Ignite Creation Date:
2024-05-05 @ 9:07 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00816140
Status:
COMPLETED
Last Update Posted:
2011-04-22
First Post:
2007-08-06
Brief Title:
Levofloxacin Versus Clarithromycin Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Comparative Study of the Levofloxacin-Based and Clarithromycin-Based Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication and Change of Gut Flora and Drug Susceptibility Before and After Treatment
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clarithromycin-based triple therapy containing a proton-pump inhibitor PPI twice daily amoxicillin 1g twice daily and clarithromycin 500 mg twice daily for 7 days is one of the standard firs-line therapy for Helicobacter pylori eradication However because of unsatisfactory eradication rate 80-85 the Maastricht III guideline recommended extending the treatment duration to increase the eradication rate Recently levofloxacin 500 mg qd-based triple therapy has been shown to achieve an eradication rate of 90 for both the first- and second-line treatment for H pylori eradication Several studies have demonstrated that high dose 750mg and short-course 5 days levofloxacin is as effective and well tolerated as traditional dose 500mg and course 10 days for treatment of mild-to-severe community acquired pneumonia The high dose and short-course therapy has the potential to increase patient compliance and reduce bacterial resistance to fluoroquinolones However whether increasing the dosage of levofloxacin from 500mg to 750 mg qd can augment the efficacy of triple therapy in eradication of H pylori and shorten the duration of therapy remains unknown Although levofloxacin-based regimen was presumed to be more effective previous reports pointed the concern that resistance to fluoroquinolone and other antibiotics which susceptible to the pumping efflux of bacteriae would increase among the gut flora
Detailed Description:
Determination of H pylori status Prior to enrollment the status of H pylori infection will be determined by 1 rapid urease test CLO test Kimberly-Clark USA from antrum biopsy 2 histological examination Giemsa stain of antral and body samples two from the antral mucosa and two from the corpus mucosa and 3 culture Positive in any two of the three tests will be defined as positive for H pylori infection After-treatment H pylori status will be determined by 13C-Urea Breath Test 13C-UBT at 6 weeks after the completion of treatment Successful eradication of H pylori is defined as a negative 13C-UBT result
Eradication Therapy Using a computer-generated number sequence patients who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens 1 CALa regimen clarithromycin 500mg twice daily amoxicillin 1000mg twice daily and lansoprazole 30mg twice daily for 7 days or 2 LALa regimen levofloxacin 750mg levofloxacin500 15 tablets once daily amoxicillin 1000mg twice daily lansoprazole 30mg twice daily for 7 days Figure 1 Adverse events will be recorded throughout the trial and during the follow-up period Patients who do not return for 13C-UBT at 6 weeks after completion of treatment will be considered lost-to-follow-up and will be excluded from the per protocol PP analysis
Rescue regimen for treatment failure after first-line regimen Patients who remained positive for H pylori after the initial treatment as determined by the 13C-UBT will be followed by endoscopy Biopsy will be done for H pylori culture and antibiotic susceptibility test All of them will then be treated with rescue regimen The rescue regimens will be given in a cross-over manner Figure 1 Patients who are treated with CALa regimen for 7 days as initial treatment will be treated with LALa regimen for 10 days as rescue treatment Patients who are treated with LALa regimen for 7 days as initial treatment will be treated with CALa regimen for 10 days as rescue treatment
Compliance and Adverse Effect Patients compliance will be assessed by standardized interview at the end of treatment as well as by pill count in the medication boxes returned at the interview Compliance is considered low when more than 20 of pills is found in the box At enrollment the patients will be informed of the common side effects from the studied antibiotics including diarrhea taste disturbance nausea bloating loss of appetite vomiting abdominal pain constipation headache and skin rash
Eradication Therapy Using a computer-generated number sequence patients who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens 1 CALa regimen clarithromycin 500mg twice daily amoxicillin 1000mg twice daily and lansoprazole 30mg twice daily for 7 days or 2 LALa regimen levofloxacin 750mg levofloxacin500 15 tablets once daily amoxicillin 1000mg twice daily lansoprazole 30mg twice daily for 7 days Figure 1 Adverse events will be recorded throughout the trial and during the follow-up period Patients who do not return for 13C-UBT at 6 weeks after completion of treatment will be considered lost-to-follow-up and will be excluded from the per protocol PP analysis
Rescue regimen for treatment failure after first-line regimen Patients who remained positive for H pylori after the initial treatment as determined by the 13C-UBT will be followed by endoscopy Biopsy will be done for H pylori culture and antibiotic susceptibility test All of them will then be treated with rescue regimen The rescue regimens will be given in a cross-over manner Figure 1 Patients who are treated with CALa regimen for 7 days as initial treatment will be treated with LALa regimen for 10 days as rescue treatment Patients who are treated with LALa regimen for 7 days as initial treatment will be treated with CALa regimen for 10 days as rescue treatment
Compliance and Adverse Effect Patients compliance will be assessed by standardized interview at the end of treatment as well as by pill count in the medication boxes returned at the interview Compliance is considered low when more than 20 of pills is found in the box At enrollment the patients will be informed of the common side effects from the studied antibiotics including diarrhea taste disturbance nausea bloating loss of appetite vomiting abdominal pain constipation headache and skin rash
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None