Table 1.

Baseline characteristics (FAS population)

CharacteristicCaspofungin (2 mg/kg), n=31dAMB (1 mg/kg), n=16Total, N=47
Age (days), median (minimum–maximum)22.0 (11–88)25.0 (7–74)22 (7–88)
Sex, n (%)
  male18 (58.1)7 (43.8)25 (53.2)
  female13 (41.9)9 (56.3)22 (46.8)
Race, n (%)
  white12 (38.7)7 (43.8)19 (40.4)
  black or African American11 (35.5)6 (37.5)17 (36.2)
  multiracial5 (16.1)2 (12.5)7 (14.9)
  American Indian/Alaskan Native3 (9.7)1 (6.3)4 (8.5)
Ethnicity, n (%)
  Hispanic or Latino11 (35.5)7 (43.8)18 (38.3)
  not Hispanic or Latino19 (61.3)8 (50.0)27 (57.4)
  unknown/not reported1 (3.2)1 (6.3)2 (4.3)
Baseline weight (g)
  median (range)1910 (810–4410)1684 (425–6540)1860 (425–6540)
  <1000, n (%)4 (12.9)3 (18.8)7 (14.9)
  1000 to 1500, n (%)9 (29.0)4 (25.0)13 (27.7)
  >1500, n (%)18 (58.1)9 (56.3)27 (57.4)
Gestational age (weeks), median (minimum–maximum)32.0 (26.0–41.0)30.0 (26.7–40.0)30.4 (26.0–41.0)
Birth weight (g)
  median (minimum–maximum)1335.0 (850–3985)1462.5 (510–4175)1445.0 (510–4175)
  <1000, n (%)7 (22.6)3 (18.8)10 (21.3)
  1000 to 1500, n (%)11 (35.5)6 (37.5)17 (36.2)
  >1500, n (%)13 (41.9)7 (43.8)20 (42.6)
Baseline fungal isolates, n (%)
C. albicans27 (87.1)12 (75.0)39 (83.0)
Candida glabrata01 (6.3)1 (2.1)
Candida intermedia1 (3.2)01 (2.1)
Candida parapsilosis1 (3.2)1 (6.3)2 (4.3)
Candida tropicalis1 (3.2)01 (2.1)
C. albicans/C. glabrata1 (3.2)01 (2.1)
Pichia kudriavzevii01 (6.3)1 (2.1)
  unspecified01 (6.3)1 (2.1)
Associated fungal diagnosis, n/N (%)
  candidaemia24/31 (77.4)8/16 (50.0)32/47 (68.1)
  urinary tract infection3/31 (9.7)2/16 (12.5)5/47 (10.6)
  endocarditis1/31 (3.2)1/16 (6.3)2/47 (4.3)
  lung infection1/31 (3.2)1/16 (6.3)2/47 (4.3)
  meningoencephalitisa1/31 (3.2)1/16 (6.3)2/47 (4.3)
  endophthalmitis01/16 (6.3)1/47 (2.1)
  peritonitis01/16 (6.3)1/47 (2.1)
CharacteristicCaspofungin (2 mg/kg), n=31dAMB (1 mg/kg), n=16Total, N=47
Age (days), median (minimum–maximum)22.0 (11–88)25.0 (7–74)22 (7–88)
Sex, n (%)
  male18 (58.1)7 (43.8)25 (53.2)
  female13 (41.9)9 (56.3)22 (46.8)
Race, n (%)
  white12 (38.7)7 (43.8)19 (40.4)
  black or African American11 (35.5)6 (37.5)17 (36.2)
  multiracial5 (16.1)2 (12.5)7 (14.9)
  American Indian/Alaskan Native3 (9.7)1 (6.3)4 (8.5)
Ethnicity, n (%)
  Hispanic or Latino11 (35.5)7 (43.8)18 (38.3)
  not Hispanic or Latino19 (61.3)8 (50.0)27 (57.4)
  unknown/not reported1 (3.2)1 (6.3)2 (4.3)
Baseline weight (g)
  median (range)1910 (810–4410)1684 (425–6540)1860 (425–6540)
  <1000, n (%)4 (12.9)3 (18.8)7 (14.9)
  1000 to 1500, n (%)9 (29.0)4 (25.0)13 (27.7)
  >1500, n (%)18 (58.1)9 (56.3)27 (57.4)
Gestational age (weeks), median (minimum–maximum)32.0 (26.0–41.0)30.0 (26.7–40.0)30.4 (26.0–41.0)
Birth weight (g)
  median (minimum–maximum)1335.0 (850–3985)1462.5 (510–4175)1445.0 (510–4175)
  <1000, n (%)7 (22.6)3 (18.8)10 (21.3)
  1000 to 1500, n (%)11 (35.5)6 (37.5)17 (36.2)
  >1500, n (%)13 (41.9)7 (43.8)20 (42.6)
Baseline fungal isolates, n (%)
C. albicans27 (87.1)12 (75.0)39 (83.0)
Candida glabrata01 (6.3)1 (2.1)
Candida intermedia1 (3.2)01 (2.1)
Candida parapsilosis1 (3.2)1 (6.3)2 (4.3)
Candida tropicalis1 (3.2)01 (2.1)
C. albicans/C. glabrata1 (3.2)01 (2.1)
Pichia kudriavzevii01 (6.3)1 (2.1)
  unspecified01 (6.3)1 (2.1)
Associated fungal diagnosis, n/N (%)
  candidaemia24/31 (77.4)8/16 (50.0)32/47 (68.1)
  urinary tract infection3/31 (9.7)2/16 (12.5)5/47 (10.6)
  endocarditis1/31 (3.2)1/16 (6.3)2/47 (4.3)
  lung infection1/31 (3.2)1/16 (6.3)2/47 (4.3)
  meningoencephalitisa1/31 (3.2)1/16 (6.3)2/47 (4.3)
  endophthalmitis01/16 (6.3)1/47 (2.1)
  peritonitis01/16 (6.3)1/47 (2.1)
a

Meningoencephalitis was confirmed by lumbar puncture.

Table 1.

Baseline characteristics (FAS population)

CharacteristicCaspofungin (2 mg/kg), n=31dAMB (1 mg/kg), n=16Total, N=47
Age (days), median (minimum–maximum)22.0 (11–88)25.0 (7–74)22 (7–88)
Sex, n (%)
  male18 (58.1)7 (43.8)25 (53.2)
  female13 (41.9)9 (56.3)22 (46.8)
Race, n (%)
  white12 (38.7)7 (43.8)19 (40.4)
  black or African American11 (35.5)6 (37.5)17 (36.2)
  multiracial5 (16.1)2 (12.5)7 (14.9)
  American Indian/Alaskan Native3 (9.7)1 (6.3)4 (8.5)
Ethnicity, n (%)
  Hispanic or Latino11 (35.5)7 (43.8)18 (38.3)
  not Hispanic or Latino19 (61.3)8 (50.0)27 (57.4)
  unknown/not reported1 (3.2)1 (6.3)2 (4.3)
Baseline weight (g)
  median (range)1910 (810–4410)1684 (425–6540)1860 (425–6540)
  <1000, n (%)4 (12.9)3 (18.8)7 (14.9)
  1000 to 1500, n (%)9 (29.0)4 (25.0)13 (27.7)
  >1500, n (%)18 (58.1)9 (56.3)27 (57.4)
Gestational age (weeks), median (minimum–maximum)32.0 (26.0–41.0)30.0 (26.7–40.0)30.4 (26.0–41.0)
Birth weight (g)
  median (minimum–maximum)1335.0 (850–3985)1462.5 (510–4175)1445.0 (510–4175)
  <1000, n (%)7 (22.6)3 (18.8)10 (21.3)
  1000 to 1500, n (%)11 (35.5)6 (37.5)17 (36.2)
  >1500, n (%)13 (41.9)7 (43.8)20 (42.6)
Baseline fungal isolates, n (%)
C. albicans27 (87.1)12 (75.0)39 (83.0)
Candida glabrata01 (6.3)1 (2.1)
Candida intermedia1 (3.2)01 (2.1)
Candida parapsilosis1 (3.2)1 (6.3)2 (4.3)
Candida tropicalis1 (3.2)01 (2.1)
C. albicans/C. glabrata1 (3.2)01 (2.1)
Pichia kudriavzevii01 (6.3)1 (2.1)
  unspecified01 (6.3)1 (2.1)
Associated fungal diagnosis, n/N (%)
  candidaemia24/31 (77.4)8/16 (50.0)32/47 (68.1)
  urinary tract infection3/31 (9.7)2/16 (12.5)5/47 (10.6)
  endocarditis1/31 (3.2)1/16 (6.3)2/47 (4.3)
  lung infection1/31 (3.2)1/16 (6.3)2/47 (4.3)
  meningoencephalitisa1/31 (3.2)1/16 (6.3)2/47 (4.3)
  endophthalmitis01/16 (6.3)1/47 (2.1)
  peritonitis01/16 (6.3)1/47 (2.1)
CharacteristicCaspofungin (2 mg/kg), n=31dAMB (1 mg/kg), n=16Total, N=47
Age (days), median (minimum–maximum)22.0 (11–88)25.0 (7–74)22 (7–88)
Sex, n (%)
  male18 (58.1)7 (43.8)25 (53.2)
  female13 (41.9)9 (56.3)22 (46.8)
Race, n (%)
  white12 (38.7)7 (43.8)19 (40.4)
  black or African American11 (35.5)6 (37.5)17 (36.2)
  multiracial5 (16.1)2 (12.5)7 (14.9)
  American Indian/Alaskan Native3 (9.7)1 (6.3)4 (8.5)
Ethnicity, n (%)
  Hispanic or Latino11 (35.5)7 (43.8)18 (38.3)
  not Hispanic or Latino19 (61.3)8 (50.0)27 (57.4)
  unknown/not reported1 (3.2)1 (6.3)2 (4.3)
Baseline weight (g)
  median (range)1910 (810–4410)1684 (425–6540)1860 (425–6540)
  <1000, n (%)4 (12.9)3 (18.8)7 (14.9)
  1000 to 1500, n (%)9 (29.0)4 (25.0)13 (27.7)
  >1500, n (%)18 (58.1)9 (56.3)27 (57.4)
Gestational age (weeks), median (minimum–maximum)32.0 (26.0–41.0)30.0 (26.7–40.0)30.4 (26.0–41.0)
Birth weight (g)
  median (minimum–maximum)1335.0 (850–3985)1462.5 (510–4175)1445.0 (510–4175)
  <1000, n (%)7 (22.6)3 (18.8)10 (21.3)
  1000 to 1500, n (%)11 (35.5)6 (37.5)17 (36.2)
  >1500, n (%)13 (41.9)7 (43.8)20 (42.6)
Baseline fungal isolates, n (%)
C. albicans27 (87.1)12 (75.0)39 (83.0)
Candida glabrata01 (6.3)1 (2.1)
Candida intermedia1 (3.2)01 (2.1)
Candida parapsilosis1 (3.2)1 (6.3)2 (4.3)
Candida tropicalis1 (3.2)01 (2.1)
C. albicans/C. glabrata1 (3.2)01 (2.1)
Pichia kudriavzevii01 (6.3)1 (2.1)
  unspecified01 (6.3)1 (2.1)
Associated fungal diagnosis, n/N (%)
  candidaemia24/31 (77.4)8/16 (50.0)32/47 (68.1)
  urinary tract infection3/31 (9.7)2/16 (12.5)5/47 (10.6)
  endocarditis1/31 (3.2)1/16 (6.3)2/47 (4.3)
  lung infection1/31 (3.2)1/16 (6.3)2/47 (4.3)
  meningoencephalitisa1/31 (3.2)1/16 (6.3)2/47 (4.3)
  endophthalmitis01/16 (6.3)1/47 (2.1)
  peritonitis01/16 (6.3)1/47 (2.1)
a

Meningoencephalitis was confirmed by lumbar puncture.

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