Abstract

The primary purpose of this study is to assess the safety of IV itraconazole compared to the standard of care (Amphotericin B). The study will also assess the clinical, microbiological, and overall response to therapy at the end of IV induction therapy (7-14 days) and after PO consolidation therapy at 2, 12, and 24 weeks. Patients will be randomized to either an initial treatment with IV itraconazole twice a day for 2 days (loading dose) and then once a day for 5 additional days or amphotericin-B IV for 7 days. Extended treatment would be allowed if the clinical condition required it. IV treatment will be followed by consolidation therapy with itraconazole capsules once daily for twice a day for up to one year. During induction therapy (7-14 days) IV itraconazole is infused over a one-hour period of time. IV Amphotericin-B is infused over a 1-6 hour period of time depending on the side effects to therapy. During consolidation therapy oral itraconazole is given either once a day or twice a day for up to 1 year.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000032-39
Application #
6112840
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
39
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

Name
University of Alabama Birmingham
Department
Type
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294

  Publications

Yu, Alan S L; Shen, Chengli; Landsittel, Douglas P et al. (2018) Baseline total kidney volume and the rate of kidney growth are associated with chronic kidney disease progression in Autosomal Dominant Polycystic Kidney Disease. Kidney Int 93:691-699
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
McKenzie, Katelyn A; El Ters, Mirelle; Torres, Vicente E et al. (2018) Relationship between caffeine intake and autosomal dominant polycystic kidney disease progression: a retrospective analysis using the CRISP cohort. BMC Nephrol 19:378
Denson, Lee A; McDonald, Scott A; Das, Abhik et al. (2017) Early Elevation in Interleukin-6 is Associated with Reduced Growth in Extremely Low Birth Weight Infants. Am J Perinatol 34:240-247
Kline, Timothy L; Korfiatis, Panagiotis; Edwards, Marie E et al. (2017) Image texture features predict renal function decline in patients with autosomal dominant polycystic kidney disease. Kidney Int 92:1206-1216
James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Morrison, Shannon A; Goss, Amy M; Azziz, Ricardo et al. (2017) Peri-muscular adipose tissue may play a unique role in determining insulin sensitivity/resistance in women with polycystic ovary syndrome. Hum Reprod 32:185-192
Shen, Chengli; Landsittel, Douglas; Irazabal, María V et al. (2017) Performance of the CKD-EPI Equation to Estimate GFR in a Longitudinal Study of Autosomal Dominant Polycystic Kidney Disease. Am J Kidney Dis 69:482-484

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