About 86,400 results

Expanded Access Study of Exebacase in COVID-19 Patients With Persistent MRSA Bacteremia

Sep 10th, 2021 - This is an open-label, expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI), including right-sided endocarditis (R-IE), who are hospitalized with coronavirus disease 2019 (COVID-19). Patients with left-sided endocarditis (L-IE) are excluded. Patients...

Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection

Sep 10th, 2021 - This is a phase 4, randomized, open-label, multicenter trial to evaluate the efficacy of a single injected dose of Benzathine Penicillin G (BPG) 2.4 MU (Arm 1) compared to three successive weekly injected doses of BPG 2.4 MU (Arm 2) for treatment of early syphilis in human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects. The study will enroll 560 adults (to achieve 420 evaluab...

Auranofin for Giardia Protozoa

Sep 10th, 2021 - This is a phase IIa, randomized, placebo-controlled, single-blinded superiority treatment study in males and non-pregnant females, 18 to 65 years of age who are in good health. This study is designed to compare placebo to once daily doses of 6mg auranofin for adults with amebiasis or giardiasis. A sample size of 68 subjects enrolled with amebiasis (34 per arm) and 68 with giardiasis (34 per arm...

Quality of Life and Patient-centered Outcomes After ICU Admission for COVID-19

Sep 10th, 2021 - Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the Intensive Care Unit (ICU), are susceptible to development of various functional sequelae, increased risk of chronic diseases, increased mortality rates and existence of relevant impacts on their quality of life in the months and years that follow the ICU admission. The present study aims to assess the determin...

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

Sep 10th, 2021 - Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure. Talquetamab is a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell...

Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis

Sep 10th, 2021 - This is a randomised, double-blind clinical investigation to evaluate the efficacy and safety of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis. The study will be conducted at one site in Scotland, United Kingdom. The study population will consist of approximately 96 female subjects.

The Containing Coronavirus Disease 19 (COVID-19) Trial

Sep 10th, 2021 - Participants with COVID-19 will be identified from lists of patients with positive SARS-CoV-2 PCR that is obtained daily from clinical laboratories, at COVID-19 outpatient and hospital clinics, or the Emergency Rooms in Chile. After telephonically pre-screening eligibility of the index case and his/her household, and participants providing informed consent, households will be randomized 1:1 to ...

Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acquired Pneumonia

Sep 10th, 2021 - Coronavirus-2019 disease (COVID-19) and community-acquired pneumonia are significant problems of modern medicine. Pneumonia is the most common severe complication of COVID-19. But at the same time, COVID-19 is not the only cause of community-acquired pneumonia. Moreover, pneumonia is only one of the numerous possible severe complications of COVID-19. Medical centers specialized for the hospital...

Anthrax AV7909 Liquid vs Lyophilized

Sep 10th, 2021 - This is a randomized, parallel-group, double-blind, Phase 1 study designed to assess safety, tolerability and immunogenicity of 2 formulations of adjuvanted anthrax vaccine (AV7909), lyophilized and liquid. Forty healthy young adults, 18 to 45 years old, inclusive, who meet all eligibility criteria, will be randomly allocated to one of two study groups in a 1:1 ratio: 20 will receive AV7909 as ...

Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)

Sep 10th, 2021 - This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody re...

DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia

Sep 10th, 2021 - This is a Phase 2b clinical study, multicenter, randomized, open-label, assessor-blinded, superiority study. The study will compare dalbavancin to standard of care antibiotic therapy for the completion of therapy in patients with complicated bacteremia or right-sided native valve Infective Endocarditis (IE) caused by S. aureus who have cleared their baseline bacteremia. Approximately 200 subjec...

Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older

Sep 10th, 2021 - An individual's immune profile changes with age, and can sometimes be involved in the development of certain diseases such as infections or cancers, in a process called immunosenescence. Some data tend to show that there is a link between this immune profile and geriatric fragility (autonomy, difficulties with walking, memory, undernutrition, co-morbidities, depression). The aim of this study i...

Efficacy and Safety of MK-1654 in Infants (MK-1654-004)

Sep 10th, 2021 - The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of MK-1654 in healthy pre-term and full-term infants. It is hypothesized that MK-1654 will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to plac...

Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB

Sep 10th, 2021 - Purpose: Worldwide over 15 million persons live with active TB. While the prevalence of latent TB is very high, only disease, and not latent infection, is treated in most high burdened countries. A rapid triage test for detection of active TB, which can identify symptomatic individuals who require confirmatory diagnostic investigation, is a global priority for TB control. A rapid triage test ca...

Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

Sep 10th, 2021 - Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.

SARS-Cov-2 (COVID-19) Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial

Sep 10th, 2021 - Investigators have demonstrated the in vitro viridical efficacy of both Listerine Antiseptic® and 1% dilute baby shampoo solution, a commonly used nasal rinse, against a SARS-CoV-2 surrogate and Meister et al. have similar findings with SARS-CoV-2. With an urgent need to expand the armamentarium of widely available, low-cost interventions, that are safe for repeated human use and reduce viral t...

Suppression Of Bacterial Vaginosis (BV) [SUBVert]

Sep 10th, 2021 - This is a Phase II randomized, double-blind, placebo-controlled study screening approximately 600 adult females, aged 18-55, with a goal to enroll approximately 250 participants to achieve 200 evaluable participants at the test of cure (TOC) visit. The study is designed to determine the clinical efficacy of an investigational product (IP), TOL-463 Insert, in suppressing Recurrent Bacterial Vagi...

Evaluating the Safety and Immunogenicity of an HIV-1 gp41 MPER-656 Liposome Vaccine in Healthy, HIV-uninfected Adult Participants

Sep 10th, 2021 - This study will evaluate the safety and immunogenicity of an HIV-1 gp41 MPER-656 liposome vaccine in healthy, HIV-uninfected adults. Participants will be randomly assigned to four groups. Participants in Group 1 (Treatment 1) will receive 500 mcg of MPER-656 liposome vaccine at Months 0, 2, and 6. Participants in Group 1 (Control 1) will receive placebo at Months 0, 2, and 6. Participants in Gr...

Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

Sep 10th, 2021 - This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).

Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Sep 10th, 2021 - This study aims to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in adult/adolescent and pediatric patients with uncomplicated P. falciparum malaria. There is unmet medical need for anti-malarial treatment with new mechanism of action to reduce probabi...