Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003257400 Date of Approval: 28/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Helicobacter pylori Treatment Success Rate amongst Rwandan Endoscopy Patients
Official scientific title Helicobacter pylori Treatment Success Rate amongst Rwandan Endoscopy Patients
Brief summary describing the background and objectives of the trial The prevalence of H. pylori infection is greatest in countries of the developing world with a 75% prevalence in the general population in Rwanda. There are several protocols for H. Pylori eradication worldwide that are usually based on local antibiotic resistance rates. The current standard of care in Rwanda is triple therapy with omeprazole, amoxicillin and clarithromycin. This is a relatively expensive regimen of treatment and its efficacy compared with alternative combinations available in Rwanda is not known. This study will be conducted to assess the H. Pylori eradication rate following standard triple therapy in Rwanda and to evaluate the efficacy of alternative eradication therapeutic regimens that are less expensive and that are available in Rwanda. The health related quality of life in this population was also assed using the Short Form Nepean Dyspepsia Index. Study participants were adults aged 21 years and above, referred for upper gastro-intestinal endoscopy at Butare University Teaching Hospital who had a positive modified rapid urease test on endoscopic biopsies. Pregnant women, patients with suspected malignancies on endoscopy and patients with known allergy to one of the study medications were excluded. Patients were randomly assigned to one of four regimens: omeprazole, amoxicillin, clarithromycin (OAC), omeprazole, ciprofloxacin, amoxicillin (OCA), omeprazole, amoxicillin, metronidazole (OAM), or omeprazole, ciprofloxacin, amoxicillin, doxycycline (OCAD). Patients and clinicians were blinded to treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,H. pylori,Infections and Infestations
Sub-Disease(s) or condition(s) being studied H. Pylori
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/11/2015
Actual trial start date 02/11/2015
Anticipated date of last follow up 31/10/2016
Actual Last follow-up date 28/11/2016
Anticipated target sample size (number of participants) 244
Actual target sample size (number of participants) 299
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Random pick up of a piece of paper from a basket Pieces of paper with 4 different regimens were mixed in a basket. A patient would choose a piece of paper randomly Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group omeprazole+ amoxicillin+ clarithromycin (CLARITHRO) omeprazole 20 mg twice daily + amoxicillin 1 g twice daily + clarithromycin 500 mg twice 10 days Take medicine as prescribed, call if any adverse effect. Patient re-evaluation 4-6 weeks after treatment 61 Active-Treatment of Control Group
Experimental Group omeprazole+ amoxicillin+ ciprofloxacin (CIPRO) omeprazole 20 mg twice daily + amoxicillin 1 g twice daily + ciprofloxacin 500 mg twice daily 10 days Take medicine as prescribed, call if any adverse effect. Patient re-evaluation 4-6 weeks after treatment 61
Experimental Group omeprazole+ amoxicillin+ metronidazole (METRO) omeprazole 20 mg twice daily + amoxicillin 1 g twice daily + metronidazole 500 mg three times 10 days Take medicine as prescribed, call if any adverse effect. Patient re-evaluation 4-6 weeks after treatment 61
Experimental Group omeprazole+ amoxicillin+ ciprofloxacin+Doxycyclin) (CIPRO-Plus) omeprazole 20 mg twice daily + amoxicillin 1 g twice daily+ ciprofloxacin 500 mg twice daily+ doxycycline 100 mg twice daily 10 days Take medicine as prescribed, call if any adverse effect. Patient re-evaluation 4-6 weeks after treatment 61
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults aged 21 years and above Referred for upper gastro-intestinal endoscopy at Butare University Teaching Hospital Positive modified rapid urease test on endoscopic biopsies study medications Pregnant women Patients with suspected malignancies on endoscopy Patients with known allergy to one of the 21 Year(s) 120 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/03/2015 CMHS Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
KK 737 Street Kigali Rwanda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Evidence of H. Pylori eradication 4 to 6 weeks after treatment
Primary Outcome Health related quality of life score change by SF-NDI 4 to 6 weeks after treatmen
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Butare University teaching Hospital Butare Butare Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
Butare University Teaching Hospital Butare Butare Rwanda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Butare University Teaching Hospital Butare Butare Rwanda Hospital
COLLABORATORS
Name Street address City Postal code Country
Tim Walker Butare Butare Rwanda
Claude Bayingana Butare Butare Rwanda
DeVon Hale Butare Butare Rwanda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jean Damascene Kabakambira damaskabakambira@gmail.com +12023447389 5407 W Cedar Ln
City Postal code Country Position/Affiliation
Bethesda, Maryland United States of America Research Fellow
Role Name Email Phone Street address
Public Enquiries Jean Damascene Kabakambira damaskabakambira@gmail.com +12023447389 5407 W Cedar Ln
City Postal code Country Position/Affiliation
Bethesda 20814 United States of America Research Fellow/ NIH
Role Name Email Phone Street address
Public Enquiries Celestin Hategeka celestin.hategeka@gmail.com +17789907941
City Postal code Country Position/Affiliation
Vancouver Canada Epidemiologist
Role Name Email Phone Street address
Scientific Enquiries Tim Walker timwalkerd@gmail.com +250784206851 Edith St Waratah NSW Australia 2298
City Postal code Country Position/Affiliation
Edith St Warata Australia Gastroenterologist
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information