804076RIND
- Status last verified
- Jun 2018
- First submitted
- 22 Jun 2018
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Antibiotics MIC Value on the Efficacy of Treatment Regimens for Helicobacter Pylori Infection.
- ClinicalTrials.gov ID
- NCT03583476
- Acronym / sponsor ID
- 201804076RIND
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Resistance, Minimal inhibitory concentration, Treatment efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,821 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 11 Jul 2018 (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.
Clarithromycin (CLA)、amoxicillin (AMO)、metronidazole (MET)、levofloxacin (LEV) and tetracycline (TET) are commonly used antibiotics for Helicobacter pylori (Hp) therapy. However, the efficacy of treatment for Helicobacter pylori infection has decreased due to increasing resistance to CLA, MET and LEV. Studies had reported that beside antibiotics resistance, other factors such as age, sex, underlying disease, etc. may also affect the treatment efficacy. In some cases, when the MIC values were beyond the breakpoint, H. pylori strains with lower MIC value had better eradication than the ones with higher MIC value. However, few study investigated the relationship between MIC values and treatment outcome.
The investigators aimed to analyze the impact of influencing factors, especially minimal inhibitory concentration (MIC) value, on the efficacy of different treatment regimens.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CLA triple therapy | – | Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazolePatients with clarithromycin-containing triple therapy |
| MET triple therapy | – | Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazolePatients with metronidazole-containing triple therapy |
| Concomitant therapy | – | Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazolePatients with concomitant therapy |
| Sequential therapy | – | Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazolePatients with sequential therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical Center
Key inclusion criteria (1 listed)
- patients (aged ≥ 20 years old) with H. pylori infection between Jan. 1994 to Mar. 2018
Key exclusion criteria (1 listed)
- without antibiotics susceptible test result, without treatment outcome, history of any gastrointestinal surgery, serious concomitant (renal failure, liver cirrhosis, heart failure and disease need immunosuppressant for therapy.
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 |
|---|---|---|
| Proton pump inhibitor,clarithromycin,amoxicillin or metronidazoleTriple or quadruple therapy consist of Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole. | Drug | CLA triple therapy, Concomitant therapy, MET triple therapy, Sequential therapy |
Primary outcome
Relationship between eradication rate (%) of therapy regimen and influencing factors (eg. sex, age, diagnosis, MIC).
Time frame: 4 weeks after treatment finished.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: No
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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?
An observational study of Helicobacter Pylori Infection, run by National Taiwan University 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 1 inclusion and 1 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 11 Jul 2018. 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 Tzu-Chi Lai, Master (886233668791, b01403056@g.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between eradication rate (%) of therapy regimen and influencing factors (eg. sex, age, diagnosis, MIC). (time frame: 4 weeks after treatment finished.). 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 11 Jul 2018.