Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)

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.

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.

Sponsors & Collaborators

• Case Western Reserve University

  collaborator OTHER

• Cystic Fibrosis Foundation

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Michael P Boyle, MD · Johns Hopkins School of Medicine

• James Chmiel, MD · Case Western University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2017-12-30

Completion

2017-12-30

Countries

• United States

Study Locations