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

NCT04030949 | Unknown

• 1 other identifier: 232100-0040
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Chlamydia Trachomatis Genital Infection; Chlamydia Trachomatis Infection of Anus and Rectum

Keywords

pediatric proctoscope; oral sex,; anal sex,; MLST,; vPCR; discordance; concordance

Outcome Measures

Primary Outcomes (5)

• Detection of chlamydial DNA in rectal and vaginal specimens in women attending the out-patient clinics of the county of Östergötland.

  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 years

• 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.

  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).

  2 years

• 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?

  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.

  2 years

• 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.

  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?

  2 years

• Grade of discomfort and willingness of participants to undergo rectal sampling with a pediatric proctoscope.

  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).

  2 years

Secondary Outcomes (3)

• Frequency of symptoms in patients with a rectal chlamydial infection.

  2 years

• Comparison of chlamydial bacterial loads measured in chlamydia copies per milliliter between rectal and vaginal specimens.

  2 years

• Prevalence of non-specific cervicitis among participants with rectal chlamydial infections vs participants without rectal chlamydial infections.

  2 years

Study Arms (3)

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

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

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

Interventions

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 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

Ateendes STD clinics Östergötland physician appointment; Ateendes STD clinics Östergötland+Jönköping partner chlamydia; Ateendes STD clinics Östergötland, nurse appointment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women above 18 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Region Östergötland: lead

Study Sites (2)

Department of Dermatology and Venereology in Region Östergötland

Linköping, County of Östergötland, 581 91, Sweden

RECRUITING

Department of Dermatology and Venereology in the county of Jönköping

Jönköping, 551 85, Sweden

NOT YET RECRUITING

Related Publications (11)

• Falk L. The overall agreement of proposed definitions of mucopurulent cervicitis in women at high risk of Chlamydia infection. Acta Derm Venereol. 2010 Sep;90(5):506-11. doi: 10.2340/00015555-0924.

  PMID: 20814628 RESULT

• Taylor SN. Cervicitis of unknown etiology. Curr Infect Dis Rep. 2014 Jul;16(7):409. doi: 10.1007/s11908-014-0409-x.

  PMID: 24859465 RESULT

• Klint M, Fuxelius HH, Goldkuhl RR, Skarin H, Rutemark C, Andersson SG, Persson K, Herrmann B. High-resolution genotyping of Chlamydia trachomatis strains by multilocus sequence analysis. J Clin Microbiol. 2007 May;45(5):1410-4. doi: 10.1128/JCM.02301-06. Epub 2007 Feb 28.

  PMID: 17329456 RESULT

• Andersson N, Boman J, Nylander E. Rectal chlamydia - should screening be recommended in women? Int J STD AIDS. 2017 Apr;28(5):476-479. doi: 10.1177/0956462416653510. Epub 2016 Jul 10.

  PMID: 27235696 RESULT

• van Liere GAFS, Dukers-Muijrers NHTM, Levels L, Hoebe CJPA. High Proportion of Anorectal Chlamydia trachomatis and Neisseria gonorrhoeae After Routine Universal Urogenital and Anorectal Screening in Women Visiting the Sexually Transmitted Infection Clinic. Clin Infect Dis. 2017 Jun 15;64(12):1705-1710. doi: 10.1093/cid/cix243.

  PMID: 28369227 RESULT

• Schachter J, Grossman M, Sweet RL, Holt J, Jordan C, Bishop E. Prospective study of perinatal transmission of Chlamydia trachomatis. JAMA. 1986 Jun 27;255(24):3374-7.

  PMID: 3712696 RESULT

• Rank RG, Yeruva L. Hidden in plain sight: chlamydial gastrointestinal infection and its relevance to persistence in human genital infection. Infect Immun. 2014 Apr;82(4):1362-71. doi: 10.1128/IAI.01244-13. Epub 2014 Jan 13.

  PMID: 24421044 RESULT

• Carre H, Edman AC, Boman J, Nylander E. Chlamydia trachomatis in the throat: is testing necessary? Acta Derm Venereol. 2008;88(2):187-8. doi: 10.2340/00015555-0382. No abstract available.

  PMID: 18311460 RESULT

• Sethupathi M, Blackwell A, Davies H. Rectal Chlamydia trachomatis infection in women. Is it overlooked? Int J STD AIDS. 2010 Feb;21(2):93-5. doi: 10.1258/ijsa.2008.008406. Epub 2009 Nov 16.

  PMID: 19917639 RESULT

• Foschi C, Salvo M, Cevenini R, Marangoni A. Chlamydia trachomatis antimicrobial susceptibility in colorectal and endocervical cells. J Antimicrob Chemother. 2018 Feb 1;73(2):409-413. doi: 10.1093/jac/dkx392.

  PMID: 29077843 RESULT

• Herrmann B, Isaksson J, Ryberg M, Tangrot J, Saleh I, Versteeg B, Gravningen K, Bruisten S. Global Multilocus Sequence Type Analysis of Chlamydia trachomatis Strains from 16 Countries. J Clin Microbiol. 2015 Jul;53(7):2172-9. doi: 10.1128/JCM.00249-15. Epub 2015 Apr 29.

  PMID: 25926497 RESULT

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Secretion and epithelial cells from vaginal and rectal mucosa

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lars Falk, Assistant Professor

  Region Östergötland

  STUDY DIRECTOR

Central Study Contacts

Napoleon Kentarchos

CONTACT

0046101041617; napoleon.kentarchos@regionostergotland.se

Lars Falk

CONTACT

0046101038507; lars.falk@regionostergotland.se

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residence in Dermatology and Venereology the Department of Dermatology and Venereology in Region Östergötland

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 24, 2019
• Study Start: August 27, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 1, 2022
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)