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Efficacy and safety of quadruple therapy containing tigolaxant and cefuroxime in the treatment of Helicobacter pylori infection in patients with penicillin allergy

Efficacy and safety of quadruple therapy containing tigolaxant and cefuroxime in the treatment of Helicobacter pylori infection in patients with penicillin allergy

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085260
Enrollment
Unknown
Registered
2024-06-04
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori treatment

Interventions

test group:Tegolasen 50 mg 2/day Colloidal bismuth pectin 200 mg 2/day Cefuroxime axetil 500 mg 2/day Clarithromycin 500 mg 2/day
Control group:Rabeprazole 10 mg 2 times a day Colloidal bismuth pectin 200 mg 2/day Cefuroxime axetil 500 mg 2/day Clarithromycin 500 mg 2/day

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age = 18 years old and = 70 years old, both men and women are welcome; 2) Clinical diagnosis of Helicobacter pylori infection (breath test and/or stool Hp test and/or pathological confirmation of HP positivity); 3) Penicillin allergy, or penicillin skin test positive; 4) Voluntary signing of the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Use of antibiotics, PPIs, P-CABs, bismuth or non-steroidal anti-inflammatory drugs within one month; 2) Pregnancy or lactation; 3) Allergy to the drugs used in the study; 4) Taking drugs that are incompatible with the test drugs; 5) Combination with serious underlying diseases or other diseases that may lead to ineffective treatment; 6) History of gastrointestinal surgery or recent history of other types of surgery; 7) Family history of genetic diseases, history of mental illness, etc.; 8) The research subject is participating in other research projects; 9) The researchers believe that it is not suitable to continue the clinical trial for other reasons.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
The incidence of drug-related adverse reactions;

Countries

China

Contacts

Public ContactShu Qing

Shenzhen Second People's Hospital

sq6060@163.com+86 755 8336 6388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026