View clinical trials related to Chlamydia Infections.
Filter by:A Multicentre, controlled, randomized trial of 3 site (urethra, pharynx and rectum) sampling performed every 3 months (3x3) for Neisseria gonorrhoea (Ng)/Chlamydia trachomatis (Ct) screening (comparator) vs. no screening (intervention).
Objectives: To compare self-taken penile meatal swabs versus first-catch urine samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium from the penile urethra using nucleic acid amplification tests. To assess the acceptability of self-taken penile meatal swabs compared with first-catch urine samples. To assess the prevalence of Mycoplasma genitalium in those with urethritis. To assess the prevalence of Mycoplasma genitalium antimicrobial resistance. To evaluate the utility of using Mycoplasma genitalium resistance-guided therapy. To compare the cost of using self-taken penile meatal swabs versus FCU samples for the correct detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium. Methods: Men and transwomen presenting for a sexual health screen will perform a self-taken penile meatal swab followed by a first-catch urine (FCU) sample. Both will be analysed using the Aptima Combo 2 test (Hologic, San Diego, California [CA], USA) for chlamydia and gonorrhoea. In those with urethritis they will also be analysed using Aptima MGen test for Mycoplasma genitalium. Details of demographics, past history, sexual history, clinical symptoms and signs will be collected. The acceptability of each sample will be assessed using a patient questionnaire. The samples of those infected with Mycoplasma genitalium will be tested for Mycoplasma genitalium macrolide and fluoroquinolone resistance mutations by in-house polymerase chain reaction (PCR) using Sanger sequencing to characterise mutants in the 23s gene for macrolide resistance and DNA gyrase subunit A (gyrA) and DNA topoisomerase IV subunit C (parC) genes for fluoroquinolone resistance. The result of this will be used to guide the therapy prescribed to treat the infection. Primary outcome: Sensitivity, specificity, positive and negative predictive values of self-taken penile meatal swabs compared with FCU samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium in the penile urethra. Secondary outcomes: Acceptability of self-taken penile meatal swabs compared with FCU samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium. Prevalence of Mycoplasma genitalium in those with urethritis. Prevalence of Mycoplasma genitalium antimicrobial resistance. Utility of using Mycoplasma genitalium resistance-guided therapy. Cost of using self-taken penile meatal swabs versus FCU samples for the correct detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium.
As part of UCLA Health's commitment to developing a premier integrated health system built on a foundation of physician-led, team-based primary care, the Department of Medicine (DOM) recently implemented a new performance based incentive plan called the Primary Care Clinical Excellence (PCCE) Incentive Plan. This incentive plan was developed to motivate providers to improve health maintenance screening rates. The UCLA Health DOM Quality team is leading the implementation and evaluation of this new incentive plan across our primary care network. In addition, the DOM Quality team has partnered with the UCLA Anderson School of Management to study the most efficacious ways to frame and communicate performance based incentives. Understanding the factors that motivate physicians to deliver the highest quality primary care will provide pivotal insights into the successful implementation of performance based programs nationwide. The investigators believe that physicians who receive communication built on behavioral principles will demonstrate more motivation towards and success at meeting national primary care screening guidelines.
This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or asymptomatic for CT, NG, or TV will be evaluated with the Click Sexual Health Test in a Clinical Laboratory Improvement Amendments (CLIA) waived setting. Subjects interested in participating in this study will be assessed for eligibility and asked to give informed consent and assent, if applicable, by the Investigational Review Board (IRB). Only those subjects who meet the inclusion and exclusion criteria may be enrolled in the study.
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.
This investigational study will be conducted to evaluate the performance of the NeuMoDx™ CT/NG Assay on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (collectively referred to as NeuMoDx™ CT/NG Assay test system).
The present trial is a phase I, double-blind, parallel, randomised, and placebo-controlled trial of a chlamydia vaccine CTH522. Sixty-six subjects will be randomly assigned into six cohorts and are to receive four vaccination, in total of 12 trial visits. Cohorts A-D investigates CTH522-CAF01 administered IM in two doses (85 µg and 15 µg). Cohort E investigate CTH522-CAF09b also administered IM in one dose (85 µg). Cohort E is the placebo group. All subjects will receive a TO administration as a boost at Day 140 (4th vaccination). The TO boost will be non-adjuvanted CTH522 (12µg in each eye) or placebo. Nine subjects in each of cohorts A-E will receive the active boost (i.e. CTH522), three subjects will receive the placebo.
This study aims to identify the relationship between genital C. trachomatis and adverse pregnancy outcomes, and investigate whether screening and treatment of genital C. trachomatis in pregnant women can reduce adverse pregnancy outcomes. Approximately 200 pregnant women from Nanhai Hospital of Southern Medical University in Guangzhou, China will be enrolled and randomized to the intervention or control group.
This is a multi-center study with a minimum of three sites in the United States. The study will enroll approximately 1750 female subjects, 14 years of age and older, and will have a study duration of approximately 9 months after enrollment of the first subject. Female subjects seen at the participating sites for any reason will be evaluated for enrollment in this study. All subjects will be managed per standard of care as applicable. Subjects who are enrolled in the study will perform self-collection of a vaginal swab to be tested by Click device and allow the health care provider (HCP) to collect three additional vaginal swabs to be tested by recognized FDA-cleared comparator methods. Subjects will complete the study in a single visit. The primary objective is to assess the performance of the Click device for detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens as compared to Patient Infected Status (PIS) determined by three approved comparator assays using vaginal specimens collected by a qualified HCP in support of obtaining FDA clearance. and a Clinical Laboratory Improvement Amendments (CLIA) Waiver.
This is a randomized controlled trial which will evaluate dual gonorrhea/chlamydia test uptake and other outcomes in men who have sex with men (MSM) in three trial arms - 1) a pay-it-forward testing arm, 2) a pay-what-you-want testing arm, and 3) standard of care arm.