Multi-Drug Resistant Organism Network

This is a prospective multi-center study. At each hospital, study personnel will screen the
microbiology laboratory logs to identify all patients found to have a MDRO isolate from one
or more anatomical sites during hospitalization. For each patient identified, designated site
personnel will access the patient's medical record and use web-based data entry to enter the
relevant data into the electronic case report form (eCRF) in the study's centralized
database.

A sample of all MDRO isolates (bacterial isolates) will be sent to a central research
laboratory for molecular analysis which will include strain typing. In addition, the
mechanism of resistance will be determined by performing PCR.

Aim 1. Identification of target population and high volume centers. The prevalence of
specific MDRO is extremely variable in various patient populations. In addition, over time,
prevalence patterns for specific MDRO tend to change. The data collection carried out under
this protocol will provide real-time data on which patients are the target population for any
trial directed against MDRO infection. Also, the data collected will indicate which
geographic areas and which centers have the highest incidence of MDRO infections. This will
facilitate rational site selection for future trials.

Aim 2. Provide data on impact of potential inclusion/exclusion criteria on enrollment in
future trials.

Detailed clinical data will be collected to guide the future development of clinical trials.
The eCRF is designed to collect data on the most common barriers to enrollment in clinical
trials. Data can then be used in the design of future trials to be presented to
pharmaceutical companies, as well as to regulators from the FDA, to provide a rationale for
requesting exceptions in inclusion/exclusion criteria. This will result in clinical trials
that are more readily generalizable.

Aim 3. Provide data on expected outcomes of patients with MDRO infections for power and
sample size calculations for future trials.

In the MDRO network, detailed outcomes data will be collected. Data will include survival and
microbiologic clearance outcomes when available. In addition, anatomical site specific
clinical symptomatic outcomes, modeled on FDA guidance documents, will be documented. Data
obtained will aid in guiding the design of future clinical trials by providing data needed
for power and sample size calculations.

All hospitalized patients, including pediatric patients, who have an MDRO isolated from a
clinical culture will be included. Patients who have a positive culture for MDRO that is
obtained outside the hospital setting will not be included, to ensure the ability to collect
MDRO isolates and sufficient clinical data. Overall enrollment is expected to be 5199.

This study will request a waiver of informed consent, consistent with CFR Title 45 part
46.116(d). The study does not involve direct interaction with human subjects. The medical
records of patients admitted to the hospital will be screened and data collected from those
records according this protocol. The patients will not be approached to obtain information,
no intervention is being tested. MDRO isolates will be obtained from existing standard of
care microbial testing.

Inclusion Criteria:

- Hospitalized patients.

- Must have at least one multi-drug resistant organism isolated from a clinical culture
while hospitalized.

Exclusion Criteria:

- Patients who do not have a positive culture during hospitalization.

- Patients who's only positive culture was obtained outside of hospital admission
admission.