Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315478
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
Safety and Efficacy of Triple and Quadruple Regimens as First Line Therapy for Management of Helicobacter Pylori Infection in Egyptians
Sponsor:
Helwan University
Organization:
Helwan University
Study Overview
Official Title:
Safety and Efficacy of Triple and Quadruple Regimens as First Line Therapy for Management of Helicobacter Pylori Infection in Egyptians
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Our study aimed to investigate the efficacy and safety of hybrid regimen as a first line therapy for H pylori eradication compared to triple and quadruple regimens in attempt to overcome antibiotic resistance
Detailed Description:
Helicobacter pylori H pylori is a globally prevalent pathogen which infects about over 50 of population However not all cases have clinical symptoms H pylori are described as gram negative bacteria which causes ulcers in the lining of stomach or the upper part of small intestine For some patients a progressive infection can cause gastric cancer which is the second widespread cancer worldwide 1
While this pathogen in Egypt is a public health issue the propagation of H pylori infection is approximately 80 2 study results concluded that H pylori infection in upper Egypt was higher than in urban areas 3
Transmission modes of H pylori are very controversial the reservoir of H pylori is the human stomach The main method of acquisition in both developing and developed countries by fecal oral route whereas the other route of transmission in developed countries is the gastro-oral route mainly water borne prevalence overcrowding of the family of large number members institutionalized children are predisposing for acquiring the infection 46 and occupational risk factor for health members in particular those working in gastrointestinal units 7 Over spread of the infection in upper Egypt could be due to the hygiene level socioeconomic conditions life style and absence of sources of pure water supply in rural areas 3
H pylori has been classified as one of the 12 bacterial species need high priority future strategies for new antibiotic development by the World Health Organization WHO management of H pylori is widely debatable due to high antibiotics resistance prevalence after exclusion of inadequate gastric suppression by proton pump inhibitor and poor adherence to the therapy Furthermore the efficacy of many regimens has declined due to increased antibiotic resistance making H pylori eradication challenging H pylori treatment has been complicated and has required 10 and 14 days of multiple daily doses of three or four different medicines 813
There is no worldwide accepted regimen for the eradication of H pylori infection Standard triple therapy STT with proton pump inhibitors PPI in standard dose clarithromycin 500 mg and amoxicillin 1 g twice daily for 14 days is the standard triple first line regimen in the published international guidelines of the European Helicobacter and Microbiota Study Group in areas of low clarithromycin resistance 14
A randomized controlled trial in Japan showed that clarithromycin resistance is a growing problem found metronidazole to be superior to clarithromycin as a 7-day first-line triple regimen 15
In regions with low dual clarithromycin and metronidazole resistance 15 either a bismuth quadruple therapy BQT PPI bismuth salt tetracycline and metronidazole or non-bismuth concomitant quadruple therapy PPI amoxicillin clarithromycin and metronidazole is recommended 1416 In areas of high dual clarithromycin and metronidazole resistance 15 bismuth quadruple therapy is the recommended regimen However bismuth isnt available in all regions and not preferred due to complexity and the high pill burden 14 pills per day Therefore levofloxacin rifabutin or high dose dual amoxicillin and PPI therapies have been suggested 1417
A levofloxacin triple therapy is recommended as second-line treatment in case of first line therapy failure However clarithromycin-based triple therapy or bismuth quadruple therapy are alternative second-line options if not used as first line regimen and clarithromycin resistance is known to be low
Third-line and subsequent treatment strategies should be guided by antimicrobial susceptibility testing treatment durations of 14 days and the use of newer generation PPIs are recommended in all H pylori regimens unless local evidence suggests that 10 days therapy is efficient 141819 In Egypt the first and second line H pylori regimens as the international guidelines are used to eradicate Hpylori However these recommendations should be reviewed due to increased resistance rate and progressive decline in eradication therapy efficacy 20
Expert groups in USA Canada and Europe have issued treatment guidelines for the management of H pylori infection to overcome the global challenge of antibiotic resistance 13
Treatment of H pylori is still widely empiric due to antibiotic resistance which could be prevented through culture guided therapy that associated with higher eradication rates 2122
Some experts such as the Maastricht guidelines recommend clarithromycin susceptibility testing before prescribing clarithromycin triple regimen or after second line regimen failure its preferable to have this test in an earlier phase than waiting for two treatment failures mostly due to increased levofloxacin resistance a component of many second line therapies 142324
Antibiotic susceptibility testing can be done by culture or molecular methods both of which require gastric biopsies However This test is less cost-effective to be adopted widespread 23 The scarcity of such data in USA was an obstacle to make strong evidence-based treatment recommendations in the 2017 ACG guideline on H pylori treatment 19
In USA only two publications in the previous 20 years including fewer than 500 strains of H pylori have revealed resistance features 132526 A recent study compared the efficacy of first-line Hpylori eradication therapies including STT BQT sequential therapy ST consisting of a PPI and amoxicillin for 5-7 days followed by a PPI clarithromycin and a metronidazole for 5-7 days and HT Results revealed that hybrid regimen had the best Hpylori eradication rates 27
Another study compared the efficacy of different regimens for eradication of H pylori had shown that A 14-day hybrid therapy has attracted global attention as this regimen proved to be safe well tolerated and effective in high antibiotic resistance settings 2829
A current hybrid therapy HT PPI and amoxicillin for 14 days followed by clarithromycin and a nitroimidazole for 7 days is a promising first-line strategy for H pylori eradication due to the rising prevalence of antibiotic resistance globally 30
To the best of our knowledge there is lacking information about hybrid regimen efficacy in eradication of Hpylori infection in Egyptian patients our study aimed to investigate the efficacy and safety of hybrid regimen as a first line therapy for H pylori eradication compared to triple and quadruple regimens in attempt to overcome antibiotic resistance
While this pathogen in Egypt is a public health issue the propagation of H pylori infection is approximately 80 2 study results concluded that H pylori infection in upper Egypt was higher than in urban areas 3
Transmission modes of H pylori are very controversial the reservoir of H pylori is the human stomach The main method of acquisition in both developing and developed countries by fecal oral route whereas the other route of transmission in developed countries is the gastro-oral route mainly water borne prevalence overcrowding of the family of large number members institutionalized children are predisposing for acquiring the infection 46 and occupational risk factor for health members in particular those working in gastrointestinal units 7 Over spread of the infection in upper Egypt could be due to the hygiene level socioeconomic conditions life style and absence of sources of pure water supply in rural areas 3
H pylori has been classified as one of the 12 bacterial species need high priority future strategies for new antibiotic development by the World Health Organization WHO management of H pylori is widely debatable due to high antibiotics resistance prevalence after exclusion of inadequate gastric suppression by proton pump inhibitor and poor adherence to the therapy Furthermore the efficacy of many regimens has declined due to increased antibiotic resistance making H pylori eradication challenging H pylori treatment has been complicated and has required 10 and 14 days of multiple daily doses of three or four different medicines 813
There is no worldwide accepted regimen for the eradication of H pylori infection Standard triple therapy STT with proton pump inhibitors PPI in standard dose clarithromycin 500 mg and amoxicillin 1 g twice daily for 14 days is the standard triple first line regimen in the published international guidelines of the European Helicobacter and Microbiota Study Group in areas of low clarithromycin resistance 14
A randomized controlled trial in Japan showed that clarithromycin resistance is a growing problem found metronidazole to be superior to clarithromycin as a 7-day first-line triple regimen 15
In regions with low dual clarithromycin and metronidazole resistance 15 either a bismuth quadruple therapy BQT PPI bismuth salt tetracycline and metronidazole or non-bismuth concomitant quadruple therapy PPI amoxicillin clarithromycin and metronidazole is recommended 1416 In areas of high dual clarithromycin and metronidazole resistance 15 bismuth quadruple therapy is the recommended regimen However bismuth isnt available in all regions and not preferred due to complexity and the high pill burden 14 pills per day Therefore levofloxacin rifabutin or high dose dual amoxicillin and PPI therapies have been suggested 1417
A levofloxacin triple therapy is recommended as second-line treatment in case of first line therapy failure However clarithromycin-based triple therapy or bismuth quadruple therapy are alternative second-line options if not used as first line regimen and clarithromycin resistance is known to be low
Third-line and subsequent treatment strategies should be guided by antimicrobial susceptibility testing treatment durations of 14 days and the use of newer generation PPIs are recommended in all H pylori regimens unless local evidence suggests that 10 days therapy is efficient 141819 In Egypt the first and second line H pylori regimens as the international guidelines are used to eradicate Hpylori However these recommendations should be reviewed due to increased resistance rate and progressive decline in eradication therapy efficacy 20
Expert groups in USA Canada and Europe have issued treatment guidelines for the management of H pylori infection to overcome the global challenge of antibiotic resistance 13
Treatment of H pylori is still widely empiric due to antibiotic resistance which could be prevented through culture guided therapy that associated with higher eradication rates 2122
Some experts such as the Maastricht guidelines recommend clarithromycin susceptibility testing before prescribing clarithromycin triple regimen or after second line regimen failure its preferable to have this test in an earlier phase than waiting for two treatment failures mostly due to increased levofloxacin resistance a component of many second line therapies 142324
Antibiotic susceptibility testing can be done by culture or molecular methods both of which require gastric biopsies However This test is less cost-effective to be adopted widespread 23 The scarcity of such data in USA was an obstacle to make strong evidence-based treatment recommendations in the 2017 ACG guideline on H pylori treatment 19
In USA only two publications in the previous 20 years including fewer than 500 strains of H pylori have revealed resistance features 132526 A recent study compared the efficacy of first-line Hpylori eradication therapies including STT BQT sequential therapy ST consisting of a PPI and amoxicillin for 5-7 days followed by a PPI clarithromycin and a metronidazole for 5-7 days and HT Results revealed that hybrid regimen had the best Hpylori eradication rates 27
Another study compared the efficacy of different regimens for eradication of H pylori had shown that A 14-day hybrid therapy has attracted global attention as this regimen proved to be safe well tolerated and effective in high antibiotic resistance settings 2829
A current hybrid therapy HT PPI and amoxicillin for 14 days followed by clarithromycin and a nitroimidazole for 7 days is a promising first-line strategy for H pylori eradication due to the rising prevalence of antibiotic resistance globally 30
To the best of our knowledge there is lacking information about hybrid regimen efficacy in eradication of Hpylori infection in Egyptian patients our study aimed to investigate the efficacy and safety of hybrid regimen as a first line therapy for H pylori eradication compared to triple and quadruple regimens in attempt to overcome antibiotic resistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None