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Syphilis clinical trials

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NCT ID: NCT03418441 Recruiting - Meningitis Clinical Trials

Central Nervous System Infections in Denmark

DASGIB
Start date: January 1, 2015
Phase:
Study type: Observational

The Danish Study Group of Infections of the Brain is a collaboration between all departments of infectious diseases in Denmark. The investigators aim to monitor epidemiological trends in central nervous system (CNS) infections by a prospective registration of clinical characteristics and outcome of all adult (>17 years of age) patients with community-acquired CNS infections diagnosed and/or treated at departments of infectious diseases in Denmark since 1st of January 2015.

NCT ID: NCT03310424 Active, not recruiting - Syphilis Clinical Trials

Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum

Start date: October 27, 2017
Phase:
Study type: Observational

Syphilis is an important sexually transmitted infection. There has been an epidemic of syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a generalised illness often accompanied by rash. Studies on the pathogenesis of syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches using molecular tests allow the immune response of the patient to infection to be measured directly from a swab of a genital ulcer or rash and/or a blood sample and also allow the whole genetic sequence of the bacteria to be obtained from a swab. In this study the investigators will collect swabs from ulcers or rashes and a blood sample from patients with syphilis and measure both the response of the patient immune system and the genetic sequence of the bacteria. Patients will be enrolled at sexual health clinics in the United Kingdom. Patients will receive standard medical care including standard treatment for syphilis in line with national guidelines. Standard management already includes collection of a swab and a blood sample. For this study an additional swab sample and an additional 5ml of blood will be collected for use in this research project. By better understanding host immune system responds to infection with syphilis the studies aims to gain better insights in to the pathogenesis of this important sexually transmitted disease.

NCT ID: NCT03156751 Completed - Diagnoses Disease Clinical Trials

Feasibility of Introducing an Onsite Test for Syphilis in the Package of Antenatal Care in Burkina Faso

Start date: May 1, 2013
Phase: N/A
Study type: Observational

This study used a pre post intervention mixed methods quasi-experimental design with a group of health facilities offering antenatal care (ANC) services (primary health centers in rural area) as the sampling units. This study was conducted in three phases, which consisted of a situational analysis using qualitative methods (Phase 1), selecting an appropriate test through evaluating 4 candidate tests and the participatory design and implementation of an intervention that included onsite training, provision of supplies and medicines, quality control and supervision (Phase 2), and an evaluation combining review of record tools, interviews, time motion study and estimating incremental costs (Phase 3). The conceptual framework draws on multilevel assessment (MLA), policy triangle framework, Medical Research Council framework for designing complex interventions and the Normalization Process Model (NPM). Methods included document review, seventy five interviews were conducted with health providers, district managers, facility managers, traditional healers, pregnant women, community health workers, and Non-Governmental Organizations (NGO) managers in phase I and fourteen in phase III, non-participant observation, time-motion study, incremental cost analysis, and sensitivity, specificity and ease of use analysis of four candidate point-of care tests. Data were collected between 2012 and 2014. Qualitative data were analyzed through thematic analysis supported by Nvivo software. Quantitative data were analyzed through descriptive statistics such as frequency, mean and median supported by SPSS. Phase I identified barriers to implementation and uptake of syphilis testing at health provider and community levels. The most important barriers at provider level included fragmentation of services, poor communication between health workers and clients, failure to prescribe syphilis test, and low awareness of syphilis burden. Cost of testing, distance to laboratory and lack of knowledge about syphilis were identified as barriers at community level. Phase II: Alere DetermineTM Syphilis was the most sensitive of the four point-of-care tests evaluated. The components of the intervention were successfully implemented in the selected health facilities. Overall, phase III showed that it is feasible and acceptable to introduce a point of care test for syphilis in antenatal care services at primary health care level using the available staff. The findings suggested that an intervention that introduces point of care test for syphilis at antenatal care services is feasible, acceptable, and of comparable costs to HIV screening in pregnancy. Nonetheless, instructions and supervision need to be clearer to achieve optimal levels of screening and quality control, and barriers identified by health workers need to be overcome. The point-of care test for syphilis is likely to be acceptable by health workers as a routine service and incorporated as a normal practice in Burkina Faso context.

NCT ID: NCT02884115 Recruiting - Syphilis Clinical Trials

Serological Response to Retreatment of Serofast Early Syphilis Cases With Benzathine Penicillin

Start date: August 2016
Phase: Phase 4
Study type: Interventional

A continuing challenge to determining the response to treatment of early syphilis (primary, secondary, early latent syphilis) is exemplified by the substantial proportion of patients who fail to achieve serological cure and remain serofast. Although retreatment is often done in clinical practice, optimal management remains uncertain due to the paucity of data regarding serological response to retreatment and long-term outcomes. Furthermore, the investigators cannot rule out that the gradually increasing seroreversion/serological cure rates may have been due to the natural decline in rapid plasma regain (RPR) titers after initial therapy, rather than due to the additional dose of benzathine penicillin. Thus, the investigators would like to conduct a clinical trial to compare the serological response rates of serofast early syphilis cases retreated with three doses benzathine penicillin and absence of any retreatment (control group).

NCT ID: NCT02871505 Recruiting - Syphilis Clinical Trials

The Association Between Molecular Typing of Treponema Pallidum and Treatment Efficacy and Clinical Findings

Start date: August 2016
Phase: Phase 4
Study type: Interventional

The investigators compare the treatment results and clicical presentations of different Molecular subtyping of Treponema pallidum

NCT ID: NCT02864550 Active, not recruiting - Syphilis Clinical Trials

Oral Doxycycline for the Prevention of Syphilis in Men Who Have Sex With Men (DaDHS)

Start date: August 15, 2019
Phase: Phase 4
Study type: Interventional

Syphilis is a sexually transmitted infection (STI) disproportionately affecting gay, bisexual and other men who have sex with men (gbMSM), with the potential for significant sequelae - particularly in those who are Human Immunodeficiency Virus (HIV)-positive. Rising rates of this STI have prompted a search for novel prevention solutions. A recent pilot study of daily doxycycline prophylaxis demonstrated promise as a novel STI prevention tool. This innovative approach to STI prevention has solid clinical precedent, both from the HIV pre-exposure prophylaxis (PrEP) literature, as well as doxycycline's use as prophylaxis for other infections. The overarching goal of this project is to determine whether the daily use of doxycycline is an efficacious and acceptable intervention for syphilis prevention in high-risk, HIV-positive gbMSM.

NCT ID: NCT02857959 Recruiting - Syphilis Clinical Trials

One Dose Versus Three Weekly Doses of Benzathine Penicillin G for Patients With Early Syphilis

Start date: August 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to observe the serological response to 1 or 3 weekly doses of benzathine penicillin G in patients with early syphilis.

NCT ID: NCT02844634 Active, not recruiting - HIV Clinical Trials

Tenofovir/Emtricitabine With Doxycycline for Combination HIV and Syphilis Pre-exposure Prophylaxis in HIV-negative MSM

DuDHS
Start date: May 15, 2018
Phase: Phase 4
Study type: Interventional

Men who have sex with men remain at high risk for HIV infection. Targeting prevention interventions to MSM at highest risk of seroconversion is an important goal of combination prevention interventions. Antecedent diagnosis of another sexually transmitted infection (STI), particularly syphilis, may serve as an entry point for biomedical prevention as these individuals are at highest risk for incident HIV. The use of the antiretroviral combination of tenofovir/emtricitabine has been shown to be associated with an overall 44% reduction in HIV acquisition in high-risk MSM when taken daily as PrEP. In those individuals with detectable drug levels, the benefit was as high as 90% risk reduction. In real-world evaluations of PrEP, high-risk sexual behaviour may continue as evidenced by high rates of intercurrent sexually transmitted infections. As such, biomedical interventions that may offer additional reduction in acquisition of common sexually transmitted infections should also be evaluated. Recently a small pilot study has demonstrated potential benefit from a similar strategy for syphilis prevention. In this study 30 MSM were randomized to receive either 100mg doxycycline once daily or contingency management strategies linked to remaining free of sexually transmitted diseases at progressive study visits. Overall, those receiving doxycycline were significantly less likely to be diagnosed with any STI during followup than those in the comparator arm. The investigators therefore propose to undertake a pilot study to evaluate the feasibility of using both tenofovir/emtricitabine and doxycycline (immediate or deferred use) for pre-exposure prophylaxis amongst HIV-negative MSM with recent history of syphilis infection in Vancouver, Canada.

NCT ID: NCT02752152 Completed - Clinical trials for HIV, Hepatitis B, Hepatitis C and Syphilis Infections

Counseling and Reminders for Regular HIV and STIs Screening

Napneung-1
Start date: December 9, 2015
Phase: N/A
Study type: Interventional

Counseling intervention: Primary objective: to evaluate and compare, in at-risk populations, the efficacy of three different counseling methods in terms of propensity to come back for a HIV re-test. Secondary objectives: to evaluate and compare the efficacy of the counseling methods in terms of reported risk behavior and HIV knowledge as well as their acceptability and cost-effectiveness; describe the distribution of duration from HIV primary infection to detection; and estimate the prevalence of chronic hepatitis B and C, and syphilis in HIV-uninfected participants of targeted populations. Reminder intervention Primary objective: to evaluate and compare, in at-risk individuals who require frequent testing, the efficacy of reminders in terms of propensity to come back for a HIV re-test within 7 months. Secondary objective: to assess the cost-effectiveness of reminders. The interim analyses have shown that that some strategies are better than the others and the Advisory Committee recommended to use only the most efficient strategies (Computer assisted counseling and Scheduling an appointment and sending reminder to clients). In addition, CD4 cell count normal ranges in 30 HIV uninfected individuals in Thailand will be assessed. Transient elastometry (FibroScan) will be used to assess liver fibrosis in participants with and without viral hepatitis.

NCT ID: NCT02611765 Completed - Syphilis Clinical Trials

Syphilis Response to Higher Penicillin Dosage: The 2.4 Versus 7.2 Study

Start date: September 2008
Phase: Phase 4
Study type: Interventional

Syphilis remains a significant health problem worldwide, with an estimated 10.6 million new cases per year. Due to shared transmission route and risk factors, co-infection with syphilis and Human Immunodeficiency Virus (HIV) is not uncommon. Several studies have evaluated the response to syphilis treatment in HIV-infected patients. They support the claim that patients with HIV have a slower decrease in syphilis antibody titers, and that they may progress to neurosyphilis in earlier stages. The Center for Disease Control and Prevention's Sexually Transmitted Disease Treatment Guidelines has advocated treating HIV-infected patients who have primary, secondary syphilis or early latent syphilis with the same doses of penicillin as for HIV-uninfected patients (single dose of 2.4 million units of benzathine penicillin G). The investigators designed a randomized controlled trial in order to compare the efficacy of three- versus single-dosed regimens of intramuscular benzathine penicillin G (BPG) for the treatment of early syphilis in HIV-infected patients.