Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200779
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-12-12
Brief Title:
Tailored vs Empirical Helicobacter Pylori Infection Treatment
Sponsor:
Manuel Coelho da Rocha
Organization:
Unilabs Portugal
Study Overview
Official Title:
Susceptibility-guided vs Empirical First-line Bismuth Quadruple Therapy of H Pylori Infection a National Prospective Multicentric Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Helicobacter pylori Hp is a gram-negative bacterium that colonizes human gastric mucosa and is associated with chronic gastritis that can progress to severe complications such as peptic ulcer disease gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma More than half of the worlds population is infected with H pylori and Portugal is one of the countries with the highest Hp burden All of infected patients should be treated however H pylori treatment is challenged by the continuously rising antibiotic resistance which has reached alarming levels worldwide For this reason it is now well accepted that tailoring treatment of H pylori infection based on systematic antimicrobial susceptibility testing is useful to avoid the increase of antibiotic resistance
Our aims are to determine prospectively the efficacy and safety of first-line H pylori eradication treatment based on resistance profile determined by molecular methods vs empirical bismuth quadruple therapy to evaluate the accuracy of H pylori detection by polymerase chain reaction PCR vs histopathological examination and to estimate the prevalence of H pylori infection and H pylori resistance to clarithromycin and levofloxacin in Portugal
This prospective study will be the first national study to investigate the benefits of tailored H pylori eradication treatment The investigators expect that this project will be able to demonstrate the non-inferiority of susceptibility-guided treatment comparing with empirical therapy and our results may change H pylori treatment recommendations by systematically applying antibiotic susceptibility testing before prescribing eradication therapy
Our aims are to determine prospectively the efficacy and safety of first-line H pylori eradication treatment based on resistance profile determined by molecular methods vs empirical bismuth quadruple therapy to evaluate the accuracy of H pylori detection by polymerase chain reaction PCR vs histopathological examination and to estimate the prevalence of H pylori infection and H pylori resistance to clarithromycin and levofloxacin in Portugal
This prospective study will be the first national study to investigate the benefits of tailored H pylori eradication treatment The investigators expect that this project will be able to demonstrate the non-inferiority of susceptibility-guided treatment comparing with empirical therapy and our results may change H pylori treatment recommendations by systematically applying antibiotic susceptibility testing before prescribing eradication therapy
Detailed Description:
A prospective multicenter randomized controlled interventional trial in two arms intervention group and control group
Eligible patients will receive oral and written information and will be enrolled after giving written informed consent
In all patients complete gastroscopy with white light will be performed and endoscopic findings will be recorded For each patient gastric body and antral biopsies will be collected All gastric samples will be tested for H pylori infection by histopathological examination and PCR All H pylori positive samples will be tested for clarithromycin mutations in the 23S rRNA gene A2134G A2142G and A2142C mutations and levofloxacin resistance mutations in the gyrA gene by PCR
All H pylori positive patients will be randomized in two groups
INTERVENTION GROUP Patients randomized to the Intervention group will receive a prescription for oriented H pylori eradication treatment according to the following rules a clarithromycin-sensitive strain independently of levofloxacin resistance test result - PPI amoxicillin 1 g and clarithromycin 500 mg twice daily for 10 days b clarithromycin-resistant and levofloxacin-sensitive strain - PPI amoxicillin 1g and levofloxacin 250 mg twice daily for 10 days c clarithromycin-resistant and levofloxacin-resistant strain - bismuth quadruple therapy Pylera for 10 days At least 4 weeks after stopping antibiotics and at least 2 weeks after stopping PPIs an eradication control test will be carried out using a respiratory test urea breath test or endoscopic biopsies if clinical indication for that
CONTROL GROUP Patients randomized to the Control group will receive a prescription for empirically H pylori eradication treatment with bismuth quadruple therapy Pylera for 10 days At least 4 weeks after stopping antibiotics and at least 2 weeks after stopping PPIs an eradication control test will be carried out using a respiratory test urea breath test or endoscopic biopsies if clinical indication for that
All patients that complete eradication treatment regimen will be evaluated 2 to 4 weeks after performing the eradication control urea breath test in a clinical consultation Eventual adverse effects will be recorded A negative breath test will define the success of the treatment while a positive test will define treatment failure The latter will be managed according to H pylori infection guidelines
Eligible patients will receive oral and written information and will be enrolled after giving written informed consent
In all patients complete gastroscopy with white light will be performed and endoscopic findings will be recorded For each patient gastric body and antral biopsies will be collected All gastric samples will be tested for H pylori infection by histopathological examination and PCR All H pylori positive samples will be tested for clarithromycin mutations in the 23S rRNA gene A2134G A2142G and A2142C mutations and levofloxacin resistance mutations in the gyrA gene by PCR
All H pylori positive patients will be randomized in two groups
INTERVENTION GROUP Patients randomized to the Intervention group will receive a prescription for oriented H pylori eradication treatment according to the following rules a clarithromycin-sensitive strain independently of levofloxacin resistance test result - PPI amoxicillin 1 g and clarithromycin 500 mg twice daily for 10 days b clarithromycin-resistant and levofloxacin-sensitive strain - PPI amoxicillin 1g and levofloxacin 250 mg twice daily for 10 days c clarithromycin-resistant and levofloxacin-resistant strain - bismuth quadruple therapy Pylera for 10 days At least 4 weeks after stopping antibiotics and at least 2 weeks after stopping PPIs an eradication control test will be carried out using a respiratory test urea breath test or endoscopic biopsies if clinical indication for that
CONTROL GROUP Patients randomized to the Control group will receive a prescription for empirically H pylori eradication treatment with bismuth quadruple therapy Pylera for 10 days At least 4 weeks after stopping antibiotics and at least 2 weeks after stopping PPIs an eradication control test will be carried out using a respiratory test urea breath test or endoscopic biopsies if clinical indication for that
All patients that complete eradication treatment regimen will be evaluated 2 to 4 weeks after performing the eradication control urea breath test in a clinical consultation Eventual adverse effects will be recorded A negative breath test will define the success of the treatment while a positive test will define treatment failure The latter will be managed according to H pylori infection guidelines
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