Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants

Summary

The objective of this trial is 1) to evaluate the safety and clinical acceptability of a 5-day course of mupirocin applied every 8 hours (± 2 hours) to the nares, umbilical and perianal areas of infants residing in the ICU. 2) to examine the efficacy of mupirocin in eradicating SA colonization of infants in the ICU, defined as the absence of SA in cultures of the nares, umbilical, and perianal areas on day 8 (± 2) (primary decolonization) 3) to examine the efficacy of mupirocin in achieving persistent eradication of SA colonization among infants residing in the ICU,defined as the absence of SA in cultures of the nares, umbilical, and perianal areas. Duration is 36 months. Enrolled infants will continue to receive medical care as they otherwise would if they were not enrolled in the trial. The study will be powered with a primary endpoint with 126 participants. Enrollment may continue to 500 participants to power secondary and exploratory endpoints and assist design subsequent studies.

Timeline

Start

2014-04-30

Primary completion

2016-06-07

Completion

2016-06-21

Publications

• Kotloff KL, Shirley DT, Creech CB, Frey SE, Harrison CJ, Staat M, Anderson EJ, Dulkerian S, Thomsen IP, Al-Hosni M, Pahud BA, Bernstein DI, Yi J, Petrikin JE, Haberman B, Stephens K, Stephens I, Oler RE Jr, Conrad TM. Mupirocin for Staphylococcus aureus Decolonization of Infants in Neonatal Intensive Care Units. Pediatrics. 2019 Jan;143(1):e20181565. doi: 10.1542/peds.2018-1565.

Drugs

Indications