Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)

PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

December 30, 2017

Study Completion Date

December 30, 2017

Conditions
Cystic Fibrosis
Interventions
DRUG

Inhaled Vancomycin

On Days 1-28, subjects will receive nebulized Vancomycin. This will be supplied as a 250 mg solution to be nebulized two times a day for 28 days in 5cc sterile water. Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system.

DRUG

Placebo (Sterile Water)

On Days 1-28, subjects will receive 5cc of a nebulized Placebo (Sterile water) twice a day. This is a taste (quinine 0.1mg/mL) matched nebulized placebo (sterile water). Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system.

DRUG

Rifampin

"Oral Rifampin by mouth for 28 days~1. \>45 kg: 600 mg by mouth daily~2. 35-45 kg : 450 mg by mouth daily~3. 25-34.9 kg: 300 mg by mouth daily"

DRUG

Trimethoprim/Sulfamethoxazole (TMP/SMX)

"Oral trimethoprim/sulfamethoxazole (DS-160/800)~1. \>45 kg: two DS tablets twice a day by mouth (320/1600)~2. 25-45 kg: one DS tablet twice a day by mouth (160/800)"

DRUG

Doxycycline

"If sulfa intolerant or TMP/SMX Resistant, use instead oral doxycycline~1. \>45 kg: 100 mg by mouth twice a day~2. 35-45 kg : 75 mg by mouth twice a day iii. 25-34.9 kg: 50 mg by mouth twice a day"

DRUG

Mupirocin Intranasal Creme

Mupirocin 2% intranasal creme: half of single use tube applied into each nostril twice a day for 5 days.

DRUG

4% chlorhexidine gluconate liquid skin cleanser

Hibiclens 15cc liquid skin cleanser packets (4% chlorhexidine gluconate): use three packets once weekly for four weeks in the shower from the neck to toes, with attention on the axilla, groin, and buttocks.

Trial Locations (2)

21205

Johns Hopkins University School of Medicine, Baltimore

44106

Rainbow Babies and Children's Hospital, Cleveland

All Listed Sponsors
collaborator

Case Western Reserve University

OTHER

collaborator

Cystic Fibrosis Foundation

OTHER

lead

Johns Hopkins University

OTHER

NCT01594827 - Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP) | Biotech Hunter | Biotech Hunter