TEFLARO® ABSSSI study in pediatric patients 2 months to less than 18 years: Selected patient demographics and baseline characteristic (MITT)4 | ||
Characteristics |
TEFLARO (N=107) |
Vancomycin or Cefazolin (N=52) |
Age range (years) | (0.2-17.0) | (0.6-17.0) |
Male sex (%) | 57 (53.3) | 31 (59.6) |
BMI* (kg/mg2) range | (11.6-32.2) | (11.2-27.7) |
Infection type n (%) | ||
Deep/extensive cellulitis or erysipelas | 69 (64.5) | 36 (69.2) |
Major abscess | 27 (25.2) | 12 (23.1) |
Infected wound | 11 (10.3) | 4 (7.7) |
Site of primary infection n (%) | ||
Legs | 32 (29.9) | 21 (40.4) |
Buttocks | 17 (15.9) | 6 (11.5) |
Head | 10 (9.3) | 9 (17.3) |
Groin | 10 (9.3) | 1 (1.9) |
Feet | 8 (7.5) | 7 (13.5) |
Hands | 8 (7.5) | 4 (7.7) |
Arms | 7 (6.5) | 4 (7.7) |
Chest | 7 (6.5) | 1 (1.9) |
Neck | 6 (5.6) | 2 (3.8) |
Abdomen | 5 (4.7) | 0 (0.0) |
Lower back | 3 (2.8) | 1 (1.9) |
ABSSSI requires significant surgical intervention within <48 hours n (%) | 16 (15.0) | 6 (11.5) |
Infection area (cm2) Median (range) |
108.0 (3.8-742.5) |
111.8 (19.3-874.0) |
Enrolled as a treatment failure n (%) | 9 (8.4) | 5 (9.6) |
>1 prior antibacterial† | ||
Within 96 h prior to randomization n (%) | 71 (66.4) | 35 (67.3) |
≤24 h of prior treatment n (%) | 60 (56.1) | 30 (57.7) |
>24 h of prior treatment n (%) | 11 (10.3) | 5 (9.6) |
Systemic signs of infection n (%) | ||
Fever (>38°C) | 61 (57.0) | 31 (59.6) |
Elevated WBC (>12,000 cells/mm3) | 72 (67.3) | 32 (61.5) |
Elevated band neutrophils (>10%) | 11 (10.3) | 4 (7.7) |
Presence of bacteremia | 1 (0.9) | 0 (0.0) |
TEFLARO® ABSSSI study in pediatric patients 2 months to less than 18 years: Selected patient demographics and baseline characteristic (MITT)4 | |
Characteristics | |
TEFLARO (N=107) |
Vancomycin or Cefazolin (N=52) |
Age range (years) | |
(0.2-17.0) | (0.6-17.0) |
Male sex (%) | |
57 (53.3) | 31 (59.6) |
BMI* (kg/mg2) range | |
(11.6-32.2) | (11.2-27.7) |
Infection type n (%) | |
Deep/extensive cellulitis or erysipelas | |
69 (64.5) | 36 (69.2) |
Major abscess | |
27 (25.2) | 12 (23.1) |
Infected wound | |
11 (10.3) | 4 (7.7) |
Site of primary infection n (%) | |
Legs | |
32 (29.9) | 21 (40.4) |
Buttocks | |
17 (15.9) | 6 (11.5) |
Head | |
10 (9.3) | 9 (17.3) |
Groin | |
10 (9.3) | 1 (1.9) |
Feet | |
8 (7.5) | 7 (13.5) |
Hands | |
8 (7.5) | 4 (7.7) |
Arms | |
7 (6.5) | 4 (7.7) |
Chest | |
7 (6.5) | 1 (1.9) |
Neck | |
6 (5.6) | 2 (3.8) |
Abdomen | |
5 (4.7) | 0 (0.0) |
Lower back | |
3 (2.8) | 1 (1.9) |
ABSSSI requires significant surgical intervention within <48 hours n (%) |
|
16 (15.0) | 6 (11.5) |
Infection area (cm2) Median (range) |
|
108.0 (3.8-742.5) |
111.8 (19.3-874.0) |
Enrolled as a treatment failure n (%) |
|
9 (8.4) | 5 (9.6) |
>1 prior antibacterial† | |
Within 96 h prior to
randomization, n (%) |
|
71 (66.4) | 35 (67.3) |
≤24 h of prior treatment n (%) | |
60 (56.1) | 30 (57.7) |
>24 h of prior treatment n (%) | |
11 (10.3) | 5 (9.6) |
Systemic signs of infection n (%) | |
Fever (>38°C) | |
61 (57.0) | 31 (59.6) |
Elevated WBC (>12,000 cells/mm3) |
|
72 (67.3) | 32 (61.5) |
Elevated band neutrophils (>10%) |
|
11 (10.3) | 4 (7.7) |
Presence of bacteremia | |
1 (0.9) | 0 (0.0) |
BMI data missing for one patient in the ceftaroline fosamil group.
Prior systemic antibacterial medications received within 96 h before first dose of IV study drug.
ABSSSI=acute bacterial skin and skin structure infection; MITT=modified intent-to-treat; BMI=body mass index; WBC=white blood cell.
Data on file. Allergan, Inc.
An additional single study enrolled 11 pediatric patients with a gestational age of ≥34 weeks and a postnatal age of 12 days to less than 2 months of age with known or suspected infections. The majority of patients (8 of 11) received 6 mg/kg TEFLARO every 8 hours as an intravenous (IV) infusion over 60 minutes.1
Learn about TEFLARO dosing in pediatric patients based on age and weight
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Please also see full Prescribing Information.