Trial Outcomes & Findings for Comparison Between Quadruple Regimens for Helicobacter Pylori Infection in Egypt (NCT NCT04039412)
NCT ID: NCT04039412
Last Updated: 2019-11-26
Results Overview
Measuring the curative rate of each regimen by a fecal antigen test
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
330 participants
Primary outcome timeframe
40-44 days
Results posted on
2019-11-26
Participant Flow
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.
Participant milestones
| Measure |
(1) Reverse Hybrid Regimen
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
|
(2) Hybrid Regimen
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
|
(3) Levofloxacin Quadruple Regimen
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
110
|
110
|
110
|
|
Overall Study
COMPLETED
|
109
|
107
|
108
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
(1) Reverse Hybrid Regimen
n=110 Participants
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
|
(2) Hybrid Regimen
n=110 Participants
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
|
(3) Levofloxacin Quadruple Regimen
n=110 Participants
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
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.05 years
STANDARD_DEVIATION 9.772 • n=110 Participants
|
32.31 years
STANDARD_DEVIATION 9.409 • n=110 Participants
|
32.44 years
STANDARD_DEVIATION 9.713 • n=110 Participants
|
32.27 years
STANDARD_DEVIATION 9.604 • n=330 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=110 Participants
|
58 Participants
n=110 Participants
|
55 Participants
n=110 Participants
|
170 Participants
n=330 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=110 Participants
|
52 Participants
n=110 Participants
|
55 Participants
n=110 Participants
|
160 Participants
n=330 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Egypt
|
110 participants
n=110 Participants
|
110 participants
n=110 Participants
|
110 participants
n=110 Participants
|
330 participants
n=330 Participants
|
PRIMARY outcome
Timeframe: 40-44 daysMeasuring the curative rate of each regimen by a fecal antigen test
Outcome measures
| Measure |
(1) Reverse Hybrid Regimen
n=110 Participants
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
|
(2) Hybrid Regimen
n=110 Participants
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
|
(3) Levofloxacin Quadruple Regimen
n=110 Participants
levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days
|
|---|---|---|---|
|
Percentage of Helicobacter Pylori Infection Cure
|
102 Participants
|
101 Participants
|
91 Participants
|
PRIMARY outcome
Timeframe: 10-14 daysQuestionnaire to measure the number of Participants with Treatment-Emergent Adverse Events
Outcome measures
| Measure |
(1) Reverse Hybrid Regimen
n=110 Participants
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
|
(2) Hybrid Regimen
n=110 Participants
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
|
(3) Levofloxacin Quadruple Regimen
n=110 Participants
levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days
|
|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
|
49 Participants
|
58 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 10-14 daysQuestionnaire to evaluate the compliance with each treatment regimen
Outcome measures
| Measure |
(1) Reverse Hybrid Regimen
n=110 Participants
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
|
(2) Hybrid Regimen
n=110 Participants
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
|
(3) Levofloxacin Quadruple Regimen
n=110 Participants
levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days
|
|---|---|---|---|
|
Rate of Helicobacter Pylori Treatment Completion
|
109 Participants
|
107 Participants
|
108 Participants
|
Adverse Events
(1) Reverse Hybrid Regimen
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
(2) Hybrid Regimen
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
(3) Levofloxacin Quadruple Regimen
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
(1) Reverse Hybrid Regimen
n=110 participants at risk；n=109 participants at risk
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
|
(2) Hybrid Regimen
n=110 participants at risk；n=107 participants at risk
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
|
(3) Levofloxacin Quadruple Regimen
n=110 participants at risk；n=108 participants at risk
levofloxacin 250mg QD, omeprazole 40mg QD, nitazoxanide 500mg bid, and doxycycline 100mg QD for 10 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
37.3%
41/110 • Number of events 41 • We followed up the occurrence of adverse events after one week of therapy, at the end of treatment, and Up to 45 days.
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).
|
45.5%
50/110 • Number of events 50 • We followed up the occurrence of adverse events after one week of therapy, at the end of treatment, and Up to 45 days.
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).
|
33.6%
37/110 • Number of events 37 • We followed up the occurrence of adverse events after one week of therapy, at the end of treatment, and Up to 45 days.
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).
|
|
General disorders
General symptoms
|
7.3%
8/110 • Number of events 8 • We followed up the occurrence of adverse events after one week of therapy, at the end of treatment, and Up to 45 days.
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).
|
7.3%
8/110 • Number of events 8 • We followed up the occurrence of adverse events after one week of therapy, at the end of treatment, and Up to 45 days.
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).
|
6.4%
7/110 • Number of events 7 • We followed up the occurrence of adverse events after one week of therapy, at the end of treatment, and Up to 45 days.
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).
|
Additional Information
Dr. Ayman Fathy Elsayed
Zagazig University-Faculty of Human Medicine
Phone: +201125020593
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place