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Trial no.:
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PACTR202112632957229 |
Date of Registration:
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07/12/2021 |
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Trial Status:
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Retrospective registration - This trial was registered after enrolment of the first participant |
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| TRIAL DESCRIPTION |
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Public title
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Optimized sequential therapy versus 10 and 14-day concomitant therapy for eradicating Helicobacter Pylori : A randomized clinical trial |
| Official scientific title |
Fourteen-day sequential therapy containing Rabeprazole versus 10 and 14-day concomitant therapy in the first line treatment of Helicobacter Pylori infection: A randomized, open-label clinical trial |
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Brief summary describing the background
and objectives of the trial
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The decline in the efficacy of traditional triple therapies has generated since 2010 new combinations of antibiotics for Helicobacter Pylori eradication. The last guidelines of Maastricht V recommend concomitant quadruple therapies or bismuth quadruple therapies to reach an eradication rate of at least 90%. These values remain higher than those obtained with standard sequential therapy, but with higher cost and more adverse effects.
Aims:
To compare an optimized sequential therapy to 10 and 14-day non-Bismuth quadruple therapies currently recommended, in terms of efficacy, incidence of adverse effects and cost.
Patients and methods:
A single-center, prospective, open, randomized study will be conducted over a period of 2 years and 3 months at department of Gastroenterology and Gastrointestinal Endoscopy II of Mohamed V Military Teaching Hospital of Rabat, Morocco. Patients with confirmed Helicobacter pylori (H. Pylori) infection will be randomized into 3 groups (1: 1: 1): the first group will receive quadruple therapy of omeprazole twice daily (bid) 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for 10 days (QT-10), the second group will receive 14-day quadruple therapy following the same schedule (QT-14), and the third will receive optimized sequential therapy consisting of a bid dose Rabeprazole 20 mg plus amoxicillin 1g for 7 days, followed by bid Rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500 mg for the next 7 days (OST-14). Adverse events (AEs) will be recorded throughout the study and the H. Pylori eradication rate will be determined 4-6 weeks after treatment using the 13C urea breath test.
Expected results: Optimized 14-day sequential therapy would be a safe and effective alternative to quadruple therapy of 10 and 14 days with fewer side effects and cost savings.
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| Type of trial |
RCT |
| Acronym (If the trial has an acronym then please provide) |
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| Disease(s) or condition(s) being studied |
Digestive System |
| Sub-Disease(s) or condition(s) being studied |
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| Purpose of the trial |
Treatment: Drugs |
| Anticipated trial start date |
10/01/2018 |
| Actual trial start date |
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| Anticipated date of last follow up |
15/08/2020 |
| Actual Last follow-up date |
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| Anticipated target sample size (number of participants) |
312 |
| Actual target sample size (number of participants) |
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| Recruitment status |
Closed to recruitment,follow-up continuing |
| Publication URL |
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