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Are Rectal and Genital Chlamydia Trachomatis Infections in Women Related to Anal Sex, Autoinoculation / Contamination

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ClinicalTrials.gov Identifier: NCT04030949
Recruitment Status : Unknown
Verified August 2019 by Napoleon Kentarchos, Region Östergötland.
Recruitment status was:  Recruiting
First Posted : July 24, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Napoleon Kentarchos, Region Östergötland

Brief Summary:

Chlamydia trachomatis is the most common cause of sexually transmitted bacterial infection in Sweden, an infection that is notifiable according to the Communicable Diseases Act and the Communicable Diseases Ordinance.

Women account for 57 % of all cases detected since 1993. Recently published studies describe a high proportion of positive rectal chlamydia tests in women and in half of the cases there is no history of anal sex. In almost 20 % of cases, chlamydia has only been found rectally. Samples in these studies were self-collected and although the sensitivity of modern NAATs (Nucleic Acid Amplification Tests) is very high, there is even high risk of contamination of the sample due to the short anatomical distance between the vagina and the anus. Furthermore the vaginal sample has been taken prior to the rectal sample in the largest study from the Netherlands, something that further increases the risk of contamination of the rectal sample.

There are experimental animal models which support the theory that chlamydia can be transferred along the gastrointestinal tract! This is a possible explanation for the occurrence of rectal chlamydia in women who have not had anal intercourse, but it is necessary to minimize the risk of contamination.

The study will take part in three STD-clinics (2 counties) where two clinics are in the county of Östergötland (Norrköping and Linköping with totally 300 000 inhabitants) and one in the county of Jönköping (120 000 inhabitants).

The risk of contamination of the rectal samples is minimized as the rectal sample is taken first and with the use of a pediatric proctoscope (a proctoscope that is designed to examine children) which is first inserted in the anus to allow sample collection from the rectal mucosa above the pectinate line, while avoiding contact of the collecting swab with the perineal skin. Then vaginal speculum examination is performed and samples are taken from endocervix and vagina for C.trachomatis N.gonorrhoeae and M.genitalium tests. Extra samples from the anus and the vagina will be collected and immediately frozen to minus 80 degrees to allow further testing with vPCR (viability Polymerase Chain Reaction). Positive chlamydia samples will be further analyzed with a high resolution method (Multi Locus Sequence Typing, or MLST and if necessary Multi-Locus Variable number tandem repeat Analysis or MLVA) to make the discrimination of various chlamydia types possible.


Condition or disease Intervention/treatment
Chlamydia Trachomatis Genital Infection Chlamydia Trachomatis Infection of Anus and Rectum Other: No new interventions will be applied. MLST and MLVA even vPCR are tests already existing, tested and without any known adverse effects for the participants

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Month
Official Title: Are Rectal and Genital Chlamydia Trachomatis Infections in Women Related to Anal Sex, Autoinoculation / Contamination
Actual Study Start Date : August 27, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Ateendes STD clinics Östergötland physician appointment

Attendees with an appointment to a physician (if she has symptoms or if she wishes a gynecological exam).

The exam starts with an Abbot multi-collect swab taken from the anal verge, at the opening of the anal canal.

A pediatric proctoscope (a proctoscope designed and manufactured to examine children) is used for sampling the rectal specimens using an Abbot multi-collect swab and a standard Sigma swab of Sigma virocult, followed by vaginal speculum exam. Firstly samples from the lateral fornix for wet smear are collected, secondly a swab for methylene-blue staining from the endocervical orifice followed by two Abbot multi-collect swabs for chlamydia/gonorrhoea and M.genitalium respectively from the orifice, the portio and the vaginal wall and one standard Sigma swab of Sigma virocult from the same areas. Lastly a sample is collected from the distal urethra and stained with methylene blue.

Other: No new interventions will be applied. MLST and MLVA even vPCR are tests already existing, tested and without any known adverse effects for the participants
No new interventions will be applied. MLST and MLVA even vPCR are tests already existing, tested and without any known adverse effects for the participants

Ateendes STD clinics Östergötland, nurse appointment

The participant collects the rectal sample for chlamydia and gonorrhea (Abbot multi-collect swab) first and is instructed to try not to touch the perianal/perineal areas. Then the vaginal samples for chlamydia/gonorrhoea and M.genitalium are collected.

There is a group of women who have been tested positive for chlamydia by self-collected vaginal swab which is sent to the patient by mail. Those are requested to attend the STD-clinic for partner tracing and are offered antibiotic treatment with doxycycline. Those accepting to participate in the study will answer the study questions and will be tested again and a nurse will collect firstly an Abbot multi-collect swab from the anal verge, at the opening of the anal canal and then two rectal swabs using a pediatric proctoscope (one Abbot multi-collect and one standard Sigma swab of Sigma virocult) and the participant will self-collect a new vaginal sample for chlamydia/gonorrhea and one for M.genitalium (two Abbot multi-collect swabs)

Other: No new interventions will be applied. MLST and MLVA even vPCR are tests already existing, tested and without any known adverse effects for the participants
No new interventions will be applied. MLST and MLVA even vPCR are tests already existing, tested and without any known adverse effects for the participants

Ateendes STD clinics Östergötland+Jönköping partner chlamydia

Women attending the STD clinics because of a verified chlamydia infection of their current partner. This group of patients is examined and tested by a nurse or doctor before doxycycline treatment is offered.

Those accepting to participate in the study answer the questions about the experience of receptive anal sex and fellatio (and condom use) during the last 12 months and even additional questions regarding fellatio and whether it happened that a male partner ejaculated in oral cavity of the participant.

The first sample is an Abbot multi-collect swab taken from the anal verge and the anal canal and two more swabs are taken under the use of a pediatric proctoscope: one Abbot multi-collect and one standard Sigma swab of Sigma virocult and finally vaginal samples are collected (one Abbot multi-collect and one standard Sigma swab of Sigma virocult)

Other: No new interventions will be applied. MLST and MLVA even vPCR are tests already existing, tested and without any known adverse effects for the participants
No new interventions will be applied. MLST and MLVA even vPCR are tests already existing, tested and without any known adverse effects for the participants




Primary Outcome Measures :
  1. Detection of chlamydial DNA in rectal and vaginal specimens in women attending the out-patient clinics of the county of Östergötland. [ Time Frame: 2 years ]
    Detection of chlamydial DNA (NAAT) and verification of presence of viable bacteria (vPCR).Which percentage of all anogenital infections is rectal and only rectal?

  2. Molecular typing of chlamydial DNA extracted from specimens from vaginal and rectal mucosa. Frequency of concordance or discordance between chlamydial types found in respective site. [ Time Frame: 2 years ]
    Molecular typing (MLST and if needed MLVA) of chlamydial DNA in participants with simultaneous infection of the vagina and the rectum. Number of participants with simultaneous vaginal and rectal chlamydial infections with the same chlamydial type in both sites (concordance) vs number of participants with simultaneous vaginal and rectal chlamydial infections with different chlamydial type in vagina and rectum (discordance).

  3. Incidence of true rectal chlamydial infections in women not practicing anal sex. Is there statistically significant difference between those that practice fellatio or not and those that have received sperma orally or not? [ Time Frame: 2 years ]
    Among participants with positive rectal chlamydial tests there will exist a subgroup not practicing anal sex according to the results of previous studies. If the theory of orogastrointestinal proliferation is possible in humans, then among those women there should be a number practicing fellatio and the number of those receiving sperm orally could more often have a rectal infection.

  4. Chlamydia infection specificity of swabs taken without proctoscope vs swabs taken with pediatric proctoscope. Risk for false positive for swabs taken with and without pediatric proctoscope. [ Time Frame: 2 years ]
    How many positive rectal chlamydia tests are verified as true infections with a positive vPCR and how many positive rectal chlamydia tests are a result of DNA contamination? Which is the true sensitivity of self-taken rectal tests and how often are self-taken tests false positive?

  5. Grade of discomfort and willingness of participants to undergo rectal sampling with a pediatric proctoscope. [ Time Frame: 2 years ]

    All participants will be asked to fill a standard questionnaire after the proctoscopy. The grade of discomfort will be assessed by each participant with the help of a Visual Analogue Scale (VAS), where the one end is equal to no discomfort and the other is equal to the worst discomfort experienced.

    The willingness of the participants to take the rectal tests the same way in the future if requested will be assessed by each participant again with the help of a Visual Analogue Scale, where then one end is equal to willing to take the rectal tests the same way again, while the other end equal to not willing.

    Both scales will consist of 100 mm long lines and the results will be measured according to the intervals of 0-4 mm (no discomfort/willing), 5-44 mm (mild discomfort/probably willing), 45-74 mm (moderate discomfort/probably not willing) and 75-100 mm (severe discomfort/ not willing).



Secondary Outcome Measures :
  1. Frequency of symptoms in patients with a rectal chlamydial infection. [ Time Frame: 2 years ]
    Frequency of symptoms in patients with a rectal chlamydial infection. How often do participants with rectal chlamydia infection experience symptoms?

  2. Comparison of chlamydial bacterial loads measured in chlamydia copies per milliliter between rectal and vaginal specimens. [ Time Frame: 2 years ]
    Using quantitative PCR we will compare the chlamydial bacterial load between vaginal and rectal infections, measured as chlamydia copies per milliliter given a less effective inflammatory reaction in the rectal mucosa

  3. Prevalence of non-specific cervicitis among participants with rectal chlamydial infections vs participants without rectal chlamydial infections. [ Time Frame: 2 years ]
    A possible explanation for non-specific vaginitis is a rectal chlamydial infection/reservoir that can proliferate to the vagina via autoinoculation.


Biospecimen Retention:   Samples With DNA
Secretion and epithelial cells from vaginal and rectal mucosa


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women above 18 years
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

In the county of Östergötland all attendees at the STD clinic (the cities of Norrköping and Linköping) are offered participation consecutively.

In the county of Jönköping women attending due to a verified chlamydia infection of their current partner.

Criteria

Inclusion Criteria:

  • All attendees at the STD clinic in the county of Östergötland
  • Attendees with a verified chlamydia infection of their current partner in the county of Jönköping.

Exclusion Criteria:

  • Younger than 18 years old.
  • Severe rectal disease, for example, active inflammatory bowel disease or rectal cancer.
  • Incapability to fill the questionnaire and / or understand the meaning / character of the study (eg women with language difficulties in Swedish, or mental development disorders)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030949


Contacts
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Contact: Napoleon Kentarchos 0046101041617 ext 0046101038507 napoleon.kentarchos@regionostergotland.se
Contact: Lars Falk 0046101038507 ext 0046101038507 lars.falk@regionostergotland.se

Locations
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Sweden
Department of Dermatology and Venereology in Region Östergötland Recruiting
Linköping, County Of Östergötland, Sweden, 581 91
Contact: Napoleon Kentarchos    0046101041617    napoleon.kentarchos@regionostergotland.se   
Contact: Lars Falk    0046101038507    lars.falk@regionostergotland.se   
Department of Dermatology and Venereology in the county of Jönköping Not yet recruiting
Jönköping, Sweden, 551 85
Contact: Malin Assarsson       malin.assarsson@rjl.se   
Sponsors and Collaborators
Region Östergötland
Investigators
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Study Director: Lars Falk, Assistant Professor Region Östergötland
Additional Information:
Publications of Results:

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Responsible Party: Napoleon Kentarchos, Residence in Dermatology and Venereology the Department of Dermatology and Venereology in Region Östergötland, Region Östergötland
ClinicalTrials.gov Identifier: NCT04030949    
Other Study ID Numbers: 232100-0040
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Napoleon Kentarchos, Region Östergötland:
pediatric proctoscope
oral sex,
anal sex,
MLST,
vPCR
discordance
concordance
Additional relevant MeSH terms:
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Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infections
Communicable Diseases
Chlamydia Infections
Disease Attributes
Pathologic Processes
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses