NCT04030949

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

Status unknown Last updated 3 September 2019

What this trial tests

trial testing 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 in Chlamydia Trachomatis Genital Infection in 600 participants. Status unknown.

Timeline

27 August 2019

Primary endpoint
31 August 2021

1 August 2022

Quick facts

Lead sponsor	Region Östergötland
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	600
Start date	27 August 2019
Primary completion	31 August 2021
Estimated completion	1 August 2022
Sites	2 locations across Sweden

Drugs / interventions tested

• 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

Conditions studied

• Chlamydia Trachomatis Genital Infection — all drugs for Chlamydia Trachomatis Genital Infection →
• Chlamydia Trachomatis Infection of Anus and Rectum — all drugs for Chlamydia Trachomatis Infection of Anus and Rectum →

Sponsor

Region Östergötland

Who can join

18 and older, female only, with Chlamydia Trachomatis Genital Infection or Chlamydia Trachomatis Infection of Anus and Rectum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Controversies and evidence on Chlamydia testing and treatment in asymptomatic women and men who have sex with men: a narrative review.
   Dukers-Muijrers NHTM, Evers YJ, Hoebe CJPA, Wolffs PFG, et al · · 2022 · cited 33× · PMID 35287617 · DOI 10.1186/s12879-022-07171-2