Treatment options for patients with oropharyngeal or esophageal candidiasis are limited usually to parenteral administration of amphotericin B. Some patients may respond to administration of other azoles (particularly itraconazole) or higher doses of amphotericin B. The objectives of this multicenter protocol are to compare the safety and efficacy of various doses of MK-0991 (an antifungal agent structurally similar to the echinocandin class) to amphotericin B for the treatment of these infections. Male or nonpregnant, nonlactating female patients ages 18-65 years with a diagnosis of mycologically-proven oropharyngeal or esophageal candidiasis will be recruited for this study. Patients with significant laboratory abnormalities (anemia, neutropenia, thrombocytopenia, renal insufficiency, hypoprothrombinemia, elevated liver function tests), allergy or significant intolerance to echinocandins or amphotericin B, amphotericin B failures, newly diagnosed opportunistic infections, esophagitis of other etiologies, unable to undergo esophagoscopy (if esophageal involvement evident), acute or chronic hepatitis, or selected concomitant nephrotoxins, rifampin, rifabutin, or ritonavir will be excluded. Consenting patients will receive a complete physical and medical history. A chest x-ray, electrocardiogram, and procedures to obtain samples of the infection (oropharyngeal swab or esophagoscopy) will be performed as part of routine care. Blood and urine collections will be taken. The medication will be selected at random, with an even chance of receiving one of four treatments.

Project Start
1997-12-01
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
37
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Duke University
Department
Type
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705
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
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
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
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
Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417
Ahmed, Zuhayer; Prasad, Indrajit; Rahman, Hafizur et al. (2016) A Male with Extreme Subcutaneous Insulin Resistance: A Case Report. Rom J Diabetes Nutr Metab Dis 23:209-213
Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17
Barroso, Julie; Leserman, Jane; Harmon, James L et al. (2015) Fatigue in HIV-Infected People: A Three-Year Observational Study. J Pain Symptom Manage 50:69-79
Stafford-Smith, Mark; Li, Yi-Ju; Mathew, Joseph P et al. (2015) Genome-wide association study of acute kidney injury after coronary bypass graft surgery identifies susceptibility loci. Kidney Int 88:823-32

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