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Simplified Antibiotic Regimens For Treatment Of Clinical Severe Infection In The Outpatient Setting When Referral Is Not Possible For Young Infants In Pakistan (Simplified Antibiotic Therapy Trial [Satt]): A Randomised, Open-Label, Equivalence Trial, Fatima Mir, Imran Nisar, Shiyam S. Tikmani, Benazir Baloch, Sadia Shakoor, Fyezah Jehan, Imran Ahmed, Simon Cousens, Anita K M Zaidi
Simplified Antibiotic Regimens For Treatment Of Clinical Severe Infection In The Outpatient Setting When Referral Is Not Possible For Young Infants In Pakistan (Simplified Antibiotic Therapy Trial [Satt]): A Randomised, Open-Label, Equivalence Trial, Fatima Mir, Imran Nisar, Shiyam S. Tikmani, Benazir Baloch, Sadia Shakoor, Fyezah Jehan, Imran Ahmed, Simon Cousens, Anita K M Zaidi
Department of Paediatrics and Child Health
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 simplified 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 Simplified Antibiotic Therapy Trial (SATT), a three-arm, randomised, open-label, equivalence trial in five communities in Karachi, Pakistan. We enrolled young infants (aged 0–59 days) who either presented at a primary health-care …