Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
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Multicenter Study
Clinical significance of nephrotoxicity in patients treated with amphotericin B for suspected or proven aspergillosis.
The records of 239 immunosuppressed patients receiving amphotericin B for suspected or proven aspergillosis were reviewed to determine rates of nephrotoxicity, dialysis, and fatality. The mean and median durations of treatment were 20.4 and 15.0 days, respectively. ⋯ Use of hemodialysis (HR, 3. 089; P<.001), duration of amphotericin B use (HR, 1.03 per day; P=. 015), and use of nephrotoxic agents (HR, 1.96; P=.017) were associated with greater risk of death, whereas patients undergoing solid organ transplantation were at lowest risk (HR, 0.46; P=.002). These data indicate that elevated creatinine levels during amphotericin B treatment are associated with a substantial risk for hemodialysis and a higher mortality rate, but the risks vary in different patient groups.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Once weekly azithromycin therapy for prevention of Mycobacterium avium complex infection in patients with AIDS: a randomized, double-blind, placebo-controlled multicenter trial.
We conducted a randomized, double-blind, placebo-controlled multicenter trial of azithromycin (1,200 mg once weekly) for the prevention of Mycobacterium avium complex (MAC) infection in patients with AIDS and a CD4 cell count of < 100/mm3. In an intent-to-treat analysis through the end of therapy plus 30 days, nine (10.6%) of 85 azithromycin recipients and 22 (24.7%) of 89 placebo recipients developed MAC infection (hazard ratio, 0.34; P = .004). There was no difference in the ranges of minimal inhibitory concentrations of either clarithromycin or azithromycin for the five breakthrough (first) MAC isolates from the azithromycin group and the 18 breakthrough MAC isolates from the placebo group. ⋯ Episodes of non-MAC bacterial infection per 100 patient years occurred in 43 azithromycin recipients and 88 placebo recipients (relative risk, 0.49; 95% confidence interval, 0.33-0.73). The most common toxic effect noted during the study was gastrointestinal, reported by 78.9% of azithromycin recipients and 27.5% of placebo recipients. Azithromycin given once weekly is safe and effective in preventing disseminated MAC infection, death due to MAC infection, and respiratory tract infections in patients with AIDS and CD4 cell counts of < 100/mm3.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Amphotericin B lipid complex compared with amphotericin B in the treatment of cryptococcal meningitis in patients with AIDS.
The study objective was to obtain preliminary information regarding the safety and efficacy of amphotericin B (AmB) lipid complex (ABLC) in the treatment of AIDS-associated cryptococcal meningitis. Of 55 patients randomly assigned to 6 weeks of therapy with ABLC (1.2-5.0 mg/[kg.d], with ascending doses for three sequential cohorts) or AmB (0.7-1.2 mg/[kg.d]), 46 received > or = 12 doses. Transfusion requirements, mean decreases in hemoglobin level, and mean increases in creatinine level were significantly greater with AmB than with ABLC. ⋯ Of those receiving > or = 12 doses of ABLC, cultures converted to negative for 8 (42%), were undeterminable for 3 (16%), and remained positive for 8 (42%) despite resolution of symptoms. Although preliminary, these data suggest ABLC has significant activity in patients with AIDS-associated cryptococcal meningitis. Because this formulation has less hematologic and renal toxicity than does AmB, further evaluation of ABLC is warranted.
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No method currently exists to predict which patients with acute AIDS-associated cryptococcal meningitis can be effectively treated with fluconazole. The objective of this study was to determine the relationship of cryptococcal susceptibility to fluconazole, along with clinical variables, to the risk of treatment failure for patients with acute AIDS-associated cryptococcal meningitis. Results of in vitro fluconazole susceptibility testing of cryptococcal isolates and data from two clinical trials were analyzed. ⋯ Seventy-six patients receiving fluconazole +/- flucytosine were included; therapy failed for 19. Patients whose therapy failed were more likely to have a positive blood and urine culture and a higher titer in serum and cerebrospinal fluid of cryptococcal antigen, and the MIC of fluconazole against their isolates (as determined by the microtiter method) was more likely to be higher; they were less likely to have received flucytosine. Logistic regression modeling revealed that a negative blood culture, a low MIC of fluconazole (per the microtiter method), and treatment with flucytosine were factors independently associated with successful treatment.
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Multicenter Study
Epidemiology and cost of infection with human parainfluenza virus types 1 and 2 in young children.
To determine the morbidity, costs, and epidemiological features of lower respiratory tract infections (LRIs) due to human parainfluenza virus types 1 and 2 (HPIV-1 and HPIV-2), we evaluated 1,213 children < 6 years of age who were seen for LRIs in the emergency room of the Children's Hospital of Wisconsin and/or were admitted to the hospital for LRIs during the fall quarter of 1991. The age, sex, race, and respiratory syndrome were recorded for each child; 158 patients (13%) had respiratory samples cultured for viruses and were followed clinically for the duration of their illness. Caucasian children had croup diagnosed more often than did African-American children (relative risk [RR] = 3.12; 95% confidence interval [CI], 2.43-4.00; P < .001), while African-American children more often had pneumonia (RR = 1.85; 95% CI, 1.36-2.5; P < .001). ⋯ Together these two viruses were recovered from 49% of children presenting with croup, 10% of those presenting with bronchiolitis, and 12% of those presenting with pneumonia. Gender- and race-associated differences were documented in the group of children infected with HPIV-2: specifically, this group included more girls than boys (RR = 1.99; 95% CI, 1.02-3.88; P < .04) and more Caucasian than African-American children (RR = 2.64; 95% CI, 1.05-6.63; P = .027). These data extrapolate nationally to approximately 250,000 emergency-room visits and approximately 70,000 hospitalizations due to HPIV-1 and HPIV-2, with a cost of $50 million for the former and $140 million for the latter.