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2.
Clin Infect Dis ; 43(4): 411-20, 2006 Aug 15.
Artículo en Inglés | MEDLINE | ID: mdl-16838228

RESUMEN

BACKGROUND: Current antibiotic therapies for Clostridium difficile-associated diarrhea have limitations, including progression to severe disease, recurrent C. difficile-associated diarrhea, and selection for nosocomial pathogens. Tolevamer, a soluble, high-molecular weight, anionic polymer that binds C. difficile toxins A and B is a unique nonantibiotic treatment option. METHODS: In this 3-arm, multicenter, randomized, double-blind, active-controlled, parallel-design phase II study, patients with mild to moderately severe C. difficile-associated diarrhea were randomized to receive 3 g of tolevamer per day (n = 97), 6 g of tolevamer per day (n = 95), or 500 mg of vancomycin per day (n = 97). The primary efficacy parameter was time to resolution of diarrhea, defined as the first day of 2 consecutive days when the patient had hard or formed stools (any number) or < or = 2 stools of loose or watery consistency. RESULTS: In the per-protocol study population, resolution of diarrhea was achieved in 48 (67%) of 72 patients receiving 3 g of tolevamer per day (median time to resolution of diarrhea, 4.0 days; 95% confidence interval, 2.0-6.0 days), in 58 (83%) of 70 patients receiving 6 g of tolevamer per day (median time to resolution of diarrhea, 2.5 days; 95% confidence interval, 2.0-3.0 days), and in 73 (91%) of 80 patients receiving vancomycin (median time to resolution of diarrhea, 2.0 days; 95% confidence interval, 1.0-3.0 days). Tolevamer administered at a dosage of 6 g per day was found to be noninferior to vancomycin administered at a dosage of 500 mg per day with regard to time to resolution of diarrhea (P = .02) and was associated with a trend toward a lower recurrence rate. Tolevamer was well tolerated but was associated with an increased risk of hypokalemia. CONCLUSIONS: Tolevamer, a novel polystyrene binder of C. difficile toxins A and B, effectively treats mild to moderate C. difficile diarrhea and merits further clinical development.


Asunto(s)
Clostridioides difficile , Enterocolitis Seudomembranosa/tratamiento farmacológico , Iones/uso terapéutico , Polímeros/uso terapéutico , Poliestirenos/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Antiinfecciosos/uso terapéutico , Proteínas Bacterianas/metabolismo , Toxinas Bacterianas/metabolismo , Diarrea/tratamiento farmacológico , Diarrea/microbiología , Método Doble Ciego , Enterocolitis Seudomembranosa/microbiología , Enterotoxinas/metabolismo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Ácidos Sulfónicos , Vancomicina/uso terapéutico
3.
Curr Opin Mol Ther ; 8(5): 455-60, 2006 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-17078388

RESUMEN

Inhibitex Inc is investigating tefibazumab, a humanized monoclonal antibody specific for the fibrin-binding surface epitope clumping factor A protein (expressed on the surface of most Staphylococcus aureus strains), for the potential intravenous prevention and/or treatment of S aureus infections. In June 2006, Inhibitex was seeking to outlicense certain development rights to the drug. Pending the outcome of partnering discussions, Inhibitex suspended the initiation of any additional clinical trials of tefibazumab. Preclinical in vivo studies were ongoing at that time.


Asunto(s)
Anticuerpos Monoclonales/uso terapéutico , Proteínas Bacterianas/inmunología , Coagulasa/inmunología , Infecciones Estafilocócicas/prevención & control , Staphylococcus aureus/inmunología , Adhesinas Bacterianas , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales/farmacocinética , Ensayos Clínicos Fase II como Asunto , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Infecciones Estafilocócicas/microbiología
5.
Infect Control Hosp Epidemiol ; 34(5): 479-86, 2013 May.
Artículo en Inglés | MEDLINE | ID: mdl-23571364

RESUMEN

OBJECTIVE. Healthcare-acquired infections (HAIs) cause substantial patient morbidity and mortality. Items in the environment harbor microorganisms that may contribute to HAIs. Reduction in surface bioburden may be an effective strategy to reduce HAIs. The inherent biocidal properties of copper surfaces offer a theoretical advantage to conventional cleaning, as the effect is continuous rather than episodic. We sought to determine whether placement of copper alloy-surfaced objects in an intensive care unit (ICU) reduced the risk of HAI. DESIGN. Intention-to-treat randomized control trial between July 12, 2010, and June 14, 2011. SETTINg. The ICUs of 3 hospitals. PATIENTS. Patients presenting for admission to the ICU. METHODS. Patients were randomly placed in available rooms with or without copper alloy surfaces, and the rates of incident HAI and/or colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room were compared. RESULTS. The rate of HAI and/or MRSA or VRE colonization in ICU rooms with copper alloy surfaces was significantly lower than that in standard ICU rooms (0.071 vs 0.123; P = .020). For HAI only, the rate was reduced from 0.081 to 0.034 (P = .013). CONCLUSIONs. Patients cared for in ICU rooms with copper alloy surfaces had a significantly lower rate of incident HAI and/or colonization with MRSA or VRE than did patients treated in standard rooms. Additional studies are needed to determine the clinical effect of copper alloy surfaces in additional patient populations and settings.


Asunto(s)
Cobre , Infección Hospitalaria/epidemiología , Desinfectantes , Fómites/microbiología , Unidades de Cuidados Intensivos , Infecciones Estafilocócicas/epidemiología , Adulto , Anciano , Recuento de Colonia Microbiana , Cobre/farmacología , Infección Hospitalaria/prevención & control , Desinfectantes/farmacología , Desinfección/métodos , Enterococcus , Microbiología Ambiental , Femenino , Infecciones por Bacterias Grampositivas/epidemiología , Infecciones por Bacterias Grampositivas/prevención & control , Humanos , Incidencia , Análisis de Intención de Tratar , Masculino , Staphylococcus aureus Resistente a Meticilina , Persona de Mediana Edad , Habitaciones de Pacientes , Infecciones Estafilocócicas/prevención & control , Resistencia a la Vancomicina
11.
Ther Clin Risk Manag ; 3(6): 1143-52, 2007 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-18516271

RESUMEN

Coagulase-negative staphylococci (CNS) are a heterogenous group of Gram-positive cocci that are widespread commensals among mammalia. Unlike their coagulase-positive counterpart, Staphylococcus aureus, CNS produce few virulence patterns and normally refrain from invading tissue. Yet, not only can CNS cause infections in normal host tissue, but modern medicine has also seen their rise as opportunists that display adherence to medical device materials to produce a protective biofilm. CNS have historically been more resistant to antimicrobials, including the beta-lactam antibiotics, than S. aureus and some hospitals reveal rates of oxacillin resistance in CNS approaching 90%. Cross resistance to non-beta-lactam agents has been a recurrent theme over the past 40 years in the CNS. Thus, there has been a pressing need for newer antimicrobial agents with good antistaphylococcal activity. Those new agents tend to have excellent antistaphylococcal activity include daptomycin, linezolid, oritavancin, telavancin, tigecycline, dalbavancin, new quinolones, and ceftibiprole, several of which have unique mechanisms of action. The MIC90 for these new compounds typically ranges from 0.5-4 mug/mL. Staphylococcal biofilm formation is quite common in CNS infections and markedly increases the MIC for most older antimicrobials. Several of the newer agents offer some promise of penetration of biofilm to inhibit or kill adherent staphylococci. CNS will likely remain a major cause of infections in the modern age, evolve further antimicrobial resistance mechanisms, and require development of newer antimicrobials for curative therapy.

12.
Antimicrob Agents Chemother ; 50(8): 2751-5, 2006 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-16870768

RESUMEN

Tefibazumab (Aurexis), a humanized monoclonal antibody that binds to the surface-expressed adhesion protein clumping factor A, is under development as adjunctive therapy for serious Staphylococcus aureus infections. Sixty patients with documented S. aureus bacteremia (SAB) were randomized and received either tefibazumab at 20 mg/kg of body weight as a single infusion or a placebo in addition to an antibiotic(s). The primary objective of the study was determining safety and pharmacokinetics. An additional objective was to assess activity by a composite clinical end point (CCE). Baseline characteristics were evenly matched between groups. Seventy percent of infections were healthcare associated, and 57% had an SAB-related complication at baseline. There were no differences between the treatment groups in overall adverse clinical events or alterations in laboratory values. Two patients developed serious adverse events that were at least possibly related to tefibazumab; one hypersensitivity reaction was considered definitely related. The tefibazumab plasma half-life was 18 days. Mean plasma levels were <100 microg/ml by day 14. A CCE occurred in six patients (four placebo and two tefibazumab patients) and included five deaths (four placebo and one tefibazumab patient). Progression in the severity of sepsis occurred in four placebo and no tefibazumab patients. Tefibazumab was well tolerated, with a safety profile similar to those of other monoclonal antibodies. Additional trials are warranted to address the dosing range and efficacy of tefibazumab.


Asunto(s)
Anticuerpos Monoclonales/farmacocinética , Bacteriemia/tratamiento farmacológico , Infecciones Estafilocócicas/terapia , Staphylococcus aureus/efectos de los fármacos , Adulto , Anciano , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales/uso terapéutico , Área Bajo la Curva , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad
13.
South Med J ; 96(9): 900-5, 2003 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-14513988

RESUMEN

Necrotizing skin and soft tissue infections are caused by many different bacteria, are frequently polymicrobial, and may have a deceptively innocent early clinical presentation. Clostridial and nonclostridial necrotizing infections are frequently similar in their early presentation. The initial presentation of these infections can be insidious, which results in delay in diagnosis and the start of therapy. The clinician must use sound medical principles of clinical history and meticulous examination in each patient, combined with constant suspicion, to establish a timely diagnosis. This group of infectious diseases is associated with frequent morbidity and significant mortality rates, which increase with any delay in the diagnosis and the initiation of medical and surgical therapy. Also associated with these necrotizing infections is an excessive index of litigation. This review is intended as a guide for the clinician in making an early diagnosis of any necrotizing skin and soft tissue infection and initiating effective medical and surgical therapy.


Asunto(s)
Necrosis , Enfermedades Cutáneas Infecciosas/diagnóstico , Enfermedades Cutáneas Infecciosas/terapia , Infecciones de los Tejidos Blandos/diagnóstico , Infecciones de los Tejidos Blandos/terapia , Humanos , Guías de Práctica Clínica como Asunto , Enfermedades Cutáneas Infecciosas/microbiología , Infecciones de los Tejidos Blandos/microbiología , Factores de Tiempo
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