Helicobacter Pylori InfectionNCT02978157

Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue Treatment of H Pylori Infection

A study testing esomeprazole+amox+levo and esomeprazole+bismuth+tetra+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 and esomeprazole+bismuth+tetra+levo
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteTaiwan
Study dates: Feb 2015to Sep 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: A Prospective Randomized Trial of Levofloxacin-amoxicillin Triple Therapy vs. Levofloxacin-tetracycline Quadruple Therapy in Second-line Helicobacter Pylori Treatment

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 EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) or EBTL (esomeprazole 40 mg b.d., bismuth 500 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) therapy 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, esomeprazole+bismuth+tetra+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+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.
esomeprazole+bismuth+tetra+levoDrug
Also called esomeprazole 40mg, bismuth 120 mg, tetracycline 500 mg, levofloxacin 500 mg
esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

Study groups in NCT02978157
Study group	Role	What they receive
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
esomeprazole+bismuth+tetra+levo	Experimental	esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d. Receives: Drug: esomeprazole+bismuth+tetra+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
Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication
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.

Feb 2015Sep 2017

First posted30 Nov 2016 (estimated)
Study startFeb 2015
Primary completionSep 2017
Study completionSep 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 (17)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: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02978157
Sponsor's protocol ID: VGHKS104-062
Status last verified: Mar 2019
First submitted: 28 Nov 2016
Last updated: 14 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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
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
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
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
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
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
Hojo M, Miwa H, Nagahara A, Sato N. Pooled analysis on the efficacy of the second-line treatment regimens for Helicobacter pylori infection. Scand J Gastroenterol. 2001 Jul;36(7):690-700. doi: 10.1080/003655201300191941.
PubMed 11444467
Saad RJ, Schoenfeld P, Kim HM, Chey WD. Levofloxacin-based triple therapy versus bismuth-based quadruple therapy for persistent Helicobacter pylori infection: a meta-analysis. Am J Gastroenterol. 2006 Mar;101(3):488-96. doi: 10.1111/j.1572-0241.2006.00637.x.
PubMed 16542284
Pontone S, Standoli M, Angelini R, Pontone P. Efficacy of H. pylori eradication with a sequential regimen followed by rescue therapy in clinical practice. Dig Liver Dis. 2010 Aug;42(8):541-3. doi: 10.1016/j.dld.2009.12.007. Epub 2010 Jan 12.
PubMed 20061196
Gisbert JP, Molina-Infante J, Marin AC, Vinagre G, Barrio J, McNicholl AG. Second-line rescue triple therapy with levofloxacin after failure of non-bismuth quadruple "sequential" or "concomitant" treatment to eradicate H. pylori infection. Scand J Gastroenterol. 2013 Jun;48(6):652-6. doi: 10.3109/00365521.2013.786132. Epub 2013 Apr 5.
PubMed 23556551
Hsu PI, Lai KH, Tseng HH, Liu YC, Yen MY, Lin CK, Lo GH, Huang RL, Huang JS, Cheng JS, Huang WK, Ger LP, Chen W, Hsu PN. Correlation of serum immunoglobulin G Helicobacter pylori antibody titers with histologic and endoscopic findings in patients with dyspepsia. J Clin Gastroenterol. 1997 Dec;25(4):587-91. doi: 10.1097/00004836-199712000-00007.
PubMed 9451668
Peng NJ, Lai KH, Liu RS, Lee SC, Tsay DG, Lo CC, Tseng HH, Huang WK, Lo GH, Hsu PI. Endoscopic 13C-urea breath test for the diagnosis of Helicobacter pylori infection. Dig Liver Dis. 2003 Feb;35(2):73-7. doi: 10.1016/s1590-8658(03)00014-8.
PubMed 12747623

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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Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
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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
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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: A Prospective Randomized Trial of Levofloxacin-amoxicillin Triple Therapy vs. Levofloxacin-tetracycline Quadruple Therapy in Second-line Helicobacter Pylori Treatment
ClinicalTrials.gov ID: NCT02978157
Acronym / sponsor ID: VGHKS104-062
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori, Eradication rate, Rescue treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Kaohsiung Veterans General Hospital.University, hospital or other
Collaborators: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study start: Feb 2015
Primary completion: Sep 2017 (actual)
Study completion: Sep 2017 (actual)
First posted: 30 Nov 2016 (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	Active comparator	Drug: esomeprazole+amox+levoesomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+bismuth+tetra+levo	Experimental	Drug: esomeprazole+bismuth+tetra+levoesomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 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+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
esomeprazole+bismuth+tetra+levoAlso: esomeprazole 40mg, bismuth 120 mg, tetracycline 500 mg, levofloxacin 500 mgesomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.	Drug	esomeprazole+bismuth+tetra+levo

Primary outcome

Number of Participants in Which H. Pylori Was Eradicated
Time frame: six weeks after the end of anti-H pylori therapy.
Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication

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	52	52
Esomeprazole+Bismuth+Tetra+Levo	50	50

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 n = 52	Esomeprazole+Bismuth+Tetra+Levo n = 50
Value	36	49

Esomeprazole+Amox+Levo vs Esomeprazole+Bismuth+Tetra+Levo: p <0.001, Chi-squared

Population analysed: Intention to treat

Adverse events

Time frame: 2 months. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esomeprazole+Amox+Levo	0 of 52 (0%)	6 of 52 (11.5%)	0 of 52
Esomeprazole+Bismuth+Tetra+Levo	0 of 50 (0%)	11 of 50 (22%)	0 of 50

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 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 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 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 19804842Wu 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.
Background: PubMed 22491499Malfertheiner 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.
Background: PubMed 11444467Hojo M, Miwa H, Nagahara A, Sato N. Pooled analysis on the efficacy of the second-line treatment regimens for Helicobacter pylori infection. Scand J Gastroenterol. 2001 Jul;36(7):690-700. doi: 10.1080/003655201300191941.
Background: PubMed 16542284Saad RJ, Schoenfeld P, Kim HM, Chey WD. Levofloxacin-based triple therapy versus bismuth-based quadruple therapy for persistent Helicobacter pylori infection: a meta-analysis. Am J Gastroenterol. 2006 Mar;101(3):488-96. doi: 10.1111/j.1572-0241.2006.00637.x.
Background: PubMed 20061196Pontone S, Standoli M, Angelini R, Pontone P. Efficacy of H. pylori eradication with a sequential regimen followed by rescue therapy in clinical practice. Dig Liver Dis. 2010 Aug;42(8):541-3. doi: 10.1016/j.dld.2009.12.007. Epub 2010 Jan 12.
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.

Ping-I Hsu 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 and esomeprazole+bismuth+tetra+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 NCT02978157, which also lists 17 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.