Scientific rationale for study design of community-based simplified antibiotic therapy trials in newborns and young infants with clinically diagnosed severe infections or fast breathing in South Asia and sub-Saharan Africa.
BACKGROUND
Newborns and young infants suffer high rates of infections in South Asia and sub-Saharan Africa. Timely access to appropriate antibiotic therapy is essential for reducing mortality. In an effort to develop community case management guidelines for young infants, 0-59 days old, with clinically diagnosed severe infections, or with fast breathing, 4 trials of simplified antibiotic therapy delivered in primary care clinics (Pakistan, Democratic Republic of Congo, Kenya and Nigeria) or at home (Bangladesh and Nigeria) are being conducted.


METHODS
This article describes the scientific rationale for these trials, which share major elements of trial design. All the trials are in settings of high neonatal mortality, where hospitalization is not feasible or frequently refused. All use procaine penicillin and gentamicin intramuscular injections for 7 days as reference therapy and compare this to various experimental arms utilizing comparatively simpler combination regimens with fewer injections and oral amoxicillin.


CONCLUSIONS
The results of these trials will inform World Health Organization policy regarding community case management of young infants with clinical severe infections or with fast breathing.
Aga Khan University, Karachi, Pakistan.
Anita K M
AK
Zaidi
Abdullah H
AH
Baqui
Shamim Ahmad
SA
Qazi
Rajiv
R
Bahl
Samir
S
Saha
Adejumoke I
AI
Ayede
Ebunoluwa A
EA
Adejuyigbe
Cyril
C
Engmann
Fabian
F
Esamai
Antoinette Kitoto
AK
Tshefu
Robinson D
RD
Wammanda
Adegoke G
AG
Falade
Adetanwa
A
Odebiyi
Peter
P
Gisore
Adrien Lokangaka
AL
Longombe
William N
WN
Ogala
Shiyam Sundar
SS
Tikmani
A S M Nawshad
AS
Uddin Ahmed
Steve
S
Wall
Neal
N
Brandes
Daniel E
DE
Roth
Gary L
GL
Darmstadt
D017954:Africa South of the Sahara; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000188:drug therapy; D001459:Bangladesh; D003153:Community Health Services; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000188:drug therapy*; D010154:Pakistan; D016032:Randomized Controlled Trials as Topic; D059246:Tachypnea / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D017211:Treatment Failure
D000900:Anti-Bacterial Agents