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Your journey
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More info
You can access this
clinical trial
if you have
Cystic Fibrosis
and you are
over 12
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: Inhaled Vancomycin
  • Drug: Placebo (Sterile Water)
  • Drug: Rifampin
  • Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX)
  • Drug: Doxycycline
  • Drug: Mupirocin Intranasal Creme
  • Drug: 4% chlorhexidine gluconate liquid skin cleanser

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01594827. The sponsor of the trial is Johns Hopkins University and it is looking for 29 volunteers for the current phase.
Official trial title:
Persistent MRSA Eradication Protocol (PMEP)