Dataset Information

Clinical trial protocol to evaluate the efficacy of cefixime in the treatment of early syphilis.

ABSTRACT: Background: Syphilis rates have been increasing both in the USA and internationally with incidence higher among men-who-have-sex-with-men and people living with human immunodeficiency virus (HIV) infection. Currently, benzathine penicillin is the recommended treatment for syphilis in all patients. Global shortages and cost increases in benzathine penicillin call for alternative treatment options. This study evaluates the efficacy of oral cefixime for the treatment of early syphilis.

Methods: We are conducting a randomized, multisite, open-label, non-comparative clinical trial in Los Angeles and Oakland, CA. Eligible participants are ??18?years old, with primary, secondary, or early latent syphilis (rapid plasma reagin [RPR] titer ??1:8). Patients with HIV infection must have a viral load ??200 copies/mL and CD4+ T cell count ??350 cells/?L during the past 6?months. Participants are randomized to receive either 2.4?M?IU benzathine penicillin G intramuscularly once or cefixime 400?mg orally twice a day for 10?days. Participants return at 3, 6, and 12?months post-treatment for follow-up RPR serological testing. The primary outcome is the proportion of participants who achieve ??4-fold RPR titer decrease at 3 or 6 months post-treatment.

Discussion: Clinical trials evaluating the efficacy of alternative antibiotics to penicillin are urgently needed.

Trial registration: Clinicaltrials.gov NCT03660488 . Registered on 4 September 2018.

SUBMITTER: Mehta SN

PROVIDER: S-EPMC7725115 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical trial protocol to evaluate the efficacy of cefixime in the treatment of early syphilis.

Mehta Shivani N SN Stafylis Chrysovalantis C Tellalian David M DM Burian Pamela L PL Okada Cliff M CM Millner Carl E CE Mejia Christopher M CM Klausner Jeffrey D JD

Trials 20201209 1

<h4>Background</h4>Syphilis rates have been increasing both in the USA and internationally with incidence higher among men-who-have-sex-with-men and people living with human immunodeficiency virus (HIV) infection. Currently, benzathine penicillin is the recommended treatment for syphilis in all patients. Global shortages and cost increases in benzathine penicillin call for alternative treatment options. This study evaluates the efficacy of oral cefixime for the treatment of early syphilis.<h4>Me ...[more]

PMID: 33298143

Similar Datasets

Project description:BACKGROUND AND OBJECTIVE:A recent striking advance in the treatment of depression has been the finding of rapid antidepressant effects in over 70% of patients with treatment-resistant depression (TRD) using ketamine. However, the potential risk of addiction may limit its clinical use. Recent research revealed that blockade of N-methyl-D-aspartate receptor (NMDAR) dependent bursting activity in the lateral habenula (LHb) could mediate the fast antidepressant effects of ketamine. Further, LHb bursting plays an important role in the pathophysiology of depression that requires both NMDARs and low-voltage-sensitive T-type calcium channels (T-VSCCs). Ethosuximide, which is used to treat absence seizures, is a T-VSCCs inhibitor, may be a novel drug candidate for depression. The objective of this clinical trial is to investigate the efficacy and safety of ethosuximide in patients with TRD. DESIGN:The study is a single center, randomized, double-blind, placebo-controlled, parallel-group, two-stage clinical trial. Forty patients with TRD will be randomly assigned to Group A (treatment group) or Group B (control group). In the first stage ethosuximide or placebo will be given for 2 weeks. In the second stage, escitalopram (or another antidepressant if escitalopram has been used before) will be given for the next 4 weeks for all trial patients to ensure effective treatment. The primary outcome measure is the Montgomery-Åsberg Depression Rating Scale (MADRS) scores. Secondary outcome measures include the Quick Inventory of Depressive Symptomatology-Self Report score, Hamilton Anxiety Rating Scale scores, individual scores of MADRS, and Young Mania Rating Scale scores. All these scales are measured at baseline and at each treatment visit. Two-way repeated measures analysis of variance is used to analyze the study outcomes. DISCUSSION:A statistical analysis plan is employed to enhance the transparency of the clinical trial and reduce the risks of outcome reporting bias and data-driven results.

Project description:BackgroundVitreous floaters are a common ocular condition that affects individuals of all ages. Although vitreous floaters are typically benign, they can significantly impair visual acuity and quality of life. Laser vitreolysis, which uses an Nd: YAG laser to vaporize collagenous vitreous opacities, is increasingly being used as a treatment option. However, there is currently a lack of evidence regarding its efficacy and the appropriate timing of its application. This study aims to evaluate the efficacy and safety of early intervention with YAG laser vitreolysis in treating symptomatic vitreous floaters.MethodsThe present study is a randomized, controlled, double-blind clinical trial. A total of 70 participants with symptomatic floaters for 1 month were prospectively recruited. These participants will be randomly assigned to two groups, with 35 individuals in each group: the early treatment group and the delayed treatment group. Participants assigned to the early treatment group will undergo YAG laser vitreolysis immediately, followed by a sham laser treatment 3 months later. On the other hand, participants assigned to the delayed treatment group will receive a sham laser treatment and then undergo YAG laser vitreolysis 3 months later. The follow-up time points will be 1, 3, 6, and 12 months from randomization. Primary outcomes will be participants' self-reported improvement in visual disturbance on a scale of 1 to 10 and their scores on the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25). Secondary outcomes will be an objective evaluation of the effectiveness of the treatment in reducing vitreous floaters through OCT and fundus photography and tracking any adverse events related to the eyes or overall health.DiscussionThis clinical trial aims to evaluate the effectiveness of YAG laser vitreolysis in treating symptomatic vitreous floaters and assess the safety of performing early intervention with YAG laser vitreolysis.Trial registrationClinicalTrials.gov NCT05800353 . Registered on 10 March 2023.

Project description:IntroductionPrevious research has shown that it is feasible to integrate motivational interviewing techniques with behavioural and psychological interventions for the treatment of obesity. Moreover, these combined interventions have the potential to improve health-related outcomes of people living with obesity (PLWO) and to afford maintenance of behavioural changes over time. In addition, the use of virtual reality (VR) embodiment techniques in the treatment of eating disorders and obesity has promising preliminary effectiveness. The objective of this study is to assess the clinical efficacy of a VR intervention that uses embodiment and body-swapping techniques and has been specifically developed to cover the needs of PLWO.Methods and analysisA randomised control trial will be carried out with an estimated sample of 96 participants with body mass index (BMI)>30. The whole duration of the trial will be 12 months. Participants will be recruited from the external consultations of the Vall d'Hebron University Hospital and be randomly assigned to three groups. The experimental group 1 will engage in a virtual self-conversation using the ConVRself platform, the experimental group 2 will participate in a 'pre-established discourse' provided by the virtual counsellor, who will give psychoeducation advice, and the control group will continue with treatment as usual. Readiness to change, BMI, eating habits and physical activity, psychological well-being, body image satisfaction, quality of life in relation to body image, and weight bias internalisation will be assessed at baseline, post intervention, 1-week and 4-week follow-up. Finally, variables related to adherence and satisfaction with the VR tool will be evaluated for the experimental groups.Ethics and disseminationThis study was approved by the Research Projects Committee of the Vall d'Hebron University Hospital. Findings will be disseminated through peer-reviewed journals, reports to the funding body, conferences and other events for the scientific and clinical community, and the general public.Trial registration numberNCT05094557.

Project description:BackgroundTobacco use continues to be a leading preventable cause of death and disease in the United States, accounting for >480,000 deaths each year. Although treatments for tobacco use are effective for many, there is substantial variability in outcomes, and these approaches are not effective for all individuals seeking to quit smoking cigarettes. New, effective therapeutic approaches are needed to meet the preferences of people who want to stop smoking. Guided imagery (GI) is a mind-body technique that involves the guided visualization of specific mental images, which is enhanced with other sensory modalities and emotions. Preliminary evidence provides initial support for the use of GI as a treatment for cigarette smoking. Meta-analyses have shown that standard treatment for cigarette smoking delivered over the telephone via quitlines is effective. A telephone-based intervention that uses GI might provide another effective treatment option and increase the reach and effectiveness of quitlines.ObjectiveThis study aims to test the efficacy of Be Smoke Free, a telephone-delivered GI treatment for smoking cessation.MethodsThis multisite randomized clinical trial (RCT) will compare a novel telephone-delivered GI tobacco cessation treatment with a standard evidence-based behavioral treatment. The study will be conducted over 5 years. In phase 1, we refined protocols and procedures for the New York State and West Virginia sites for use in the RCT. During phase 2, we will conduct an RCT with 1200 participants: 600 (50%) recruited via quitlines and 600 (50%) recruited via population-based methods. Participants will be randomly assigned to either the GI condition or the behavioral condition; both treatments will be delivered by trained study coaches located at the University of Arizona. Assessments will be conducted at baseline and 3 and 6 months after enrollment by University of Arizona research staff. The primary outcome will be self-reported 30-day point prevalence abstinence 6 months after enrollment. Secondary outcomes include biochemically verified 7-day point prevalence abstinence 6 months after enrollment.ResultsRecruitment in West Virginia and New York began in October 2022. As of March 31, 2023, a total of 242 participants had been enrolled. Follow-up assessments began in November 2022. As of March 31, 2023, of the 118 eligible participants, 97 (82.2%) had completed the 3-month assessment, and 93% (26/28) of eligible participants had completed the 6-month assessment. Biochemical verification and qualitative interviews began in April 2023. Recruitment will continue through 2025 and follow-up assessments through 2026. Primary results are expected to be published in 2027.ConclusionsThe Be Smoke Free study is a first-of-its-kind RCT that incorporates GI into telephone-based tobacco cessation treatment. If successful, Be Smoke Free will have substantial benefits for the long-term health of people who use tobacco across the United States.Trial registrationClinicalTrials.gov NCT05277831; https://clinicaltrials.gov/ct2/show/NCT05277831.International registered report identifier (irrid)PRR1-10.2196/48898.

Dataset Information

Clinical trial protocol to evaluate the efficacy of cefixime in the treatment of early syphilis.

Publications

Clinical trial protocol to evaluate the efficacy of cefixime in the treatment of early syphilis.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets