The relationship between stomach Helicobacter pylori infection and antibiotic consumption among HIV-positive individuals
| ISRCTN | ISRCTN13466428 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13466428 |
| Secondary identifying numbers | AK/07-12-77/3503 |
- Submission date
- 30/09/2020
- Registration date
- 03/10/2020
- Last edited
- 29/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Helicobacter pylori infection, a cause of ulcers and cancer in the stomach, and ulcers in the intestines is frequent worldwide and treatment is well established in the general population.
H. pylori infects more than half of the world’s population and HIV infects nearly thirty-eight million people. HIV-infected individuals often need treatments against infections. Compared to the general population, little is known about the H. pylori infection among HIV-co-infected individuals.
This study aimed to evaluate the presence of and evolution of primary antibiotic resistance of H. pylori strains isolated amongst HIV-co-infected (case) and -uninfected (control) individuals.
Who can participate?
Any adult aged 18 or more who have a proven H. pylori infection by microbiology examination including antimicrobial susceptibility test and have not yet been treated for H. pylori infection will be invited to participate in the study.
What does the study involve?
The study involves an agreement to use results of the microbiology examination and clinical data for the research.
What are the possible benefits and risks of participating?
There will be no direct benefit from taking part although it is hoped that participants might contribute to improve our understanding. Investigators do not anticipate any risks from taking part.
Where is the study run from?
University Hospital Saint Peter in Brussels (Belgium)
When is the study starting and how long is it expected to run for?
January 2004 to December 2023.
Who is funding the study?
Principal investigator with the support of FRPD ASBL
Who is the main contact?
Dr Marcel Nkuize, marcel.nkuize@stpierre-bru.be
Contact information
Scientific
Centre Hospitalier Universitaire de Saint-Pierre
322 Rue Haute
Brussels
1000
Belgium
 ORCID ID |
0000-0002-7708-050X |
|---|---|
| Phone | +32 25354200 |
| marcelnkuize@hotmail.com |
Scientific
Centre Hospitalier Universitaire de Saint-Pierre
322 Rue Haute
Brussels
1000
Belgium
| ORCID ID |
0000-0002-7708-050X |
|---|---|
| Phone | +32 25354200 |
| marcel.nkuize@stpierre-bru.be |
Study information
| Study design | Observational |
|---|---|
| Primary study design | Observational |
| Secondary study design | Ecological study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evolution of Helicobacter pylori primary antibiotic resistance in a cohort of individuals with and without HIV infection: role of antibiotics consumption |
| Study acronym | HPPARHIV |
| Study hypothesis | To evaluate prevalence and evolution of primary antibiotic resistance of Helicobacter pylori (H. pylori) strains isolated amongst HIV-co-infected (case) and -uninfected (control) individuals. To correlate local patient’s antibiotic resistance of H. pylori strains with nationwide antibiotic consumption. |
| Ethics approval(s) | Approved 04/12/2007, Comite Local d'Ethique Hospitalier (Rue Haute 322-1000 Brussels, Belgium; +3225354481; comite_ethique@stpierre-bru.bee), ref: AK/07-12-77/3503 |
| Condition | Helicobacter pylori antimicrobial susceptibility in people with HIV infection |
| Intervention | Participants who fulfil inclusion criteria will be asked to give consent for the team to collect clinical information, as well as data related to H. pylori diagnosis. We prospectively collected in a registry, data of local outpatients, from 1st of January, 2004 till 31st of December, 2015. We collected Nationwide outpatient (with and without HIV infection) antibiotic consumption during the same period since 1st of January, 2004 till 31st of December, 2015. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Primary H. pylori antibiotic resistance is evaluated by anamnesis and by microbial examination of gastric samples using disk diffusion methods (Neo-Sensitabs; Rosco, Taastrup, Denmark), and the minimum inhibitory concentration (MIC) determined by an agar dilution method at a single time point 2. Antibiotic consumption within the country during the period studied, measured by defined daily dose per 1000 inhabitants using national records |
| Secondary outcome measures | Measured at the time of H. pylori diagnosis: 1. Demographics measured using anamnesis, medical records, and hospital database 2. History of H. pylori treatment obtained by anamnesis, patient’s medical chart, phone contact with the family medical doctor 3. HIV status measured using medical records 4. HIV viral load (measured using COBAS AmpliPrep/COBAS Amplicor HIV-1 Monitor Test v1.0, 1COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 real time PCR) 5. Lymphocyte T CD4 count (measured using flow cytometry, NAVIOS) 6. Chemoprevention against Toxoplasma gondii or Pneumocystis jiroveci ( with trimethoprim-sulfamethoxazole ) or anti-malaria drug use (including mefloquine, atovaquone, chloroquine, primaquine) 7. Consequences of infection measured by endoscopy performed using video Olympus GIF-q165, GIF-HQ 190 and gastric biopsy |
| Overall study start date | 01/01/2004 |
| Overall study end date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Equal or more than 180 cases |
| Total final enrolment | 8321 |
| Participant inclusion criteria | 1. No history of H. pylori treatment 2. Ambulatory HIV-positive and HIV-negative individuals 3. Naïve to H. pylori treatment 4. Aged ≥18 years 5. Underwent upper gastrointestinal endoscopy for any reason and for which H. pylori antimicrobial susceptibility test results is available |
| Participant exclusion criteria | 1. Coagulopathy 2. Partial gastrectomy 3. Does not agree to participate |
| Recruitment start date | 01/01/2006 |
| Recruitment end date | 31/12/2015 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Brussels
1000
Belgium
Sponsor information
Hospital/treatment centre
322 Rue Haute
Brussels
1000
Belgium
| Phone | +3225354200 |
|---|---|
| infectiousdieases@stpierre-bru.be | |
| Website | http://www.stpierre-bru.be/en/index.html |
"ROR" |
https://ror.org/05cmp5q80 |
Funders
Funder type
Not defined
No information available
No information available
Results and Publications
| Intention to publish date | 31/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The protocol is not available online but can be provided upon request. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2021 | 29/06/2021 | Yes | No |
Editorial Notes
29/06/2021: Publication reference added.
02/10/2020: Trial’s existence confirmed by Comite Local d'Ethique Hospitalier Universitaire St. Pierre.
