Helicobacter Pylori InfectionNCT02547012

Comparison of Two Rescue Therapies for Helicobacter Pylori Infection

A study testing esomeprazole+amox+levo+tetra and esomeprazole+amox+levo in people with Helicobacter Pylori Infection, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment. Read more about this study

Who is it for?: Ages 20 to 90 years
Conditions the study is for: Helicobacter Pylori Infection
What is being tested?: esomeprazole+amox+levo+tetra and esomeprazole+amox+levo
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteTaiwan
Study dates: Nov 2013to Oct 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

positive results of both rapid urease test and histology,
a positive result of urea breath test,
or a positive result of culture.

Who cannot join

ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）within the prior 4 weeks,
patients with allergic history to the medications used,
patients with previous gastric surgery,
the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
pregnant women

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Kaohsiung Veterans General Hospital
Kaohsiung City, 813

Other trials in Taiwan

About this study

Official title: Comparison of Two Rescue Therapies for Helicobacter Pylori Infection - A Multicenter Randomized Controlled Trial

From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

Read the detailed description

The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either EALT (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.) therapy or EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

Conditions: Helicobacter Pylori Infection
Being tested: esomeprazole+amox+levo+tetra, esomeprazole+amox+levo
Keywords: Helicobacter pylori, Eradication rate, Rescue treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

esomeprazole+amox+levo+tetraDrug
Also called esomeprazole 40mg, amoxicillin 500 mg, levofloxacin 500 mg, tetracycline 500 mg
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
esomeprazole+amox+levoDrug
Also called esomeprazole 40 mg, amoxicillin 500 mg, levofloxacin 500 mg
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,

Study groups in NCT02547012
Study group	Role	What they receive
esomeprazole+amox+levo+tetra	Experimental	esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s. Receives: Drug: esomeprazole+amox+levo+tetra
esomeprazole+amox+levo	Active comparator	esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d. Receives: Drug: esomeprazole+amox+levo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants in Which H. Pylori Was Eradicated
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Measured: six weeks after the end of anti-H pylori therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Oct 2017

First posted11 Sep 2015 (estimated)
Study startNov 2013
Primary completionJul 2017
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (31)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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02547012
Sponsor's protocol ID: VGHKS13-CT11-15
Status last verified: Mar 2019
First submitted: 6 Sep 2015
Last updated: 14 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Suerbaum S, Michetti P. Helicobacter pylori infection. N Engl J Med. 2002 Oct 10;347(15):1175-86. doi: 10.1056/NEJMra020542. No abstract available.
PubMed 12374879
Malfertheiner P, Chan FK, McColl KE. Peptic ulcer disease. Lancet. 2009 Oct 24;374(9699):1449-61. doi: 10.1016/S0140-6736(09)60938-7. Epub 2009 Aug 13.
PubMed 19683340
Sung JJ, Chung SC, Ling TK, Yung MY, Leung VK, Ng EK, Li MK, Cheng AF, Li AK. Antibacterial treatment of gastric ulcers associated with Helicobacter pylori. N Engl J Med. 1995 Jan 19;332(3):139-42. doi: 10.1056/NEJM199501193320302.
PubMed 7800005
Zucca E, Dreyling M; ESMO Guidelines Working Group. Gastric marginal zone lymphoma of MALT type: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2009 May;20 Suppl 4:113-4. doi: 10.1093/annonc/mdp146. No abstract available.
PubMed 19454427
Asaka M, Kato M, Takahashi S, Fukuda Y, Sugiyama T, Ota H, Uemura N, Murakami K, Satoh K, Sugano K; Japanese Society for Helicobacter Research. Guidelines for the management of Helicobacter pylori infection in Japan: 2009 revised edition. Helicobacter. 2010 Feb;15(1):1-20. doi: 10.1111/j.1523-5378.2009.00738.x.
PubMed 20302585
Malfertheiner P, Megraud F, O'Morain C, Bazzoli F, El-Omar E, Graham D, Hunt R, Rokkas T, Vakil N, Kuipers EJ. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut. 2007 Jun;56(6):772-81. doi: 10.1136/gut.2006.101634. Epub 2006 Dec 14.
PubMed 17170018
Fock KM, Katelaris P, Sugano K, Ang TL, Hunt R, Talley NJ, Lam SK, Xiao SD, Tan HJ, Wu CY, Jung HC, Hoang BH, Kachintorn U, Goh KL, Chiba T, Rani AA; Second Asia-Pacific Conference. Second Asia-Pacific Consensus Guidelines for Helicobacter pylori infection. J Gastroenterol Hepatol. 2009 Oct;24(10):1587-600. doi: 10.1111/j.1440-1746.2009.05982.x.
PubMed 19788600
Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4.
PubMed 20525969
Gumurdulu Y, Serin E, Ozer B, Kayaselcuk F, Ozsahin K, Cosar AM, Gursoy M, Gur G, Yilmaz U, Boyacioglu S. Low eradication rate of Helicobacter pylori with triple 7-14 days and quadriple therapy in Turkey. World J Gastroenterol. 2004 Mar 1;10(5):668-71. doi: 10.3748/wjg.v10.i5.668.
PubMed 14991935
Bigard MA, Delchier JC, Riachi G, Thibault P, Barthelemy P. One-week triple therapy using omeprazole, amoxycillin and clarithromycin for the eradication of Helicobacter pylori in patients with non-ulcer dyspepsia: influence of dosage of omeprazole and clarithromycin. Aliment Pharmacol Ther. 1998 Apr;12(4):383-8. doi: 10.1046/j.1365-2036.1998.00315.x.
PubMed 9690730
Gatta L, Vakil N, Leandro G, Di Mario F, Vaira D. Sequential therapy or triple therapy for Helicobacter pylori infection: systematic review and meta-analysis of randomized controlled trials in adults and children. Am J Gastroenterol. 2009 Dec;104(12):3069-79; quiz 1080. doi: 10.1038/ajg.2009.555. Epub 2009 Oct 20.
PubMed 19844205
Chuah SK, Tsay FW, Hsu PI, Wu DC. A new look at anti-Helicobacter pylori therapy. World J Gastroenterol. 2011 Sep 21;17(35):3971-5. doi: 10.3748/wjg.v17.i35.3971.
PubMed 22046084
Wu DC, Hsu PI, Wu JY, Opekun AR, Kuo CH, Wu IC, Wang SS, Chen A, Hung WC, Graham DY. Sequential and concomitant therapy with four drugs is equally effective for eradication of H pylori infection. Clin Gastroenterol Hepatol. 2010 Jan;8(1):36-41.e1. doi: 10.1016/j.cgh.2009.09.030. Epub 2009 Oct 3.
PubMed 19804842
Hsu PI, Wu DC, Wu JY, Graham DY. Modified sequential Helicobacter pylori therapy: proton pump inhibitor and amoxicillin for 14 days with clarithromycin and metronidazole added as a quadruple (hybrid) therapy for the final 7 days. Helicobacter. 2011 Apr;16(2):139-45. doi: 10.1111/j.1523-5378.2011.00828.x.
PubMed 21435092
Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.
PubMed 22491499

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Helicobacter Pylori Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Two Rescue Therapies for Helicobacter Pylori Infection - A Multicenter Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02547012
Acronym / sponsor ID: VGHKS13-CT11-15
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori, Eradication rate, Rescue treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Kaohsiung Veterans General Hospital.University, hospital or other
Collaborators: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study start: Nov 2013
Primary completion: Jul 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 11 Sep 2015 (estimated)
Results: Posted 14 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
esomeprazole+amox+levo+tetra	Experimental	Drug: esomeprazole+amox+levo+tetraesomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
esomeprazole+amox+levo	Active comparator	Drug: esomeprazole+amox+levoesomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.

Who may qualify

Ages: 20 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

positive results of both rapid urease test and histology,
a positive result of urea breath test,
or a positive result of culture.

Key exclusion criteria (5 listed)

ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）within the prior 4 weeks,
patients with allergic history to the medications used,
patients with previous gastric surgery,
the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
pregnant women

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
esomeprazole+amox+levo+tetraAlso: esomeprazole 40mg, amoxicillin 500 mg, levofloxacin 500 mg, tetracycline 500 mgesomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.	Drug	esomeprazole+amox+levo+tetra
esomeprazole+amox+levoAlso: esomeprazole 40 mg, amoxicillin 500 mg, levofloxacin 500 mgesomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,	Drug	esomeprazole+amox+levo

Primary outcome

Number of Participants in Which H. Pylori Was Eradicated
Time frame: six weeks after the end of anti-H pylori therapy.
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

Results and safety

Results posted to the registry on 14 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Esomeprazole+Amox+Levo+Tetra	24	24
Esomeprazole+Amox+Levo	27	27

Primary outcome: Number of Participants in Which H. Pylori Was Eradicated

Time frame: six weeks after the end of anti-H pylori therapy.. Number. Unit: participants

Measure	Esomeprazole+Amox+Levo+Tetra n = 24	Esomeprazole+Amox+Levo n = 27
Value	13	21

Population analysed: Intention to treat

Adverse events

Time frame: 2 months. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esomeprazole+Amox+Levo+Tetra	0 of 24 (0%)	14 of 24 (58.3%)	0 of 24
Esomeprazole+Amox+Levo	0 of 27 (0%)	5 of 27 (18.5%)	0 of 27

Limitations and caveats (from the sponsor): The trial was performed in a single country

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12374879Suerbaum S, Michetti P. Helicobacter pylori infection. N Engl J Med. 2002 Oct 10;347(15):1175-86. doi: 10.1056/NEJMra020542. No abstract available.
Background: PubMed 19683340Malfertheiner P, Chan FK, McColl KE. Peptic ulcer disease. Lancet. 2009 Oct 24;374(9699):1449-61. doi: 10.1016/S0140-6736(09)60938-7. Epub 2009 Aug 13.
Background: PubMed 7800005Sung JJ, Chung SC, Ling TK, Yung MY, Leung VK, Ng EK, Li MK, Cheng AF, Li AK. Antibacterial treatment of gastric ulcers associated with Helicobacter pylori. N Engl J Med. 1995 Jan 19;332(3):139-42. doi: 10.1056/NEJM199501193320302.
Background: PubMed 19454427Zucca E, Dreyling M; ESMO Guidelines Working Group. Gastric marginal zone lymphoma of MALT type: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2009 May;20 Suppl 4:113-4. doi: 10.1093/annonc/mdp146. No abstract available.
Background: PubMed 20302585Asaka M, Kato M, Takahashi S, Fukuda Y, Sugiyama T, Ota H, Uemura N, Murakami K, Satoh K, Sugano K; Japanese Society for Helicobacter Research. Guidelines for the management of Helicobacter pylori infection in Japan: 2009 revised edition. Helicobacter. 2010 Feb;15(1):1-20. doi: 10.1111/j.1523-5378.2009.00738.x.
Background: PubMed 17170018Malfertheiner P, Megraud F, O'Morain C, Bazzoli F, El-Omar E, Graham D, Hunt R, Rokkas T, Vakil N, Kuipers EJ. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut. 2007 Jun;56(6):772-81. doi: 10.1136/gut.2006.101634. Epub 2006 Dec 14.
Background: PubMed 19788600Fock KM, Katelaris P, Sugano K, Ang TL, Hunt R, Talley NJ, Lam SK, Xiao SD, Tan HJ, Wu CY, Jung HC, Hoang BH, Kachintorn U, Goh KL, Chiba T, Rani AA; Second Asia-Pacific Conference. Second Asia-Pacific Consensus Guidelines for Helicobacter pylori infection. J Gastroenterol Hepatol. 2009 Oct;24(10):1587-600. doi: 10.1111/j.1440-1746.2009.05982.x.
Background: PubMed 20525969Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4.
Background: PubMed 14991935Gumurdulu Y, Serin E, Ozer B, Kayaselcuk F, Ozsahin K, Cosar AM, Gursoy M, Gur G, Yilmaz U, Boyacioglu S. Low eradication rate of Helicobacter pylori with triple 7-14 days and quadriple therapy in Turkey. World J Gastroenterol. 2004 Mar 1;10(5):668-71. doi: 10.3748/wjg.v10.i5.668.
Background: PubMed 9690730Bigard MA, Delchier JC, Riachi G, Thibault P, Barthelemy P. One-week triple therapy using omeprazole, amoxycillin and clarithromycin for the eradication of Helicobacter pylori in patients with non-ulcer dyspepsia: influence of dosage of omeprazole and clarithromycin. Aliment Pharmacol Ther. 1998 Apr;12(4):383-8. doi: 10.1046/j.1365-2036.1998.00315.x.
Background: PubMed 19844205Gatta L, Vakil N, Leandro G, Di Mario F, Vaira D. Sequential therapy or triple therapy for Helicobacter pylori infection: systematic review and meta-analysis of randomized controlled trials in adults and children. Am J Gastroenterol. 2009 Dec;104(12):3069-79; quiz 1080. doi: 10.1038/ajg.2009.555. Epub 2009 Oct 20.
Background: PubMed 22046084Chuah SK, Tsay FW, Hsu PI, Wu DC. A new look at anti-Helicobacter pylori therapy. World J Gastroenterol. 2011 Sep 21;17(35):3971-5. doi: 10.3748/wjg.v17.i35.3971.

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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.

Ping-I Hsu, Bachelor study chair

Kaohsiung Veterans General Hospital.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing esomeprazole+amox+levo+tetra and esomeprazole+amox+levo in people with Helicobacter Pylori Infection, run by Kaohsiung Veterans General 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 5 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 14 Mar 2019. 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?

Yes. Results are posted in the registry (first posted 14 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants in Which H. Pylori Was Eradicated (time frame: six weeks after the end of anti-H pylori therapy.). 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 NCT02547012, which also lists 31 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 14 Mar 2019.