Early MRSA therapy in CF - culture based vs. observant therapy (treat or observe) (STAR-too - STaph Aureus Resistance - treat or observe)

Study ID
STU 052012-095

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Preeti Sharma
214-456-4630
preeti.sharma@utsouthwestern.edu

Principal Investigator
Preeti Sharma

Summary

This is a randomized, open-label, multi-center trial in CF patients with new MRSa isolated from the
respiratory tract. The study will compare use of a two week eradication treatment protocol to an
observational group who will be treated for MRSa only when respiratory symptoms meet the
criteria for a protocol defined pulmonary exacerbation during the first 28 days of the study. all
subjects will continue to be followed and observed through six months. ninety (90) subjects with
new MRSa infection will be randomized in a 1:1 fashion to either the treatment arm or to the
observational control arm. Randomization will be stratified by age and P. aeruginosa status at
screening. each subject randomized to the treatment arm will receive two oral antibiotics for 14
days, topical anti-bacterial treatment of skin and nares, and a three week environmental
decontamination for high risk areas and equipment. each subject randomized to the observational
control arm will be followed clinically with usual care except to treat new or worsening pulmonary symptoms with antibiotics between screening and Day 28 only when subjects meet criteria for a
protocol defined exacerbation.
Total duration of an individual subject's participation will be six months. Total duration of the study
is expected to be 21 months.

Participant Eligibility

1. Male or female >= 4 and <= 45 years of age at the Screening Visit.
2. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with
the CF phenotype and one or more of the following criteria:
a. sweat chloride >= 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
b. two well-characterized mutations in the cystic fibrosis transmembrane conductive
regulator (CFTR) gene
c. Abnormal nasal potential difference (change in NPD in response to a low chloride
solution and isoproteronol of less than -5 mV)
3. MRSA isolated from the respiratory tract (sputum or OP) at screening, OR at the most recent
clinical care visit that occurred within six (6) months prior to screening AND the MRSA isolate
is available for susceptibility testing
4. First OR early MRSA colonization defined as:
a. First MRSA colonization: first documented isolation of MRSA from respiratory tract
occurred <= 6 months prior to screening
OR
b. Early MRSA colonization:

* MRSA was previously isolated from the respiratory tract <= 2 times over the
past 3.5 years, but this was followed by at least 1 year of documented
negative cultures for MRSA as noted below:
a. At least 2 cultures performed at least 3 months apart to
document 1 year of culture negativity. Each of these cultures
should be documented to have been collected at least 1 week
after end of any antibiotic prescription with MRSA activity.

* Patient again recently positive for MRSA from the respiratory tract (within 6
5. Clinically stable with no significant changes in health status within the 14 days prior to
screening
6. Written informed consent (and assent when applicable) obtained from subject or subject[Single Quote]s legal
representative and ability for subject to comply with the requirements of the study

The sponsor recognizes that inclusion criteria # 4 is missing in the protocol. This will be updated in the next protocol amendment, but is not currently available at this time.