Cotrimoxazole Versus Vancomycin for Invasive Methicillin-resistant Staphylococcus Aureus Infections

PHASE3CompletedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

May 31, 2014

Study Completion Date

June 30, 2014

Conditions
Staphylococcal InfectionsMeningitisSepsisPneumonia
Interventions
DRUG

Cotrimoxazole

Cotrimoxazole arm: intravenous cotrimoxazole 4 amp (320 mg trimethoprim/ 1600 mg sulfamethoxazole) diluted in 500 ml D5W or N.S. Q 12 hours. Patients intolerant of volume overload will be given the same dose in 250ml D5W (as in the current recommendations used in the hospital). The dose was selected basing on the existing randomized controlled trial and a pharmacokinetic study . 21 For patients with GFR\< 30 the dosage interval will be increased to 4 amp (320 mg trimethoprim/ 1600 mg sulfamethoxazole) diluted in 500 ml D5W or N.S. Q 24 hours. 22 Patients on peritoneal dialysis will be given 2 amp (160 mg trimethoprim/ 800 mg sulfamethoxazole) Q 48 hours. Patients with acute renal failure treated with hemodialysis will be given the 2 amp (160 mg trimethoprim/ 800 mg sulfamethoxazole) after dialysis. Patients on continuous hemofiltration for acute renal failure will be administered the dose for GFR\<30.

DRUG

Vancomycin

intravenous vancomycin 1gr Q 12 hours. Adjustment to creatinine clearance: GFR 10-50 1 gr Q 24-96 hours, GFR \<10 1gr Q 4-7 days.

Trial Locations (2)

49100

Rabin Medical Center; Beilinson Hospital and Davidoff Cancer Center, Petah Tikva

Unknown

Rambam Health Care Campus, Haifa

All Listed Sponsors
lead

Rabin Medical Center

OTHER

NCT00427076 - Cotrimoxazole Versus Vancomycin for Invasive Methicillin-resistant Staphylococcus Aureus Infections | Biotech Hunter | Biotech Hunter