View clinical trials related to Infections.
Filter by:The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections. It was planned that LYS228 exposure across patients with varying renal function would be evaluated during the study to confirm that LYS228 concentrations are predicted to be adequate to treat the patient population. It was planned that the PK exposure of the initial 8 patients would be analyzed. PK analysis was not conducted as per protocol the first analysis required 8 patients.
This is a randomized, double-blinded, placebo-controlled, non-inferiority multicenter clinical trial of azithromycin vs. placebo in adults presenting as outpatients with suspect Lower Respiratory Tract Infection (LRTI) and a Procalcitonin (PCT) level of < / = 0.25 ng/mL, as a strategy for reducing antibiotic prescriptions. The study is designed to compare the efficacy of azithromycin versus placebo on Day 5 (i.e., after 4 days of treatment) in subjects with suspect LRTI and PCT levels of < / = 0.25 ng/mL at enrollment using a non-inferiority approach. The study will recruit potential subjects 18 years of age or older who are suspected to have LRTI. The enrollment cap will be 840 participants, for the goal of approximately 674 randomized participants who will be randomized 1:1 to receive oral azithromycin or placebo for five days. Randomized subjects will have efficacy measured from the time of the first dose of study drug (Day 1) through approximately Day 28. The Primary Objective is to compare the efficacy of azithromycin versus placebo on Day 5 (i.e., after 4 days of treatment) in subjects with suspect LRTI and PCT levels of < / = 0.25 ng/mL at enrollment using a non-inferiority approach.
Due to the emergence of multidrug-resistant micro-organisms in patients with bone and joint infection (BJI), the prescription of off-labeled antibiotics seem to be more and more common as part of routine care. These new antibiotics are, however, more expensive, and there are no precise data in France regarding the volume and cost of such off-label prescriptions in hospital, in the post-acute care structures, and in the outpatient setting. The objective of this study is to estimate the cost of using these antibiotics over 2 years for patients in a reference center for the management of complex bone and joint infection (CRIOAc)
This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent development of sensorineural hearing loss (SNHL) in infants with asymptomatic congenital cytomegalovirus (CMV) infection. The trial will be conducted in two phases - screening of newborns to identify eligible subjects, and treatment of those newborns who have confirmed CMV infection at birth but without outward manifestations of congenital CMV infection. 229 newborns with confirmed CMV infection but without baseline SNHL and who meet all inclusion/exclusion criteria will be enrolled into the treatment phase. Study duration is 5 years. Primary objective of this study is to estimate the proportion of subjects with asymptomatic congenital CMV infection who, following treatment with 4 months of oral valganciclovir, develop SNHL by 6 months of life.
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa respiratory tract infection or colonization.
Infections requiring intravenous antimicrobial therapy are very common events in patients with advanced cancer. Nevertheless, these patients frequently present vascular damages becoming extremely difficult to access and maintain intravenous route for hydration and nutritional support. In this context, the subcutaneous route could be implemented as an alternative route for replacement of fluids, electrolytes and drugs. Few studies have evaluated the possibility of using the subcutaneous route for treatment of infections though. Patients in palliative care often have infections caused by multidrug resistant bacterial such as beta-lactamase producing bacteria. In this context, we hypothesize Ertapenem subcutaneously is not inferior to the same drug intravenously for the treatment of urinary infections in patients on oncologic palliative care. A non-inferiority clinical trial would be adequate and could provide stronger evidence on the possibility of this alternative route for antibiotic therapy in urinary tract infections, with important advantages such as greater convenience of use.
The aim of this study is to evaluate the possibility to repropose marketed drugs as antiviral ones, based on their ability to reverse the transcriptomic signature of the infected cells. This strategy has to be considered is the context of emerging viral diseases and of increase of resistance to antivirals. Concerning infection by Influenza viruses, the main drugs were identified and evaluated on in vitro and in vivo models: diltiazem. Therefore, it will be assess the efficacy of these the drug, compared to placebo, to treat severe flu.
This study will estimate the cumulative incidence of Zika infection at the end of the first epidemic in the French West Indies in a sample of patients followed for HIV infection.
Pilot study to determine feasibility for treating patients with two chronic inflammatory conditions of the urinary bladder: chronic interstitial cystitis and recurrent urinary tract infections using a standardized hyperbaric oxygen treatment plan. Presently there are no good treatments for these conditions and hyperbaric oxygen may be a safe and readily accessible therapy as it has proven successful an another type of chronic inflammatory condition of the urinary bladder known as "radiation cystitis". The study will determine if patients will consider this an acceptable treatment for their conditions and that it is well tolerated.
The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG test on treatment of female patients in the emergency department or urgent care setting with possible STIs.