At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Persistent MRSA Eradication Protocol (PMEP)
In Brief
A Phase 2 clinical trial evaluating Inhaled Vancomycin, Placebo (Sterile Water), and 5 other interventions for Cystic Fibrosis. Completed, enrolled 29 participants across 2 sites.
Detailed Summary
The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests that persistent infection with MRSA may result in an increased rate of decline in Forced Expiratory Volume (FEV)1 and shortened survival. Currently there are no conclusive studies demonstrating an effective aggressive treatment protocol for persistent MRSA respiratory infection in CF. Data demonstrating an effective and safe method of clearing persistent MRSA infection are needed. The purpose of this study is to evaluate the safety and efficacy of a 28-day course of vancomycin for inhalation, 250 mg twice a day, (in combination with oral antibiotics) in eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA infection. Subjects will be assigned in a 1:1 ratio to either vancomycin for inhalation (250 mg twice a day) or taste matched placebo and will be followed for 3 additional months. In addition, both groups will receive oral rifampin, a second oral antibiotic (TMP-SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Forty patients with persistent respiratory tract MRSA infection will be enrolled in this trial.
Study Details
Timeline
Interventions
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.
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.
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
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)
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
Mupirocin 2% intranasal creme: half of single use tube applied into each nostril twice a day for 5 days.
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.