Safety and efficacy of simplified antibiotic regimens for outpatient treatment of serious infection in neonates and young infants 0-59 days of age in Bangladesh: design of a randomized controlled trial.
BACKGROUND
Because access to care is limited in settings with high mortality, exclusive reliance on the current recommendation of 7-10 days of parenteral antibiotic treatment is a barrier to provision of adequate treatment of newborn infections.


METHODS
We are conducting a trial to determine if simplified antibiotic regimens with fewer injections are as efficacious as the standard course of parenteral antibiotics for empiric treatment of young infants with clinical signs suggestive of severe infection in 4 urban hospitals and in a rural surveillance site in Bangladesh. The reference regimen of intramuscular procaine-benzyl penicillin and gentamicin given once daily for 7 days is being compared with (1) intramuscular gentamicin once daily and oral amoxicillin twice daily for 7 days and (2) intramuscular penicillin and gentamicin once daily for 2 days followed by oral amoxicillin twice daily for additional 5 days. All regimens are provided in the infant's home. The primary outcome is treatment failure (death or lack of clinical improvement) within 7 days of enrolment. The sample size is 750 evaluable infants enrolled per treatment group, and results will be reported at the end of 2013.


CONCLUSIONS
The trial builds upon previous studies of community case management of clinical severe infections in young infants conducted by our research team in Bangladesh. The approach although effective was not widely accepted in part because of feasibility concerns about the large number of injections. The proposed research that includes fewer doses of parenteral antibiotics if shown efficacious will address this concern.
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA. abaqui@jhsph.edu
Abdullah H
AH
Baqui
Samir Kumar
SK
Saha
A S M Nawshad Uddin
AS
Ahmed
Mohammad
M
Shahidullah
Iftekhar
I
Quasem
Daniel E
DE
Roth
Emma K
EK
Williams
Dipak
D
Mitra
A K M
AK
Shamsuzzaman
Wazir
W
Ahmed
Luke C
LC
Mullany
Simon
S
Cousens
Stephen
S
Wall
Neal
N
Brandes
Robert E
RE
Black
D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001459:Bangladesh; D003153:Community Health Services; D003906:Developing Countries; D004334:Drug Administration Schedule; D015340:Epidemiologic Research Design; D005839:Gentamicins / Q000008:administration & dosage* / Q000009:adverse effects; D006699:Home Care Services; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000188:drug therapy*; D010045:Outpatients; D010402:Penicillin G Procaine / Q000008:administration & dosage* / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D017211:Treatment Failure
D000900:Anti-Bacterial Agents; D005839:Gentamicins; D010402:Penicillin G Procaine; D000658:Amoxicillin