John E. Bennett Forum on Deep Mycoses Study Design 2004: Candidiasis and salvage therapy for aspergillosis.
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Antifungal Agents↗
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Treatment of blastomycosis with higher doses of fluconazole. The National Institute of Allergy and Infectious Diseases Mycoses Study Group.
Recent clinical data suggest that fluconazole at daily doses of 200 to 400 mg for at least 6 months is moderately effective therapy for non-life-threatening blastomycosis. To examine the usefulness of higher doses of fluconazole therapy for this disorder, we conducted a multicenter, randomized, open-label study to determine the efficacy and safety of two different daily doses of fluconazole (400 and 800 mg) in the treatment of non-life-threatening blastomycosis. Of 39 patients evaluable for efficacy analysis, 34 (87%) were successfully treated, including 89% and 85% of patients who received 400 and 800 mg, respectively. Five (83%) of six patients for whom prior antifungal therapy had failed were successfully treated. The mean duration of therapy was 8.9 months for successfully treated patients. Nineteen patients (48%) reported adverse events, although most were minor. We conclude that fluconazole at daily doses of 400 to 800 mg for at least 6 months is effective therapy for non-life-threatening blastomycosis.
Adolescent↗
A comparison of itraconazole versus fluconazole as maintenance therapy for AIDS-associated cryptococcal meningitis. National Institute of Allergy and Infectious Diseases Mycoses Study Group.
This study was designed to compare the effectiveness of fluconazole vs. itraconazole as maintenance therapy for AIDS-associated cryptococcal meningitis. HIV-infected patients who had been successfully treated (achieved negative culture of CSF) for a first episode of cryptococcal meningitis were randomized to receive fluconazole or itraconazole, both at 200 mg/d, for 12 months. The study was stopped prematurely on the recommendation of an independent Data Safety and Monitoring Board. At the time, 13 (23%) of 57 itraconazole recipients had experienced culture-positive relapse, compared with 2 relapses (4%) noted among 51 fluconazole recipients (P = .006). The factor best associated with relapse was the patient having not received flucytosine during the initial 2 weeks of primary treatment for cryptococcal disease (relative risk = 5.88; 95% confidence interval, 1.27-27.14; P = .04). Fluconazole remains the treatment of choice for maintenance therapy for AIDS-associated cryptococcal disease. Flucytosine may contribute to the prevention of relapse if used during the first 2 weeks of primary therapy.
AIDS-Related Opportunistic Infections↗
National epidemiology of mycoses survey (NEMIS): variations in rates of bloodstream infections due to Candida species in seven surgical intensive care units and six neonatal intensive care units.
Candida species are the fourth most frequent cause of nosocomial bloodstream infections, and 25%-50% occur in critical care units. During an 18-month prospective study period, all patients admitted for > or = 72 hours to the surgical (SICUs) or neonatal intensive care units (NICUs) at each of the participant institutions were followed daily. Among 4,276 patients admitted to the seven SICUs in six centers, there were 42 nosocomial bloodstream infections due to Candida species (9.8/1,000 admissions; 0.99/1,000 patient-days). Of 2,847 babies admitted to the six NICUs, 35 acquired a nosocomial bloodstream infection due to Candida species (12.3/1,000 admissions; 0.64/1,000 patient-days). The following were the most commonly isolated Candida species causing bloodstream infections in the SICU: Candida albicans, 48%; Candida glabrata, 24%; Candida tropicalis, 19%; Candida parapsilosis, 7%; Candida species not otherwise specified, 2%. In the NICU the distribution was as follows: C. albicans, 63%; C. glabrata, 6%; C. parapsilosis, 29%; other, 3%. Of the patients, 30%-50% developed incidental stool colonization, 23% of SICU patients developed incidental urine colonization, and one-third of SICU health care workers' hands were positive for Candida species.
Candidiasis↗
An improved technic for the demonstration of superficial mycoses.
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Dermatomycoses↗
Chronic mucocutaneous candidosis and other superficial and systemic mycoses successfully treated with ketoconazole.
Four patients with chronic mucocutaneous candidosis from early infancy were treated successfully with ketoconazole given orally. All thrush lesions were clinically and mycologically cured within a few days of treatment with 100-400 micrograms of ketoconazole daily; skin lesions were cured within a few weeks, and nails were cured after about three months of treatment. Delayed cutaneous hypersensitivity to candidin was acquired by the third month. Cellular and humoral immunologic responses were related to the suppression of Candida albicans antigen by ketoconazole. A fifth patient with chronic lingual granuloma due to C. albicans improved considerably. Favorable results also were seen in individual patients with oral and disseminated histoplasmosis due to Histoplasma capsulatum; laryngeal, pulmonary, and hepatic disease with continuous fever also due to H. capsulatum; pulmonary histoplasmosis due to Histoplasma duboisii; cutaneous sporotrichosis; and cutaneous blastomycosis due to Blastomyces dermatitidis and in three patients with favus due to Trichophyton schoenleinii; six of seven patients with tinea capitis due to Trichophyton violaceum (after one month of treatment); and four patients with infections due to Petriellidium boydii, Phialophora pedrosoi, or Beauveria species. All patients responded rapidly to 400 mg of ketoconazole per day given orally. Only the patient with hepatic histoplasmosis required 800 mg per day. Measurements of ketoconazole in the serum during treatment were useful in the evaluation of therapy.
Adolescent↗
Treatment of blastomycosis with fluconazole: a pilot study. The National Institute of Allergy and Infectious Diseases Mycoses Study Group.
There are few clinical data concerning the use of fluconazole, a triazole antifungal agent with in vitro activity against Blastomyces dermatitidis, in the treatment of human blastomycosis. We conducted a multicenter, randomized, open-label pilot trial comparing two daily doses of fluconazole (200 mg and 400 mg) in the treatment of non-life-threatening, non-CNS blastomycosis. Twenty-four patients were enrolled in the study, and 23 patients were evaluable for efficacy analysis. Overall, treatment of 15 (65%) of 23 patients was successful, including eight (62%) of 13 who received 200 mg daily and seven (70%) of 10 who received 400 mg daily. The mean duration of therapy for successfully treated patients was 6.7 months. Of the six patients whose prior antifungal therapy had failed, all six eventually responded to fluconazole treatment. We conclude that fluconazole (200 mg to 400 mg daily) given for at least 6 months is moderately effective treatment for blastomycosis.
Adolescent↗
Intravascular catheter exchange and duration of candidemia. NIAID Mycoses Study Group and the Candidemia Study Group.
During a comparative trial of amphotericin B vs. fluconazole for treatment of candidemia in nonneutropenic patients, data on the management of intravascular catheters were collected. Complete records were available for 91% of the 206 study patients. For the subset of patients with a catheter in place at the time of their first positive blood culture, removal and replacement of all intravascular catheters without exchange over a guidewire from a preexisting line on or before the first day the study drug was administered were associated with a reduction in the subsequent mean duration (+/- SE) of candidemia, from 5.6 +/ -0.8 days to 2.6 +/- 0.5 days (P < .001).
Amphotericin B↗
Fluconazole therapy for histoplasmosis. The National Institute of Allergy and Infectious Diseases Mycoses Study Group.
We assessed the efficacy of oral fluconazole (200-800 mg daily) in the treatment of non-life-threatening acute pulmonary histoplasmosis, chronic pulmonary histoplasmosis, or disseminated histoplasmosis in patients without human immunodeficiency virus infection. Of 27 evaluable patients, two had progressive acute pulmonary histoplasmosis, 11 had chronic pulmonary histoplasmosis, and 14 had disseminated histoplasmosis. Median durations of treatment in each of the three groups were 6 months, 7 months, and 11 months, respectively. Nineteen patients were treated with 400 mg of fluconazole daily (two of these patients received 800 mg daily for a portion of their treatment courses), seven were treated with 200 mg daily, and one was treated with 800 mg daily. Treatment was successful in 17 (63%) of 27 cases. Both of the patients with acute pulmonary infection responded to therapy, as did five (46%) of 11 patients with chronic pulmonary infection and 10 (71%) of 14 patients with disseminated infection. No substantial toxicity was observed. We conclude that fluconazole therapy for histoplasmosis is only moderately effective and should be reserved for patients who cannot take itraconazole.
Female↗
Mycoses caused by Candida lusitaniae.
Candida lusitaniae, a fungus with a low incidence of infection in immunocompetent people, is emerging as an opportunistic pathogen in immunocompromised hosts. This yeast is generally resistant to amphotericin B and may present therapeutic difficulties. C. lusitaniae may be misidentified as one of several other fungal species, including Candida tropicalis, Candida parapsilosis, and even Saccharomyces cerevisiae. As judged by in vitro antifungal susceptibility testing, minimal inhibitory concentrations of antifungal agents other than amphotericin B are achievable, but fungicidal levels are not. When encountered in blood or other body sites, C. lusitaniae should be carefully considered as a potential pathogen.
Aged↗
Randomized comparative trial of three regimens of itraconazole for treatment of vaginal mycoses.
A randomized comparative study of three treatment regimens with itraconazole was carried out in 60 nonpregnant women with acute vaginal candidosis. Vaginitis was demonstrated by both a positive culture and positive findings on microscopic examination of a vaginal smear as well as by the presence of clinical symptoms. Sixty patients seen over a three-month period were randomly allocated to receive one dose of 200 mg daily for two consecutive days (regimen A), 200 mg twice a day for one day (regimen B), or 200 mg once a day for three consecutive days (regimen C). Each group comprised 20 patients. In group A, 65% were clinically and microbiologically cured, 5% were clinically but not microbiologically cured, and 30% relapsed. In group B, 55% were clinically and microbiologically cured, 10% were clinically but not microbiologically cured, 15% did not respond to treatment, and 20% relapsed. In group C, 75% were clinically and microbiologically cured, 10% did not respond, and 15% relapsed.
Adult↗
Immology of the mycoses. II. Characterization of the immunoglobulin and antibody responses in histoplasmosis.
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Acute Disease↗
Fluconazole failure in the treatment of invasive mycoses.
Fluconazole is a recently licensed antifungal agent that has gained widespread use in the medical community. Despite a lack of controlled trials in invasive fungal infections, this agent is often prescribed because of ease of administration and concern over amphotericin B toxicity. Three cases of systemic fungal infections in which fluconazole use resulted in unambiguous microbiologic and clinical failure are reported.
Amphotericin B↗
Tumor necrosis factor-alpha and interleukin-1 beta in cerebrospinal fluid of patients with coccidioidal meningitis during therapy with fluconazole. National Institute of Allergy and Infectious Diseases Mycoses Study Group.
The levels of tumor necrosis factor-alpha (TNF-alpha) and interleukin (IL)-1 beta in the cerebrospinal fluid (CSF) of 66 patients with coccidioidal meningitis during therapy with fluconazole were measured by ELISA. The median concentration of TNF-alpha was 15.2 pg/mL for 322 samples; for IL-1 beta, it was 4.7 pg/mL for 316 samples. There were no significant changes in the level of either cytokine over 24 months of follow-up nor was there an association between the initial CSF concentrations of TNF-alpha and IL-1 beta and subsequent fluconazole treatment failure. Over time, concentrations of IL-1 beta were significantly associated with both clinical symptoms and white blood cell counts in CSF. These results indicate that CSF levels of TNF-alpha and IL-1 beta are relatively low compared with those associated with acute bacterial meningitis.
Coccidioidomycosis↗
Cerebrospinal fluid antibodies detected by ELISA against a 33-kDa antigen from spherules of Coccidioides immitis in patients with coccidioidal meningitis. The National Institute of Allergy and Infectious Diseases Mycoses Study Group.
Antibodies against a 33-kDa antigen from Coccidioides immitis were detected by ELISA in patients' cerebrospinal fluid (CSF). Anti-33-kDa antibodies were detected at dilutions > 1:80 in only 1 (1.4%) of 73 patients without coccidioidal meningitis but in 74 (71.8%) of 103 with meningitis. Anti-33-kDa antibodies were detected in 53 (91.4%) of 58 patients whose anti-coccidioidal complement-fixing (CF) antibodies were detectable and in 21 (46.7%) of 45 patients whose CSF was negative by CF test (positive predictive value, 99%; negative predictive value, 71%; sensitivity, 72%; specificity, 99%). Anti-33-kDa antibodies, among which IgG1 was the dominant subclass, increased when infections worsened and decreased when patients' conditions improved. Antibody concentration appeared to be independent of most baseline findings, although only 1 of 5 patients coinfected with human immunodeficiency virus had initially detectable antibodies. Measurement of anti-33-kDa antibodies is a sensitive indicator of coccidioidal meningitis and of its clinical course.
Antibodies, Fungal↗
Invasive mycoses: management and unmet medical needs.
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Aspergillosis↗
Amorolfine spray in the treatment of foot mycoses (a dose-finding study).
A total of 382 patients with foot mycosis were entered into a dose-finding study. Patients were randomly treated with amorolfine spray 0.5% or 2% (double-blind) or cream 0.5% (open; used as a reference agent). The spray or cream was applied once daily for 4 weeks on average. At screening, in 348 patients evaluable for efficacy, a total of 381 fungi were isolated: Trichopyton rubrum (196), T. mentagrophytes (73), other dermatophytes (17), Candida albicans (65), other yeasts (23), and moulds (7). In 33 patients the fungal infection was mixed. Two weeks after the end of treatment, the culture was negative in 94.1% and 97.4% of patients treated with 0.5% or 2% amorolfine spray, respectively. The difference was not statistically significant. In the 0.5% cream group the culture was negative in 86.6% of patients. Nine out of 380 patients evaluable for safety had local adverse events: four (3.2%) in each of the spray groups, and one (0.8%) in the cream group. The most common local adverse events in the patients treated with spray were a burning sensation and dryness of the skin. In conclusion, both spray concentrations were highly efficacious and well tolerated. Further studies should show if more widely spaced treatment with amorolfine spray is as effective as daily administration.
Adult↗
Itraconazole in the treatment of superficial mycoses--a double-blind study vs. placebo.
Ninety-four patients with dermatophytosis and 16 patients with pityriasis versicolor were assigned under double-blind conditions to oral itraconazole (100 mg once daily) or placebo. The medication consisted of two capsules, each containing 50 mg of active substance, or placebo and was given for 15 or 30 days in patients with dermatophytosis and for 15 days in patients with pityriasis versicolor. Patients with pityriasis versicolor who had not responded at the end of the double-blind period were treated on an open basis with itraconazole (100 mg once daily) for 15 days. In the treatment of dermatophyte infections for 30 days, both clinical response and mycological cure were significantly superior in the itraconazole group compared with placebo. Oral administration of itraconazole (100 mg once daily) was also highly efficacious in the treatment of pityriasis versicolor. None of the placebo patients was clinically or mycologically cured at the end of the double-blind phase compared to seven out of eight itraconazole patients. All placebo patients who entered the open phase responded to itraconazole treatment. Three itraconazole-treated patients and nine placebo-treated patients reported side-effects.
Adolescent↗