Simplifi ed antibiotic regimens for treatment of clinical severe infection in the outpatient setting when referral is not possible for young infants in Pakistan (Simplifi ed Antibiotic Therapy Trial [SATT]): a randomised, open-label, equivalence trial

Mir, Fatima and Nisar, Imran and S Tikmani, Shiyam and Baloch, Benazir and Shakoor, Sadia and Jehan, Fyezah and Ahmed, Imran and Cousens, Simon and K M Zaidi, Anita (2017) Simplifi ed antibiotic regimens for treatment of clinical severe infection in the outpatient setting when referral is not possible for young infants in Pakistan (Simplifi ed Antibiotic Therapy Trial [SATT]): a randomised, open-label, equivalence trial. The Lancet Global Health, 5 (2). e177-e185. ISSN 0140-6736

[img] Text
PIIS2214109X16303357.pdf

Download (350kB)
Official URL: http://www.thelancet.com/journals/langlo/article/P...

Abstract

Background Parenteral antibiotic therapy for young infants (aged 0–59 days) with suspected sepsis is sometimes not available or feasible in countries with high neonatal mortality. Outpatient treatment could save lives in such settings. We aimed to assess the equivalence of two simplifi ed antibiotic regimens, comprising fewer injections and oral rather than parenteral administration, compared with a reference treatment for young infants with clinical severe infection. Methods We undertook the Simplifi ed Antibiotic Therapy Trial (SATT), a three-arm, randomised, open-label, equivalence trial in fi ve communities in Karachi, Pakistan. We enrolled young infants (aged 0–59 days) who either presented at a primary health-care clinic or were identifi ed by a community health worker with signs of clinical severe infection. We included infants who were not critically ill and whose family refused admission. We randomly assigned infants to either intramuscular procaine benzylpenicillin and gentamicin once a day for 7 days (reference); oral amoxicillin twice daily and intramuscular gentamicin once a day for 7 days; or intramuscular procaine benzylpenicillin and gentamicin once a day for 2 days followed by oral amoxicillin twice daily for 5 days. The primary outcome was treatment failure within 7 days of enrolment and the primary analysis was per protocol. We judged experimental treatments as effi cacious as the reference if the upper bound of the 95% CI for the diff erence in treatment failure was less than 5·0. This trial is registered at ClinicalTrials.gov, number NCT01027429. Findings Between Jan 1, 2010, and Dec 26, 2013, 2780 infants were deemed eligible for the trial, of whom 2453 (88%) were enrolled. Because of inadequate clinical follow-up or treatment adherence, 2251 infants were included in the per-protocol analysis. 820 infants (747 per protocol) were assigned the reference treatment of procaine benzylpenicillin and gentamicin, 816 (751 per protocol) were allocated amoxicillin and gentamicin, and 817 (753 per protocol) were assigned procaine benzylpenicillin, gentamicin, and amoxicillin. Treatment failure within 7 days of enrolment was reported in 90 (12%) infants who received procaine benzylpenicillin and gentamicin (reference), 76 (10%) of those given amoxicillin and gentamicin (risk diff erence with reference –1·9, 95% CI –5·1 to 1·3), and 99 (13%) of those treated with procaine benzylpenicillin, gentamicin, and amoxicillin (risk diff erence with reference 1·1, –2·3 to 4·5). Interpretation Two simplifi ed antibiotic regimens requiring fewer injections are equivalent to a reference treatment for young infants with signs of clinical severe infection but without signs of critical illness. The use of these simplifi ed regimens has the potential to increase access to treatment for sick young infants who cannot be referred to hospital.

Item Type: Article
Subjects: WA Public Health
Divisions: Faculty of Medicin
Depositing User: Touba Derakhshande
Date Deposited: 13 Sep 2017 05:00
Last Modified: 13 Sep 2017 05:00
URI: http://eprints.bpums.ac.ir/id/eprint/5970

Actions (login required)

View Item View Item