Precision

An observational, prospective pharmacokinetic study looking at colistin in infants and children younger than 2 years.

Sponsored by Stellenbosch University, PRECISION is currently being conducted in the paediatric and neonatal wards at Tygerberg Hospital, South Africa.

Why is PRECISION needed?

Colistin is an antibiotic often prescribed for critically ill newborns, infants and children to treat sepsis caused by resistant bacteria.
However, little research exists on how the drug behaves in their bodies, making it unclear how much is needed for effective treatment, while minimising possible side effects.
Without clear, evidence-based dosing guidelines, these children may receive too little colistin, reducing its effectiveness.
Limited research on colistin’s safety and effectiveness in newborns, infants and children highlights the urgent need for targeted studies to ensure proper dosing of colistin in this patient group.

Study objectives

The PRECISION study aims to improve our understanding of how colistin works in newborns and young children by focusing on three key areas:

How colistin moves through the body. The study will measure colistin levels in children under 2 years after receiving a loading dose to determine how the drug is absorbed, distributed and eliminated.
Patient characteristics and treatment outcomes. It will collect information on the medical conditions of children receiving colistin and assess how well they respond to treatment.
Possible side effects. The study will monitor and document any adverse effects to better understand the safety of colistin in this age group.

Who participates?

All neonates, infants and children under 2 years of age admitted to Tygerberg Hospital (Cape Town) in South Africa, who are prescribed colistin for suspected or confirmed sepsis by the clinician as part of the routine standard of care, are eligible to participate in the PK study.

In the future, we plan to roll-out the study to the Chris Hani Baragwanath Hospital in Johannesburg, South Africa to increase enrolment.

As of May 2025, 4 newborns and 2 infants have been enrolled in the study.

Impact

Colistin is a last-line antibiotic to treat very resistant bacteria.

If not dosed appropriately, bacteria can become resistant to colistin with very few alternative effective antibiotics available.

This study will improve our knowledge on how to dose colistin more appropriately in neonates, infants and children under 2 years.