TABLE 2.

Details of therapeutic studies^a

Study no.	No. of centers, location	Underlying diagnosis	Indication	Fluconazole dosage (mg/kg/day), route of administration	Comparator(s)
178	32, USA	Immunocompromise	Oropharyngeal candidiasis	2 or 3, p.o.b	Nystatin, 1,600,000 U, p.o.
368	1, France	HIV infection	Prophylaxis	1, p.o.	Ketoconazole, 5 mg/kg, p.o.
369	1, UK	Prematurity	Prophylaxis	1, p.o. or i.v.	Nystatin, 400,000 U, p.o.
370	7, Europe	HIV infection	Oropharyngeal candidiasis	2 or 3, p.o.	Ketoconazole, 3.5 or 7 mg/kg, p.o.
372	12, Europe	None	Systemic fungal infection	6–12, p.o. or i.v.	None
373	23, Europe and Canada	Hematological or oncological malignancy	Prophylaxis	3, p.o.	Nystatin, 50,000 U/kg, p.o. or amphotericin B, 25 mg/kg, p.o.

Mean duration of therapy [days (range)]		No. of patients		Mean age (range)		Reference
Fluconazole-treated group	Comparison group	Fluconazole-treated group	Comparison group	Fluconazole-treated group	Comparison group
13 (1–29)	12 (2–27)	94	88	5.1 yr (NA)	5.3 yr (NA)	Flynn et al. (9)
90 (53–129)	68 (8–134)	6	7	5.8 yr (1–12 yr)	3.7 yr (0–7 yr)	Pfizer, Inc. (21a)
13 (1–18) (p.o.) and 16 (14–19) (i.v.)	18 (15–35)	7 (p.o.) and  6 (i.v.)	7	17.9 d (5–47 d) (p.o.)  21.2 d (9–38 d) (i.v.)	9.9 d (6–20 d)	Pfizer, Inc. (21a)
14 (6–33)	16 (5–49)	24	22	4.6 yr (0–14 yr)	3.8 yr (0–12 yr)	Hernández-Sampelayo et al. (14)
20 (5–162)		51		5.3 yr (0.1–17 yr)		Presterl et al. (23)
28 (1–89)	29 (1–112)	245	257	6.8 yr (0–17 yr)	6.8 yr (0–17 yr)	Ninane et al. (20)

^aAbbreviations: USA, United States; UK, United Kingdom; p.o., orally; i.v., intravenously; NA, not available; d, days. 

^bLoading dose of 4 or 6 mg/kg on first day of treatment.