Bekker A
Panjasawatwong N
Hill LF
Stohr W
Walker AS
Ellis S
Dramowski A
Whitelaw A
Obiero C
Berkley JA
Makazi A
Velaphi S
Thomas R
Magagula P
Abrahams I
Nakwa FL
Barday MM
Van Kwawegen A
Pillay K
Gastine S
Standing JF
Skoutari P
Schiavone F
Sharland M
O'Brien S
Bielicki JA
Cressey TR
NeoSep Study Team
Antimicrob Agents Chemother. 2026;70e0112625
Neonatal doses for the off-patent antibiotics fosfomycin and flomoxef, which offer coverage against many extended-spectrum beta-lactamase (ESBL)-producing organisms, are based on limited data. We performed a pharmacokinetic (PK) and safety study of fosfomycin and flomoxef to confirm proposed neonatal dosing before further investigation in a trial (NeoSep1, ISRCTN48721236). Neonates with suspected sepsis, weighing more than 1,000 g, were sequentially enrolled into three antibiotic treatment cohorts: fosfomycin and amikacin (Cohort 1), flomoxef and amikacin (Cohort 2), and flomoxef and fosfomycin (Cohort 3), and followed for 28 days. Plasma samples were taken for PK assessment, with population PK modeling and simulations performed. Sixty-two neonates (48/62 [77%] preterm; 48/62 [77%]
