Clinical trial NCT01481844: Sequential Therapy Versus Quadruple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Optimization of Second Line Treatment Protocol for H Pylori Eradication
Keywords: sequential therapy
second line treatment
H pylori
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI + amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and tinidazole ) versus quadruple drug regimen( i.e.-14 days of PPI+ bismuth + metronidazole + tetracycline ) as second line treatment of H. pylori .

Detailed description: a total of 101 patients were randomized to 2 groups : 50 in sequential group and 51 patients in quadruple group . mean age was 43 in both groups. In sequential therapy group 42 patients(84%) completed the treatment , 39 patients returned to follow up . In quadruple group only 33 patients (64.7%) completed the treatment , 29 of them returned to follow up.

Compliance to the treatment was significant better in sequential group comparative to quadruple .Sides effects connected to gastro-intestinal tract were reported in 27(65.9%) of quadruple group patients and in 19(43.2%)of sequential group.

The H pylori was eradicated in 23 of 39 patients in sequential group(59%), and in 19 of the 29 patients in quadruple group(65.5%). no comorbidities like smoking, diabetes or other influenced the efficacy of eradication.

Sequential therapy showed the same eradication rate as second line treatment of H pylori as quadruple one, but was associated with better compliance and less adverse effects.

Both treatments protocols failed to show an appropriate eradication rate in population of Southern Israel .

Eligibility criteria: Inclusion Criteria:

1. signed informed consent
2. age at least 18 years
3. persisting H.pylori infection after at least one course of first-line standard triple therapy (Amoxycillin, Clarithromycin or Metronidazole based)

Exclusion Criteria:

1. history of gastrectomy
2. gastric malignancy, including adenocarcinoma and lymphoma
3. previous allergic reaction to antibiotics (amoxicillin, clarithromycin, metronidazole, tetracycline) and proton pump inhibitors
4. Active upper gastrointestinal bleeding within the previous 1 week
5. contraindications to the treatment drugs
6. Pregnant or lactating women
7. Severe concurrent disease or malignancy

Primary outcomes:
measure: The eradication rate after second line treatment based on sequential therapy comparative to eradication rate after second line therapy based on quadriple regimen
timeFrame: 18 month
Secondary outcomes:
measure: The secondary end points: Adverse effects of sequential and quadruple treatment
timeFrame: 18 months
measure: compliance with treatment
timeFrame: 18 months
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroca UMC
Study officials:
affiliation: Soroka UMC
name: Daniela Munteanu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munteanu D, Etzion O, Ben-Yakov G, Halperin D, Eidelman L, Schwartz D, Novack V, Abufreha N, Krugliak P, Rozenthal A, Gaspar N, Moshkalo A, Dizingof V, Fich A. Efficacy and safety of sequential versus quadruple therapy as second-line treatment for helicobacter pylori infection-A randomized controlled trial. PLoS One. 2017 Sep 28;12(9):e0183302. doi: 10.1371/journal.pone.0183302. eCollection 2017.