This study aims to recruit 786 subjects who are eligible for inclusion in the modified intent-to-treat analysis. The study compares the efficacy, the safety and tolerance, the survival, the incidence of breakthrough deeply invasive fungal infections and the time to defervescence of voriconazole versus Ambisome, in the empirical treatment of fungal infections in immunocompromised patients with persistent fever and neutropenia. The majority of the subjects enrolled in this study will be treated with empirical antifungal medication until recovery from neutropenia (typically two weeks), with a follow-up clinical assessment seven days after the last dose of empirical therapy. Subjects who are diagnosed with a deeply invasive fungal infection can be treated until resolution of the infection up to a maximum of twelve weeks. Patients meeting all inclusion/exclusion criteria will be randomly assigned to receive treatment with either IV voriconazole for at least 3 days, followed by oral voriconazole, until recovery from neutropenia or IV AmBisome until recovery from neutropenia. Patients will be hospitalized at the beginning of study treatment and will remain until recovery from neutropenia. Assessments will be performed weekly until recovery from neutropenia. Patients without baseline or breakthrough deeply invasive fungal infections will have additional assessments performed every four weeks while on study medication, at the end of treatment, and at four weeks after the end of treatment. Evaluations will include hospitalizations, concomitant illnesses, ophthalmological safety assessment, adverse events, concurrent medications, vital signs, and laboratory analysis.

Project Start
1999-12-01
Project End
2000-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
11
Fiscal Year
2000
Total Cost
$11,180
Indirect Cost
Name
Tulane University
Department
Type
DUNS #
City
New Orleans
State
LA
Country
United States
Zip Code
70118
Allegrezza, Michael J; Rutkowski, Melanie R; Stephen, Tom L et al. (2016) Trametinib Drives T-cell-Dependent Control of KRAS-Mutated Tumors by Inhibiting Pathological Myelopoiesis. Cancer Res 76:6253-6265
Drerup, Justin M; Liu, Yang; Padron, Alvaro S et al. (2015) Immunotherapy for ovarian cancer. Curr Treat Options Oncol 16:317
Chyun, Deborah A; Wackers, Frans J Th; Inzucchi, Silvio E et al. (2015) Autonomic dysfunction independently predicts poor cardiovascular outcomes in asymptomatic individuals with type 2 diabetes in the DIAD study. SAGE Open Med 3:2050312114568476
Rahman, Mahboob; Xie, Dawei; Feldman, Harold I et al. (2014) Association between chronic kidney disease progression and cardiovascular disease: results from the CRIC Study. Am J Nephrol 40:399-407
Kempen, John H; Sugar, Elizabeth A; Varma, Rohit et al. (2014) Risk of cataract among subjects with acquired immune deficiency syndrome free of ocular opportunistic infections. Ophthalmology 121:2317-24
Ricardo, Ana C; Yang, Wei; Lora, Claudia M et al. (2014) Limited health literacy is associated with low glomerular filtration in the Chronic Renal Insufficiency Cohort (CRIC) study. Clin Nephrol 81:30-7
Kozak, Igor; Vaidya, Vijay; Van Natta, Mark L et al. (2014) The prevalence and incidence of epiretinal membranes in eyes with inactive extramacular CMV retinitis. Invest Ophthalmol Vis Sci 55:4304-12
Wing, Maria R; Devaney, Joseph M; Joffe, Marshall M et al. (2014) DNA methylation profile associated with rapid decline in kidney function: findings from the CRIC study. Nephrol Dial Transplant 29:864-72
Mariani, Laura H; White, Matthew T; Shults, Justine et al. (2014) Increasing use of vitamin D supplementation in the chronic renal insufficiency cohort study. J Ren Nutr 24:186-93
Wing, Maria R; Yang, Wei; Teal, Valerie et al. (2014) Race modifies the association between adiposity and inflammation in patients with chronic kidney disease: findings from the chronic renal insufficiency cohort study. Obesity (Silver Spring) 22:1359-66

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