Randomised controlled trial of fosfomycin in neonatal sepsis: pharmacokinetics and safety in relation to sodium overload.

ABSTRACT:

Objective

To assess pharmacokinetics and changes to sodium levels in addition to adverse events (AEs) associated with fosfomycin among neonates with clinical sepsis.

Design

A single-centre open-label randomised controlled trial.

Setting

Kilifi County Hospital, Kenya.

Patients

120 neonates aged ≤28 days admitted being treated with standard-of-care (SOC) antibiotics for sepsis: ampicillin and gentamicin between March 2018 and February 2019.

Intervention

We randomly assigned half the participants to receive additional intravenous then oral fosfomycin at 100 mg/kg two times per day for up to 7 days (SOC-F) and followed up for 28 days.

Main outcomes and measures

Serum sodium, AEs and fosfomycin pharmacokinetics.

Results

61 and 59 infants aged 0-

SUBMITTER: Obiero CW 

PROVIDER: S-EPMC9411916 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature