Ano-Rectal Infection Bacterial NosISTNCT03625713
Bacterial Ano-rectitis Sexually Transmitted in a Specialized Consultation Center
An observational study of Ano-Rectal Infection Bacterial Nos, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Infectious ano-rectitis is poorly described. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly corrected in gastroenterology and new diagnostic tools are now available) and therapeutic aspects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ano-Rectal Infection Bacterial Nos
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population corresponds to patients seen in hospital, in emergency consultation or programmed for a suspicion of infectious ano-rectitis and for whom a sampling for diagnostic purposes will be carried out and addressed in microbiology.
Who may be able to join
- Patient over the age of 18
- Patient consulting or hospitalized in the proctology center
- Patient for whom an anorectal sampling will be performed for suspicion of sexually transmitted infectious ano-rectitis
Who cannot join
- Patient's opposition to participate
- Patient deprived of liberty
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
Hélène BEAUSSIER, PhD, PharmD, 0144127038, crc@hpsj.fr
About this study
Official title: Epidemiological, Clinical, Microbiological and Therapeutic Aspects of Sexually Transmitted Bacterial Ano-rectitis in a Specialized Consultation Center
Infectious ano-rectitis is poorly described. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly corrected in gastroenterology and new diagnostic tools are now available) and therapeutic aspects.
Analysis of data from this large population of patients referred to the proctology center for suspicion of Neisseria gonorrhoeae and / or Chlamydia trachomatis ano-rectitis will help identify risk factors and target prevention strategies and optimized therapeutic management.
- Conditions
- Ano-Rectal Infection Bacterial Nos
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical presentation
Prevalence of clinical signs : fever (yes/no), ulcerations (yes/no), purulent proctisis (yes/no), erythematosus proctisis (yes/no), condyloma (yes/no)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start20 Jan 2018
- Primary completion2 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ano-Rectal Infection Bacterial NosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent De Parades, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625713
- Sponsor's protocol ID
- IST
- Acronym
- IST
- Status last verified
- Apr 2023
- First submitted
- 13 Jul 2018
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological, Clinical, Microbiological and Therapeutic Aspects of Sexually Transmitted Bacterial Ano-rectitis in a Specialized Consultation Center
- ClinicalTrials.gov ID
- NCT03625713
- Acronym / sponsor ID
- IST / IST
- Conditions
- Ano-Rectal Infection Bacterial Nos
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 2 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infectious ano-rectitis is poorly described. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly corrected in gastroenterology and new diagnostic tools are now available) and therapeutic aspects.
Analysis of data from this large population of patients referred to the proctology center for suspicion of Neisseria gonorrhoeae and / or Chlamydia trachomatis ano-rectitis will help identify risk factors and target prevention strategies and optimized therapeutic management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population corresponds to patients seen in hospital, in emergency consultation or programmed for a suspicion of infectious ano-rectitis and for whom a sampling for diagnostic purposes will be carried out and addressed in microbiology.
Key inclusion criteria (3 listed)
- Patient over the age of 18
- Patient consulting or hospitalized in the proctology center
- Patient for whom an anorectal sampling will be performed for suspicion of sexually transmitted infectious ano-rectitis
Key exclusion criteria (3 listed)
- Patient's opposition to participate
- Patient deprived of liberty
- Patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the clinical presentation
Time frame: Day 1
Prevalence of clinical signs : fever (yes/no), ulcerations (yes/no), purulent proctisis (yes/no), erythematosus proctisis (yes/no), condyloma (yes/no)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent De Parades, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ano-Rectal Infection Bacterial Nos, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent De Parades, MD (0144127469, vdeparades@hpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the clinical presentation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.