Helicobacter Pylori InfectionNCT01486082
Antimicrobial Susceptibility for Helicobacter Pylori Eradication
An observational study of Helicobacter Pylori Infection, run by Hospital Donostia at 1 site in Spain.
Trial summary
Due to the high rate of resistance to clarithromycin in our area the investigators proposed an study to assess the need of antibiogram previous to the empirical OCA 10 treatment, in order to improve the rate of eradication. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- OCA 10
- How many people
- 1 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2011to May 2012
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators recruited patients who are diagnosed with helicobacter pylori infection in our hospital (Hospital Donostia) or in any of the specialist care centres under the management of the Hospital Donostia.
Who may be able to join
- Diagnosis of H. pylori infection provided by culture, histology or UBT.
- Patients need and indication to treat (peptic ulcer disease, firs-degree family history of gastric cancer, MALT lymphoma or dyspeptic symptoms)
- Patients must be 18 years or older.
Who cannot join
- Previous treatment for H. pylori eradication.
- Patients who have severe concomitant disease.
- Patients who have previous gastric surgery.
- Patients who have intolerance to any antimicrobial drugs.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Donostia
Donostia / San Sebastian, Guipuzcoa, 20014
LUIS BUJANDA, Dr, 943 007173, luis.bujandafernandezdepierola@osakidetza.net
MAIDER MARTOS, Dr., 943 00 7173, maider.martosmartin@osakidetza.net
About this study
Official title: Usefulness of Antimicrobial Susceptibility in the Eradication of Helicobacter Pylori
Due to the high rate of resistance to clarithromycin in our area the investigators proposed an study to assess the need of antibiogram previous to the empirical OCA 10 treatment, in order to improve the rate of eradication.
Read the detailed description
Usefulness of antimicrobial susceptibility in the eradication of Helicobacter pylori
PURPOSE
Background:
- The rate of eradication of Helicobacter pylori with standard triple therapy (OCA: omeprazole + clarithromycin + amoxicillin) in our area is less than the expected according to the III Maastricht III consensus. However, the current guidelines recommend the use of this therapy.
- According to the Maastricht III consensus, in populations with high rates of clarithromycin resistance (15-20%) another therapy should be considered, or alternatively, testing antimicrobial susceptibility of the H. pylori prior to treatment.
Objectives:
- To clarify the real rate of eradication with OCA therapy with and without antimicrobial susceptibility in our area (with high rate of resistance to clarythromycin).
- To study which is the diagnostic-therapeutic strategy more cost-effective for the treatment of H. pylori.
Design:
- Participants will be screened with a full medical history.
- Participants will aleatory receive OCA therapy empirically, or after antimicrobial susceptibility test if there is no resistance to clarythromycin, for ten days.
- In all cases the eradication of H. pylori will be checked by 13C urea breath test (UBT) in 8 weeks after the therapy have been finished.
- All the adverse event of the therapy will be reported.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- OCA 10
- Keywords
- OCA 10, Antibiogram, Eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCA 10Other
Also called O: Omeprazole, C: Clarithromycin, A: Amoxicillin
A group will be treated with omeprazole (20 mg / 12 h), amoxicillin (1 g/ 12 h)and clarithromycin (500 mg/12 h) for 10 days (as following current guides) without having a previous antibiogram, and the other group will be treated after antibiotic susceptibility.
| Study group | Role | What they receive |
|---|---|---|
| Empirical OCA | This group will be treated with omeprazole, amoxicillin and clarithromycin without having a previous antibiogram. Receives: Other: OCA 10 | |
| OCA after antibiogram | This group will be treated with omeprazole, clarithromycin and amoxicillin after an antibiotic susceptibility confirmation. Receives: Other: OCA 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in whom Helicobacter pylori was eradicated.
The investigators will measure the rate of eradication in each gruop after OCA treatment. One group receive OCA without antibiogram and the other one after checking the sensitivity to clarithromycin.
Measured: 9 months
Secondary outcomes (2)
Number of patient with adverse event
Measured: 9 months
Cost of the eradication of Helicobacter Pylori in each group.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Donostia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LUIS BUJANDA, Hospital Donostia
- Investigators
- LUIS BUJANDA, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486082
- Sponsor's protocol ID
- HP02
- Status last verified
- Dec 2011
- First submitted
- 19 Nov 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Martos M, Bujanda L, Salicio Y, Sarasqueta C, Ibarra B, Mendarte U, Fernandez-Reyes M, Cosme A. Clarithromycin for first-line treatment of Helicobacter pylori infection after culture in high-resistance regions. Eur J Gastroenterol Hepatol. 2014 Dec;26(12):1380-4. doi: 10.1097/MEG.0000000000000197.
PubMed 25229983
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Antimicrobial Susceptibility in the Eradication of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT01486082
- Acronym / sponsor ID
- HP02
- Conditions
- Helicobacter Pylori Infection
- Keywords
- OCA 10, Antibiogram, Eradication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Hospital DonostiaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- May 2012 (estimated)
- First posted
- 6 Dec 2011 (estimated)
- 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.
Due to the high rate of resistance to clarithromycin in our area the investigators proposed an study to assess the need of antibiogram previous to the empirical OCA 10 treatment, in order to improve the rate of eradication.
Detailed description
Usefulness of antimicrobial susceptibility in the eradication of Helicobacter pylori
PURPOSE
Background:
- The rate of eradication of Helicobacter pylori with standard triple therapy (OCA: omeprazole + clarithromycin + amoxicillin) in our area is less than the expected according to the III Maastricht III consensus. However, the current guidelines recommend the use of this therapy.
- According to the Maastricht III consensus, in populations with high rates of clarithromycin resistance (15-20%) another therapy should be considered, or alternatively, testing antimicrobial susceptibility of the H. pylori prior to treatment.
Objectives:
- To clarify the real rate of eradication with OCA therapy with and without antimicrobial susceptibility in our area (with high rate of resistance to clarythromycin).
- To study which is the diagnostic-therapeutic strategy more cost-effective for the treatment of H. pylori.
Design:
- Participants will be screened with a full medical history.
- Participants will aleatory receive OCA therapy empirically, or after antimicrobial susceptibility test if there is no resistance to clarythromycin, for ten days.
- In all cases the eradication of H. pylori will be checked by 13C urea breath test (UBT) in 8 weeks after the therapy have been finished.
- All the adverse event of the therapy will be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empirical OCA | – | Other: OCA 10This group will be treated with omeprazole, amoxicillin and clarithromycin without having a previous antibiogram. |
| OCA after antibiogram | – | Other: OCA 10This group will be treated with omeprazole, clarithromycin and amoxicillin after an antibiotic susceptibility confirmation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators recruited patients who are diagnosed with helicobacter pylori infection in our hospital (Hospital Donostia) or in any of the specialist care centres under the management of the Hospital Donostia.
Key inclusion criteria (3 listed)
- Diagnosis of H. pylori infection provided by culture, histology or UBT.
- Patients need and indication to treat (peptic ulcer disease, firs-degree family history of gastric cancer, MALT lymphoma or dyspeptic symptoms)
- Patients must be 18 years or older.
Key exclusion criteria (4 listed)
- Previous treatment for H. pylori eradication.
- Patients who have severe concomitant disease.
- Patients who have previous gastric surgery.
- Patients who have intolerance to any antimicrobial 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 |
|---|---|---|
| OCA 10Also: O: Omeprazole, C: Clarithromycin, A: AmoxicillinA group will be treated with omeprazole (20 mg / 12 h), amoxicillin (1 g/ 12 h)and clarithromycin (500 mg/12 h) for 10 days (as following current guides) without having a previous antibiogram, and the other group will be treated after antibiotic susceptibility. | Other | Empirical OCA, OCA after antibiogram |
Primary outcome
Number of patients in whom Helicobacter pylori was eradicated.
Time frame: 9 months
The investigators will measure the rate of eradication in each gruop after OCA treatment. One group receive OCA without antibiogram and the other one after checking the sensitivity to clarithromycin.
2 secondary outcomes
Number of patient with adverse event
Time frame: 9 months
Cost of the eradication of Helicobacter Pylori in each group.
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- Derived from this study: PubMed 25229983Martos M, Bujanda L, Salicio Y, Sarasqueta C, Ibarra B, Mendarte U, Fernandez-Reyes M, Cosme A. Clarithromycin for first-line treatment of Helicobacter pylori infection after culture in high-resistance regions. Eur J Gastroenterol Hepatol. 2014 Dec;26(12):1380-4. doi: 10.1097/MEG.0000000000000197.
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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.
LUIS BUJANDA study director
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 Hospital Donostia at 1 site in Spain.
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 4 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 13 Dec 2011. 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 Spain. 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 LUIS BUJANDA, Dr. (943 00 7173, luis.bujandafernandezdepierola@osakidetza.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients in whom Helicobacter pylori was eradicated. (time frame: 9 months). 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 NCT01486082, which also lists 1 linked publication.
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 13 Dec 2011.