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Comparison Between Quadruple Regimens for Helicobacter Pylori Infection in Egypt

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ClinicalTrials.gov Identifier: NCT04039412
Recruitment Status : Completed
First Posted : July 31, 2019
Results First Posted : November 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman Magd Eldin Mohammad Sadek, Zagazig University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Helicobacter Pylori Infection
Interventions Drug: Hybrid regimen
Drug: Reverse hybrid regimen
Drug: Levofloxacin quadruple regimen
Enrollment 330
Recruitment Details We conducted an interventional randomized trial at the internal medicine department clinic, Zagazig University Hospital, Zagazig, Egypt, in the period from July 2018 to June 2019. We allocated the participants attending the clinic by simple randomization over the three treatment groups.
Pre-assignment Details  
Arm/Group Title (1) Reverse Hybrid Regimen (2) Hybrid Regimen (3) Levofloxacin Quadruple Regimen
Hide Arm/Group Description

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.

Reverse hybrid regimen: one-step two-phase (quadruple-dual) treatment

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.

Hybrid regimen: two-step (dual-quadruple) treatment

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

Levofloxacin quadruple regimen: non-Clarithromycin non-Bismuth quadruple therapy

Period Title: Overall Study
Started 110 110 110
Completed 109 107 108
Not Completed 1 3 2
Arm/Group Title (1) Reverse Hybrid Regimen (2) Hybrid Regimen (3) Levofloxacin Quadruple Regimen Total
Hide Arm/Group Description

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.

Reverse hybrid regimen: one-step two-phase (quadruple-dual) treatment

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.

Hybrid regimen: two-step (dual-quadruple) treatment

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

Levofloxacin quadruple regimen: non-Clarithromycin non-Bismuth quadruple therapy

Total of all reporting groups
Overall Number of Baseline Participants 110 110 110 330
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 110 participants 110 participants 330 participants
32.05  (9.772) 32.31  (9.409) 32.44  (9.713) 32.27  (9.604)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 110 participants 110 participants 330 participants
Female
57
  51.8%
58
  52.7%
55
  50.0%
170
  51.5%
Male
53
  48.2%
52
  47.3%
55
  50.0%
160
  48.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Egypt Number Analyzed 110 participants 110 participants 110 participants 330 participants
110 110 110 330
1.Primary Outcome
Title Percentage of Helicobacter Pylori Infection Cure
Hide Description Measuring the curative rate of each regimen by a fecal antigen test
Time Frame 40-44 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title (1) Reverse Hybrid Regimen (2) Hybrid Regimen (3) Levofloxacin Quadruple Regimen
Hide Arm/Group Description:
clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid for 1 week, followed by omeprazole 20 mg bid, and amoxicillin 1gm bid in the 2nd week
omeprazole 20 mg bid, and amoxicillin 1gm bid in the 1st week, then clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid in the 2nd week
levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days
Overall Number of Participants Analyzed 110 110 110
Measure Type: Count of Participants
Unit of Measure: Participants
102
  92.7%
101
  91.8%
91
  82.7%
2.Primary Outcome
Title Incidence of Treatment-Emergent Adverse Events
Hide Description Questionnaire to measure the number of Participants with Treatment-Emergent Adverse Events
Time Frame 10-14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title (1) Reverse Hybrid Regimen (2) Hybrid Regimen (3) Levofloxacin Quadruple Regimen
Hide Arm/Group Description:
clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid for 1 week, followed by omeprazole 20 mg bid, and amoxicillin 1gm bid in the 2nd week
omeprazole 20 mg bid, and amoxicillin 1gm bid in the 1st week, then clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid in the 2nd week
levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days
Overall Number of Participants Analyzed 110 110 110
Measure Type: Count of Participants
Unit of Measure: Participants
49
  44.5%
58
  52.7%
44
  40.0%
3.Secondary Outcome
Title Rate of Helicobacter Pylori Treatment Completion
Hide Description Questionnaire to evaluate the compliance with each treatment regimen
Time Frame 10-14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title (1) Reverse Hybrid Regimen (2) Hybrid Regimen (3) Levofloxacin Quadruple Regimen
Hide Arm/Group Description:
109 participants in per-protocol analysis (99.1%)
107 participants in per-protocol analysis (97.3%)
108 participants in per-protocol analysis (98.2%)
Overall Number of Participants Analyzed 110 110 110
Measure Type: Count of Participants
Unit of Measure: Participants
109
  99.1%
107
  97.3%
108
  98.2%
Time Frame We followed up the occurrence of adverse events after one week of therapy, at the end of treatment, and Up to 45 days.
Adverse Event Reporting Description We divided the severity of adverse event according to the extent of daily activities limitation, into mild, moderate, and severe (no limitation, partial limitation, and profound limitation respectively).
 
Arm/Group Title (1) Reverse Hybrid Regimen (2) Hybrid Regimen (3) Levofloxacin Quadruple Regimen
Hide Arm/Group Description clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid for 1 week, followed by omeprazole 20 mg bid, and amoxicillin 1gm bid in the 2nd week omeprazole 20 mg bid, and amoxicillin 1gm bid in the 1st week, then clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500mg tid in the 2nd week levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days
All-Cause Mortality
(1) Reverse Hybrid Regimen (2) Hybrid Regimen (3) Levofloxacin Quadruple Regimen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/109 (0.00%)      0/107 (0.00%)      0/108 (0.00%)    
Hide Serious Adverse Events
(1) Reverse Hybrid Regimen (2) Hybrid Regimen (3) Levofloxacin Quadruple Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/109 (0.00%)      0/107 (0.00%)      0/108 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
(1) Reverse Hybrid Regimen (2) Hybrid Regimen (3) Levofloxacin Quadruple Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/110 (44.55%)      58/110 (52.73%)      44/110 (40.00%)    
Gastrointestinal disorders       
Gastrointestinal symptoms   41/110 (37.27%)  41 50/110 (45.45%)  50 37/110 (33.64%)  37
General disorders       
General symptoms   8/110 (7.27%)  8 8/110 (7.27%)  8 7/110 (6.36%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ayman Fathy Elsayed
Organization: Zagazig University-Faculty of Human Medicine
Phone: +201125020593
EMail: aymanf28@yahoo.com
Publications:
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.
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.
Layout table for additonal information
Responsible Party: Ayman Magd Eldin Mohammad Sadek, Zagazig University
ClinicalTrials.gov Identifier: NCT04039412    
Other Study ID Numbers: ZU-IRB#5089
First Submitted: July 4, 2019
First Posted: July 31, 2019
Results First Submitted: September 22, 2019
Results First Posted: November 26, 2019
Last Update Posted: November 26, 2019