Comparison Between Quadruple Regimens for Helicobacter Pylori Infection in Egypt

NCT04039412 | Completed Phase 4 Results DMC

• 1 other identifier: ZU-IRB#5089
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

The overall prevalence of H. Pylori in the developing countries is 50.8%, with the highest one presented in Africa (79.1%). Hybrid therapy is supposed to be more effective as a first-line regimen for Helicobacter pylori infection in Egypt than the Reverse hybrid and non-bismuth Levofloxacin quadruple therapies. We are aiming here to compare the Hybrid, Reverse hybrid, and Levofloxacin quadruple therapies as first-line therapy, trying to reach the safest, cost-effective, and compliance-inducing regimen in Egypt. We will conduct a randomized controlled (interventional) study at Zagazig University Hospital, internal medicine department clinic, on 330 patients. 110 patients will be allocated to each regimen.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori Infection; Quadruple Therapy; Egypt

Outcome Measures

Primary Outcomes (2)

• Percentage of Helicobacter Pylori Infection Cure

  Measuring the curative rate of each regimen by a fecal antigen test

  40-44 days

• Incidence of Treatment-Emergent Adverse Events

  Questionnaire to measure the number of Participants with Treatment-Emergent Adverse Events

  10-14 days

Secondary Outcomes (1)

• Rate of Helicobacter Pylori Treatment Completion

  10-14 days

Study Arms (3)

(1) Hybrid regimen

ACTIVE COMPARATOR

omeprazole 20mg bid, and amoxicillin 1gm bid in the 1st week, then clarithromycin 500mg bid, omeprazole 20mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid in the 2nd week.

Drug: Hybrid regimen

(2) Reverse hybrid regimen

ACTIVE COMPARATOR

clarithromycin 500mg bid, omeprazole 20mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid for 1 week, followed by omeprazole 20mg bid, and amoxicillin 1gm bid in the 2nd week.

Drug: Reverse hybrid regimen

(3) Levofloxacin quadruple regimen

ACTIVE COMPARATOR

levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days. (LOAD)

Drug: Levofloxacin quadruple regimen

Interventions

Hybrid regimen DRUG

two-step (dual-quadruple) treatment

(1) Hybrid regimen

Reverse hybrid regimen DRUG

one-step two-phase (quadruple-dual) treatment

(2) Reverse hybrid regimen

Levofloxacin quadruple regimen DRUG

non-Clarithromycin non-Bismuth quadruple therapy

(3) Levofloxacin quadruple regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive Helicobacter pylori antigen in the stool
• Treatment-naive

You may not qualify if:

• Previous treatment for Helicobacter pylori
• Drug hypersensitivity

Sponsors & Collaborators

• Ayman Magd Eldin Mohammad Sadek: lead

Study Sites (1)

Faculty of Human Medicine, Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (16)

• Torres J, Perez-Perez G, Goodman KJ, Atherton JC, Gold BD, Harris PR, la Garza AM, Guarner J, Munoz O. A comprehensive review of the natural history of Helicobacter pylori infection in children. Arch Med Res. 2000 Sep-Oct;31(5):431-69. doi: 10.1016/s0188-4409(00)00099-0.

  PMID: 11179581 BACKGROUND

• Zamani M, Ebrahimtabar F, Zamani V, Miller WH, Alizadeh-Navaei R, Shokri-Shirvani J, Derakhshan MH. Systematic review with meta-analysis: the worldwide prevalence of Helicobacter pylori infection. Aliment Pharmacol Ther. 2018 Apr;47(7):868-876. doi: 10.1111/apt.14561. Epub 2018 Feb 12.

  PMID: 29430669 BACKGROUND

• Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27.

  PMID: 28456631 BACKGROUND

• El Dine SS, Mubarak M, Salama R, El Raziky M, El Sherbiny E, Zakaria S, Zakaria MS. Low Seroprevalence of anti-CagA antibodies inspite of high seroprevalence of anti-H. Pylori antibodies in rural Egyptian community. Research Journal of Medicine and Medical Sciences. 2008; 3(2):118-23.

  BACKGROUND

• Diab M, El-Dine SS, Aboul-Fadl L, Shemis M, Omran Z, Badawi A, El-Ghannam M, El-Ray A, Fam N, El-Defrawy I, El-Sherbini E. Helicobacterpylori cag pathogenicity island genes among dyspeptic patients with chronic gastritis. Egypt J Med Microbiol. 2009; 18:43-53.

  BACKGROUND

• 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.

  PMID: 12374879 BACKGROUND

• Garza-Gonzalez E, Perez-Perez GI, Maldonado-Garza HJ, Bosques-Padilla FJ. A review of Helicobacter pylori diagnosis, treatment, and methods to detect eradication. World J Gastroenterol. 2014 Feb 14;20(6):1438-49. doi: 10.3748/wjg.v20.i6.1438.

  PMID: 24587620 BACKGROUND

• Huang YK, Wu MC, Wang SS, Kuo CH, Lee YC, Chang LL, Wang TH, Chen YH, Wang WM, Wu DC, Kuo FC. Lansoprazole-based sequential and concomitant therapy for the first-line Helicobacter pylori eradication. J Dig Dis. 2012 Apr;13(4):232-8. doi: 10.1111/j.1751-2980.2012.00575.x.

  PMID: 22435509 BACKGROUND

• 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.

  PMID: 22491499 BACKGROUND

• Georgopoulos SD, Papastergiou V, Karatapanis S. Helicobacter pylori Eradication Therapies in the Era of Increasing Antibiotic Resistance: A Paradigm Shift to Improved Efficacy. Gastroenterol Res Pract. 2012;2012:757926. doi: 10.1155/2012/757926. Epub 2012 Jun 19.

  PMID: 22778723 BACKGROUND

• Liou JM, Fang YJ, Chen CC, Bair MJ, Chang CY, Lee YC, Chen MJ, Chen CC, Tseng CH, Hsu YC, Lee JY, Yang TH, Luo JC, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hu WH, Chen YN, Sheu BS, Lin JT, Wu JY, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Concomitant, bismuth quadruple, and 14-day triple therapy in the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2016 Nov 12;388(10058):2355-2365. doi: 10.1016/S0140-6736(16)31409-X. Epub 2016 Oct 18.

  PMID: 27769562 BACKGROUND

• Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.

  PMID: 27707777 BACKGROUND

• Liatsos C, Georgopoulos SD. Helicobacter pylori best treatment approach: should a national consensus be the best consensus? Ann Gastroenterol. 2017;30(6):704-706. doi: 10.20524/aog.2017.0183. Epub 2017 Aug 2. No abstract available.

  PMID: 29118570 BACKGROUND

• Hsu PI, Tsay FW, Graham DY, Tsai TJ, Tsai KW, Kao JY, Peng NJ, Kuo CH, Kao SS, Wang HM, Lin TF, Wu DC; Taiwan Acid-related Disease (TARD) Study Group. Equivalent Efficacies of Reverse Hybrid and Bismuth Quadruple Therapies in Eradication of Helicobacter pylori Infection in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2018 Sep;16(9):1427-1433. doi: 10.1016/j.cgh.2018.03.031. Epub 2018 Mar 31.

  PMID: 29609070 BACKGROUND

• Basu PP, Rayapudi K, Pacana T, Shah NJ, Krishnaswamy N, Flynn M. A randomized study comparing levofloxacin, omeprazole, nitazoxanide, and doxycycline versus triple therapy for the eradication of Helicobacter pylori. Am J Gastroenterol. 2011 Nov;106(11):1970-5. doi: 10.1038/ajg.2011.306. Epub 2011 Oct 11.

  PMID: 21989146 BACKGROUND

• Abd-Elsalam S, Kobtan A, El-Kalla F, Elkhalawany W, Nawasany SE, Saif SA, Yousef M, Ali LA, Soliman S, Mansour L, Habba E, Soliman H, Rizk F, Shehata MA. A 2-week Nitazoxanide-based quadruple treatment as a rescue therapy for Helicobacter pylori eradication: A single center experience. Medicine (Baltimore). 2016 Jun;95(24):e3879. doi: 10.1097/MD.0000000000003879.

  PMID: 27310977 BACKGROUND

Results Point of Contact

• Title: Dr. Ayman Fathy Elsayed
• Organization: Zagazig University-Faculty of Human Medicine

aymanf28@yahoo.com

+201125020593

Study Officials

• Ayman MM Sadek, MD

  Zagazig University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This is a randomized controlled (interventional) study conducted at Zagazig University Hospital, internal medicine department clinic

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 31, 2019
• Study Start: June 1, 2018
• Primary Completion: December 22, 2018
• Study Completion: June 30, 2019
• Last Updated: November 26, 2019
• Results First Posted: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study publication

Locations

EG (1)