Condition category
Infections and Infestations
Date applied
30/09/2020
Date assigned
03/10/2020
Last edited
03/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marcel Nkuize

ORCID ID

http://orcid.org/0000-0002-7708-050X

Contact details

Centre Hospitalier Universitaire de Saint-Pierre
322 Rue Haute
Brussels
1000
Belgium
+32 25354200
marcelnkuize@hotmail.com

Type

Scientific

Additional contact

Dr Marcel Nkuize

ORCID ID

http://orcid.org/0000-0002-7708-050X

Contact details

Centre Hospitalier Universitaire de Saint-Pierre
322 Rue Haute
Brussels
1000
Belgium
+32 25354200
marcel.nkuize@stpierre-bru.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

AK/07-12-77/3503

Study information

Scientific title

Evolution of Helicobacter pylori primary antibiotic resistance in a cohort of individuals with and without HIV infection: role of antibiotics consumption

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

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

Study design

Observational

Primary study design

Observational

Secondary study design

Ecological study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

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 trial start date

01/01/2004

Overall trial end date

31/12/2023

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Equal or more than 180 cases

Total final enrolment

8321

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

Trial participating centre

University Hospital Saint Peter
322 Rue Haute
Brussels
1000
Belgium

Sponsor information

Organisation

Centre Hospitalier Universitaire de Saint-Pierre

Sponsor details

322 Rue Haute
Brussels
1000
Belgium
+3225354200
infectiousdieases@stpierre-bru.be

Sponsor type

Hospital/treatment centre

Website

http://www.stpierre-bru.be/en/index.html

Funders

Funder type

Not defined

Funder name

Principal Investigator

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fond de recherche en pathologie digestive, FRDP ASBL

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

31/01/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/10/2020: Trial’s existence confirmed by Comite Local d'Ethique Hospitalier Universitaire St. Pierre.