Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06200779 |
| Other study ID # |
Clinical Study Protocol 1 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
September 2024 |
| Est. completion date |
November 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Unilabs Portugal |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 world's 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.
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.
