Different Dosing Strategies of Colistin in Multidrug-Resistant Gram-Negative Bacilli Infections

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 25, 2023

Primary Completion Date

September 25, 2025

Study Completion Date

October 25, 2025

Conditions
Critical Ill PatientsMulti Drug Resistant
Interventions
DRUG

EMA colistin dosing strategy

The EMA colistin group will receive I.V colistin based on creatinine clearance (mL/min) level , with fixed loading dose 9 MIU equivalent to 300 mg of colistin-based activity (CBA). The maintenance dose will be administered after 12 h following the loading dose over 1 h every 12h (twice daily).

DRUG

US FDA colistin dosing strategy

The weight-based colistin group will receive I.V. colistin based on the lower (ideal body weight or actual body weight) with a loading dose of (4) X (patient weight in kg). Loading dose might exceed 300 mg.

Trial Locations (1)

Unknown

RECRUITING

King Fahad Specialist Hospital, Buraidah

All Listed Sponsors
lead

Mansoura University

OTHER