Tailored Vs. Empirical Helicobacter Pylori Infection Treatment

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

December 31, 2026

Conditions
Helicobacter Pylori Infection
Interventions
DIAGNOSTIC_TEST

Clarithromycin (mutations in the 23S rRNA gene, A2134G, A2142G and A2142C mutations) and levofloxacin resistance (mutations in the gyrA gene) PCR test

"Described in Arms section"

DRUG

Empirically H. pylori eradication treatment with bismuth quadruple therapy (Pylera®)

"Described in Arms section"

DRUG

PPI, amoxicillin 1 g and clarithromycin 500 mg, twice daily, for 10 days

Administered to patients randomized to Intervention group and with H. pylori clarithromycin-sensitive strain

DRUG

PPI, amoxicillin 1g and levofloxacin 250 mg, twice daily, for 10 days

Administered to patients randomized to Intervention group and with H. pylori clarithromycin-resistant and levofloxacin-sensitive strain

DRUG

Bismuth quadruple therapy (Pylera®) for 10 days

Administered to patients randomized to Intervention group and with H. pylori clarithromycin-resistant and levofloxacin-resistant strain

Trial Locations (1)

4150-178

Unilabs Portugal, Porto

All Listed Sponsors
lead

Manuel Coelho da Rocha

OTHER