TY - JOUR
T1 - Short-course antibiotic treatment for community-acquired alveolar pneumonia in ambulatory children
T2 - A double-blind, randomized, placebo-controlled trial
AU - Greenberg, David
AU - Givon-Lavi, Noga
AU - Sadaka, Yair
AU - Ben-Shimol, Shalom
AU - Bar-Ziv, Jacob
AU - Dagan, Ron
PY - 2014/1/1
Y1 - 2014/1/1
N2 - BACKGROUND:: Studies on short-course treatment of childhood pneumonia in the developed world are lacking. We compared clinical and laboratory outcomes of a 3-day or a 5-day to a 10-day treatment in young children with community-acquired alveolar pneumonia. METHODS:: A double-blind, randomized, placebo-controlled trial was conducted in 2 stages: (1) 3 days versus 10 days and (2) 5 days versus 10 days. Amoxicillin (80 mg/kg/d; divided into 3 daily doses) was used for all arms. Case definition was: age 6-59 months; radiologically confirmed community-acquired alveolar pneumonia; temperature ≥38.5 C; peripheral white blood cell count ≥15,000/mm; status permitting outpatient treatment. Scheduled visits were on days 4-5 and 10-14 with daily telephone interviews for 30 days. Treatment failure was defined by the need for a rescue treatment or hospitalization. Secondary outcomes were: duration of fever and symptoms and white blood cell and C-reactive protein responses. RESULTS:: During Stage 1, 4/10 (40%) and 0/12 (0%) evaluable patients failed in the 3-day and 10-day arms, respectively (P = 0.16). Therefore, the 3-day arm was replaced by a 5-day arm (Stage 2). No failures occurred in the 5-day (n = 56) and 10-day (n = 59) arms. Overall, 4/10 (0%), 0/56 and 0/42 (0%) children failed in the 3-day, 5-day and 10-day arms, respectively (P < 0.001, 3-day versus 5-day or 10-day). Secondary outcomes were similar in the 5-day and 10-day arms. CONCLUSION:: In 6- to 59-month-old outpatients with community-acquired alveolar pneumonia, a 5-day course with high-dose oral amoxicillin was not inferior to a 10-day course. The 3-day regimen may be associated with an unacceptable failure rate.
AB - BACKGROUND:: Studies on short-course treatment of childhood pneumonia in the developed world are lacking. We compared clinical and laboratory outcomes of a 3-day or a 5-day to a 10-day treatment in young children with community-acquired alveolar pneumonia. METHODS:: A double-blind, randomized, placebo-controlled trial was conducted in 2 stages: (1) 3 days versus 10 days and (2) 5 days versus 10 days. Amoxicillin (80 mg/kg/d; divided into 3 daily doses) was used for all arms. Case definition was: age 6-59 months; radiologically confirmed community-acquired alveolar pneumonia; temperature ≥38.5 C; peripheral white blood cell count ≥15,000/mm; status permitting outpatient treatment. Scheduled visits were on days 4-5 and 10-14 with daily telephone interviews for 30 days. Treatment failure was defined by the need for a rescue treatment or hospitalization. Secondary outcomes were: duration of fever and symptoms and white blood cell and C-reactive protein responses. RESULTS:: During Stage 1, 4/10 (40%) and 0/12 (0%) evaluable patients failed in the 3-day and 10-day arms, respectively (P = 0.16). Therefore, the 3-day arm was replaced by a 5-day arm (Stage 2). No failures occurred in the 5-day (n = 56) and 10-day (n = 59) arms. Overall, 4/10 (0%), 0/56 and 0/42 (0%) children failed in the 3-day, 5-day and 10-day arms, respectively (P < 0.001, 3-day versus 5-day or 10-day). Secondary outcomes were similar in the 5-day and 10-day arms. CONCLUSION:: In 6- to 59-month-old outpatients with community-acquired alveolar pneumonia, a 5-day course with high-dose oral amoxicillin was not inferior to a 10-day course. The 3-day regimen may be associated with an unacceptable failure rate.
UR - http://www.scopus.com/inward/record.url?scp=84892959471&partnerID=8YFLogxK
U2 - 10.1097/INF.0000000000000023
DO - 10.1097/INF.0000000000000023
M3 - Article
C2 - 23989106
AN - SCOPUS:84892959471
SN - 0891-3668
VL - 33
SP - 136
EP - 142
JO - Pediatric Infectious Disease Journal
JF - Pediatric Infectious Disease Journal
IS - 2
ER -