NCT01594827: PMEP

Persistent MRSA Eradication Protocol (PMEP)

Completed Phase 2 Results posted Last updated 4 February 2019

What this trial tests

Phase 2 trial testing Inhaled Vancomycin in Cystic Fibrosis in 29 participants. Completed in 30 December 2017.

Timeline

1 October 2012

Primary endpoint
30 December 2017

30 December 2017

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	29
Start date	1 October 2012
Primary completion	30 December 2017
Estimated completion	30 December 2017
Sites	2 locations across United States

Drugs / interventions tested

• Inhaled Vancomycin — full drug profile →
• Placebo (Sterile Water)
• Rifampin — full drug profile →
• Trimethoprim/Sulfamethoxazole (TMP/SMX)
• Doxycycline (doxycycline) — full drug profile →
• Mupirocin Intranasal Creme — full drug profile →
• 4% chlorhexidine gluconate liquid skin cleanser — full drug profile →

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Johns Hopkins University

Who can join

12 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture
  Time frame: Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol
  The hypothesis for our primary outcome is that the aggressive treatment arm will result in significantly greater eradication of persistent MRSA from the respiratory tract of CF adolescents and adults on day 58 (1 month after completion of therapy) compared to the placebo/standard treatment arm. Our primary outcome will be comparing the proportion of CF patients in the treatment arm who have a nega

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical applications of pulmonary delivery of antibiotics.
   Flume PA, VanDevanter DR. · · 2015 · cited 41× · PMID 25453268 · DOI 10.1016/j.addr.2014.10.009
2. Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis.
   Lo DK, Muhlebach MS, Smyth AR. · · 2018 · cited 15× · PMID 30030966 · DOI 10.1002/14651858.cd009650.pub4
3. Eradication strategy for persistent methicillin-resistant Staphylococcus aureus infection in individuals with cystic fibrosis--the PMEP trial: study protocol for a randomized controlled trial.
   Jennings MT, Boyle MP, Weaver D, Callahan KA, et al · · 2014 · cited 15× · PMID 24925006 · DOI 10.1186/1745-6215-15-223
4. Infection prevention and chronic disease management in cystic fibrosis and noncystic fibrosis bronchiectasis.
   Lommatzsch ST. · · 2020 · cited 4× · PMID 32160809 · DOI 10.1177/1753466620905272