Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
-
Randomized Controlled Trial Multicenter Study Clinical Trial
A double-blind, randomized, controlled trial of amphotericin B colloidal dispersion versus amphotericin B for treatment of invasive aspergillosis in immunocompromised patients.
We report a randomized, double-blind, multicenter trial in which amphotericin B colloidal dispersion (ABCD [Amphotec]; 6 mg/kg/day) was compared with amphotericin B (AmB; 1.0-1.5 mg/kg/day) for the treatment of invasive aspergillosis in 174 patients. For evaluable patients in the ABCD and AmB treatment groups, respective rates of therapeutic response (52% vs. 51%; P=1.0), mortality (36% vs. 45%; P=.4), and death due to fungal infection (32% vs. 26%; P=.7) were similar. ⋯ ABCD appears to have equivalent efficacy and superior renal safety, compared with AmB, in the treatment of invasive aspergillosis. However, infusion-related chills and fever occurred more frequently in patients receiving ABCD than in those receiving AmB.
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Ertapenem once daily versus piperacillin-tazobactam 4 times per day for treatment of complicated skin and skin-structure infections in adults: results of a prospective, randomized, double-blind multicenter study.
We conducted a prospective, randomized, double-blind trial comparing ertapenem (1 g once daily) with piperacillin-tazobactam (3.375 g every 6 h) as parenteral treatment for 540 adults with complicated skin and skin-structure infections. The most common diagnoses were skin or soft-tissue abscesses and lower-extremity infections associated with diabetes. The mean duration (+/- standard deviation) of therapy was 9.1+/-3.1 days for ertapenem and 9.8+/-3.3 days for piperacillin-tazobactam. ⋯ The difference in response rates, adjusting for the patients' assigned strata, was -2.0% (95% confidence interval, -10.2% to 6.2%), indicating that the response rates in the 2 treatment groups were equivalent. Cure rates for the 2 treatment groups were similar when compared by stratum, diagnosis, and severity of infection. The frequency and severity of drug-related adverse events were similar in the treatment groups.
-
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A study evaluating the efficacy, safety, and tolerability of ertapenem versus ceftriaxone for the treatment of community-acquired pneumonia in adults.
In a double-blind, multicenter trial, 502 patients hospitalized with community-acquired pneumonia were randomized to receive therapy with either ertapenem or ceftriaxone (for each, 1 g given intravenously once daily). After a minimum of 3 days, therapy could be switched to oral amoxicillin-clavulanate. The median duration of intravenously administered therapy for the 383 clinically evaluable patients was 4 days for both treatment groups; 345 patients (90.1%) had their treatment switched to orally administered therapy. ⋯ Streptococcus pneumoniae was the most commonly isolated pathogen, and high cure rates were observed both for penicillin-susceptible and -nonsusceptible infections in the ertapenem group (28 [87.5%] of 32 patients versus 17 [100%] of 17 patients, respectively). Both treatment regimens were generally well tolerated; the most common drug-related adverse events reported were diarrhea (2.9% versus 2.7%) and nausea (0.8% versus 2.0%) in the ertapenem and ceftriaxone groups, respectively. These results suggest that ertapenem and ceftriaxone therapy have similar efficacy and safety in hospitalized patients with community-acquired pneumonia.
-
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Prospective randomized trial of 10% povidone-iodine versus 0.5% tincture of chlorhexidine as cutaneous antisepsis for prevention of central venous catheter infection.
A multicenter prospective, randomized, controlled trial, with 0.5% tincture of chlorhexidene versus 10% povidone-iodine as cutaneous antisepsis for central venous catheter (CVC) insertion, was conducted for patients in intensive care units. Of 374 patients, 242 had a CVC inserted for >3 days and were used for the primary analysis. Outcomes included catheter-related bacteremia, significant catheter colonization (> or = 15 colony-forming units [cfu]), exit-site infection, serial quantitative exit-site culture (every 72 h), and molecular subtyping of all isolates. ⋯ There was a trend toward fewer exit-site infections in the chlorhexidine group (0 of 125 patients) versus those in the povidone-iodine group (4 of 117 patients; P=.053). Results of an intention-to-treat analysis were unchanged from the primary analysis. No difference was demonstrable between 0.5% tincture of chlorhexidine and 10% povidone-iodine when used for cutaneous antisepsis for CVC insertion in patients in the intensive care unit.
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Diagnosis and management of increased intracranial pressure in patients with AIDS and cryptococcal meningitis. The NIAID Mycoses Study Group and AIDS Cooperative Treatment Groups.
This study was undertaken to characterize the laboratory and clinical course of patients with AIDS and cryptococcal meningitis who had normal or elevated cerebrospinal fluid (CSF) pressure. Data were obtained retrospectively from a randomized multicenter quasifactorial phase III study comparing amphotericin B with or without flucytosine in primary treatment of cryptococcal meningitis. CSF pressure was measured before treatment and at 2 weeks. ⋯ After receiving antifungal therapy, those patients whose CSF pressure was reduced by >10 mm or did not change had more frequent clinical response at 2 weeks than did those whose pressure increased >10 mm (P<.001). Patients with pretreatment opening pressure <250 mm H2O had increased short-term survival compared with those with higher pressure. We recommend that opening pressures >/=250 mm H2O be treated with large-volume CSF drainage.