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Chlamydia Infections clinical trials

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NCT ID: NCT06234943 Not yet recruiting - Clinical trials for Chlamydia Trachomatis Infection

Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia

Start date: January 2024
Phase: N/A
Study type: Interventional

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the first and second most commonly reported sexually transmitted infections (STI) in Canada, respectively, and rates are increasing. While CT and NG can cause a variety of non-specific symptoms, an estimated 77% of CT and 45% of NG cases are asymptomatic. Consequently, many individuals remain undiagnosed, or have delayed diagnosis and consequently miss effective and well-tolerated therapies and may transmit the infection(s) to sexual partners. Untreated CT infection may result in serious sequelae. Also, CT and NG infection are associated with increased risk of acquiring HIV and some cancers. Access to STI testing and treatment are two of the core pillars in the Pan-Canadian Sexually Transmitted and Blood Borne Infections (STBBI) Framework for Action. Currently many Canadians lack a primary care physician and many STI specific clinics are centered in urban areas, further challenging access in rural communities. Increasing access to these core pillars is paramount to reduce the health impact of STBBIs in Canada by 2030. The purpose of this study is to implement and evaluate a novel pilot project including pharmacy-based CT and NG management (including specimen self-collection [pharyngeal, anorectal and/or vaginal swabs, and/or urine sample], assessment, treatment, and linkage to care) by community pharmacists in Nova Scotia.

NCT ID: NCT06216964 Not yet recruiting - Clinical trials for Chlamydia Trachomatis

Time to Clearance of Chlamydia Trachomatis and Neisseria Gonorrhoeae RNA After Treatment: a Prospective Cohort Study

DECHLAGO
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the negativation time of chlamydial and gonococcal PCRs after treatment for urogenital, oropharyngeal and anal infections.

NCT ID: NCT05840159 Recruiting - Clinical trials for Chlamydial Infection

A Study of Doxycycline to Treat Chlamydial Infection

Start date: December 15, 2023
Phase: Phase 4
Study type: Interventional

This is a Phase 4 blinded, randomized, active-controlled, non-inferiority trial. Persons of any gender identity will be eligible. Final evaluable population will include a minimum 596 individuals: 298 persons assigned female sex at birth (AFAB) with confirmed urogenital chlamydia (CT) and 298 persons assigned male at birth (AMAB) with confirmed rectal chlamydia (CT). Approximately 664 participants will be enrolled to achieve a minimum 596 participants who contribute primary outcome data. Randomization will be stratified by study site and sex at birth: 332 persons assigned female sex at birth (AFAB) and 332 persons assigned male sex at birth (AMAB). Participants will be randomized 1:1 to a 3-day regimen of doxycycline or a 7-day regimen of doxycycline. The study blind will be maintained by providing 7 days of identical pre-filled blister packs, one with 3 days of active treatment and 4 days of placebo, and the other with 7 days of active treatment. Participants will be asked to return 28 days after randomization (at day 29), at which time they will be re-tested for chlamydia (CT) using a laboratory-based chlamydia (CT) nucleic acid amplification test (NAAT).

NCT ID: NCT05727033 Not yet recruiting - Gonorrhea Clinical Trials

Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections

FEDE-ITS
Start date: March 2023
Phase: N/A
Study type: Interventional

Project FEDE-ITS will improve the STI knowledge and its treatment, of adolescents in the 1st and 2nd year of compulsory secondary education in the intervention group compared to compared to the control group, and will modify the sexual risk practices and the perception of risky practices of alcohol and other drug use during sex of participants in the intervention group compared to the control group.

NCT ID: NCT05216744 Completed - Clinical trials for Chlamydia Trachomatis Infection

Comparison of Efficacy of Two Combination Regimens for the Neisseria Gonorrhoeae and Chlamydia Coinfection

Start date: July 15, 2021
Phase: Phase 2
Study type: Interventional

The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates.Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. If an injectable cephalosporin is not available, cefixime is the only oral cephalosporin that can be used for gonococcal therapy. Doxycycline was recommended for presumptive treatment of chlamydia in nonpregnant individuals with gonococcal infection. The study is conducted to evaluate the effectiveness of two regimens in combination with doxycycline with cefixime or ceftriaxone.

NCT ID: NCT04955717 Completed - Preterm Birth Clinical Trials

Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences

Start date: February 24, 2021
Phase: N/A
Study type: Interventional

To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs).

NCT ID: NCT04553068 Completed - Clinical trials for Sexually Transmitted Diseases

Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection

EVOGUARD
Start date: October 15, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT and GC infection

NCT ID: NCT04446611 Recruiting - Pregnancy Clinical Trials

Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes

Start date: March 29, 2021
Phase: N/A
Study type: Interventional

This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes. In turn it aims to evaluate the cost per pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness per sexually transmitted infection (STI) and disability-adjusted life-year (DALY) averted. Furthermore, this study will incorporate a vaginal microbiome sub-study aimed to investigate the relationship between the vaginal microbiome and persistent Chlamydial infections in pregnant women. Aim 1 and 2: The intervention includes diagnostic testing at a woman's first antenatal care visit using the Xpert® platform with same-day treatment for Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis infection with either a test-of-cure three weeks post-treatment (arm 1) or a repeat test at 30-34 weeks gestation (arm 2) compared to the standard of care, i.e. syndromic management (arm 3). Aim 3: Case-control study to investigate role vaginal microbiome in STI treatment outcomes

NCT ID: NCT04269434 Completed - Clinical trials for Chlamydia Trachomatis Infection

GonoScreen: Efficacy of Screening STIs in MSM

GonoScreen
Start date: September 21, 2020
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT04244994 Not yet recruiting - Clinical trials for Sexually Transmitted Diseases, Bacterial

Self-taken Penile Meatal Swabs for Chlamydia, Gonorrhoea and Mycoplasma Genitalium Detection

Me-swab
Start date: April 2020
Phase: N/A
Study type: Interventional

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.