Safety and efficacy of alternative antibiotic regimens compared with 7 day injectable procaine benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible: A randomised, open-label, equivalence trial

Projahnmo Study Group in Bangladesh, Dipak K. Mitra

Research output: Contribution to journalArticle

Abstract

Background: Severe infections remain one of the main causes of neonatal deaths worldwide. Possible severe infection is diagnosed in young infants (aged 0-59 days) according to the presence of one or more clinical signs. The recommended treatment is hospital admission with 7-10 days of injectable antibiotic therapy. In low-income and middle-income countries, barriers to hospital care lead to delayed, inadequate, or no treatment for many young infants. We aimed to identify effective alternative antibiotic regimens to expand treatment options for situations where hospital admission is not possible. Methods: We did this randomised, open-label, equivalence trial in four urban hospitals and one rural field site in Bangladesh to determine whether two alternative antibiotic regimens with reduced numbers of injectable antibiotics combined with oral antibiotics had similar efficacy and safety to the standard regimen, which was also used as outpatient treatment. We randomly assigned infants who showed at least one clinical sign of severe, but not critical, infection (except fast breathing alone), whose parents refused hospital admission, to one of the three treatment regimens. We stratified randomisation by study site and age (

Original languageEnglish (US)
Pages (from-to)e279-e287
JournalThe Lancet Global Health
Volume3
Issue number5
DOIs
StatePublished - May 1 2015

Fingerprint

Penicillin G Procaine
Gentamicins
Outpatients
Referral and Consultation
Newborn Infant
Anti-Bacterial Agents
Safety
Injections
Infection
Therapeutics
Bangladesh
Urban Hospitals
Random Allocation
Cause of Death
Respiration
Parents

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{2a9df1e4445c4deaa4a408399a3cdd84,
title = "Safety and efficacy of alternative antibiotic regimens compared with 7 day injectable procaine benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible: A randomised, open-label, equivalence trial",
abstract = "Background: Severe infections remain one of the main causes of neonatal deaths worldwide. Possible severe infection is diagnosed in young infants (aged 0-59 days) according to the presence of one or more clinical signs. The recommended treatment is hospital admission with 7-10 days of injectable antibiotic therapy. In low-income and middle-income countries, barriers to hospital care lead to delayed, inadequate, or no treatment for many young infants. We aimed to identify effective alternative antibiotic regimens to expand treatment options for situations where hospital admission is not possible. Methods: We did this randomised, open-label, equivalence trial in four urban hospitals and one rural field site in Bangladesh to determine whether two alternative antibiotic regimens with reduced numbers of injectable antibiotics combined with oral antibiotics had similar efficacy and safety to the standard regimen, which was also used as outpatient treatment. We randomly assigned infants who showed at least one clinical sign of severe, but not critical, infection (except fast breathing alone), whose parents refused hospital admission, to one of the three treatment regimens. We stratified randomisation by study site and age (",
author = "{Projahnmo Study Group in Bangladesh} and Abdullah Baqui and Saha, {Samir K.} and Ahmed, {A. S M Nawshad Uddin} and Mohammad Shahidullah and Iftekhar Quasem and Roth, {Daniel E.} and Samsuzzaman, {A. K M} and Wazir Ahmed and Mitra, {Dipak K.} and Mitra, {Dipak K.} and Nazma Begum and Maksuda Islam and Arif Mahmud and Rahman, {M Hafizur} and Moin, {Mamun Ibne} and Mullany, {Luke C} and Simon Cousens and {El Arifeen}, Shams and Stephen Wall and Neal Brandes and Mathuram Santosham and Black, {Robert E}",
year = "2015",
month = "5",
day = "1",
doi = "10.1016/S2214-109X(14)70347-X",
language = "English (US)",
volume = "3",
pages = "e279--e287",
journal = "The Lancet Global Health",
issn = "2214-109X",
publisher = "Elsevier BV",
number = "5",

}

TY - JOUR

T1 - Safety and efficacy of alternative antibiotic regimens compared with 7 day injectable procaine benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible

T2 - A randomised, open-label, equivalence trial

AU - Projahnmo Study Group in Bangladesh

AU - Baqui, Abdullah

AU - Saha, Samir K.

AU - Ahmed, A. S M Nawshad Uddin

AU - Shahidullah, Mohammad

AU - Quasem, Iftekhar

AU - Roth, Daniel E.

AU - Samsuzzaman, A. K M

AU - Ahmed, Wazir

AU - Mitra, Dipak K.

AU - Mitra, Dipak K.

AU - Begum, Nazma

AU - Islam, Maksuda

AU - Mahmud, Arif

AU - Rahman, M Hafizur

AU - Moin, Mamun Ibne

AU - Mullany, Luke C

AU - Cousens, Simon

AU - El Arifeen, Shams

AU - Wall, Stephen

AU - Brandes, Neal

AU - Santosham, Mathuram

AU - Black, Robert E

PY - 2015/5/1

Y1 - 2015/5/1

N2 - Background: Severe infections remain one of the main causes of neonatal deaths worldwide. Possible severe infection is diagnosed in young infants (aged 0-59 days) according to the presence of one or more clinical signs. The recommended treatment is hospital admission with 7-10 days of injectable antibiotic therapy. In low-income and middle-income countries, barriers to hospital care lead to delayed, inadequate, or no treatment for many young infants. We aimed to identify effective alternative antibiotic regimens to expand treatment options for situations where hospital admission is not possible. Methods: We did this randomised, open-label, equivalence trial in four urban hospitals and one rural field site in Bangladesh to determine whether two alternative antibiotic regimens with reduced numbers of injectable antibiotics combined with oral antibiotics had similar efficacy and safety to the standard regimen, which was also used as outpatient treatment. We randomly assigned infants who showed at least one clinical sign of severe, but not critical, infection (except fast breathing alone), whose parents refused hospital admission, to one of the three treatment regimens. We stratified randomisation by study site and age (

AB - Background: Severe infections remain one of the main causes of neonatal deaths worldwide. Possible severe infection is diagnosed in young infants (aged 0-59 days) according to the presence of one or more clinical signs. The recommended treatment is hospital admission with 7-10 days of injectable antibiotic therapy. In low-income and middle-income countries, barriers to hospital care lead to delayed, inadequate, or no treatment for many young infants. We aimed to identify effective alternative antibiotic regimens to expand treatment options for situations where hospital admission is not possible. Methods: We did this randomised, open-label, equivalence trial in four urban hospitals and one rural field site in Bangladesh to determine whether two alternative antibiotic regimens with reduced numbers of injectable antibiotics combined with oral antibiotics had similar efficacy and safety to the standard regimen, which was also used as outpatient treatment. We randomly assigned infants who showed at least one clinical sign of severe, but not critical, infection (except fast breathing alone), whose parents refused hospital admission, to one of the three treatment regimens. We stratified randomisation by study site and age (

UR - http://www.scopus.com/inward/record.url?scp=84927911880&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84927911880&partnerID=8YFLogxK

U2 - 10.1016/S2214-109X(14)70347-X

DO - 10.1016/S2214-109X(14)70347-X

M3 - Article

C2 - 25841891

AN - SCOPUS:84927911880

VL - 3

SP - e279-e287

JO - The Lancet Global Health

JF - The Lancet Global Health

SN - 2214-109X

IS - 5

ER -