Antibiotic Resistance in Global Pediatric Oncology Centers
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 3/30/2019 |
| Start Date: | February 26, 2019 |
| End Date: | April 30, 2020 |
| Contact: | Sheena Mukkada, MD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5835 |
Antibiotic resistance is one of the major health threats facing global as well as domestic
populations, however it is not well characterized in pediatric patients. Pediatric patients
receiving cancer-directed therapy have several risk factors implicated in development of
antibiotic resistance including multiple courses of antibiotics, repeated exposures to the
hospital environment, indwelling devices and chemotherapy-related damage to mucosal barriers.
The investigators propose to capitalize upon the unique position of St. Jude Global within
the global pediatric oncology community by using its regional alliance network to describe
the molecular epidemiology of antibiotic resistance in Gram-negative bacteria in this
population.
Primary Objectives
1. Describe the epidemiology and the phenotypic and previously determined molecular
determinants of antimicrobial resistance in Gram-negative organisms isolated from
pediatric diagnostic specimens in selected Central American and US sites with capacity
to treat pediatric cancer
2. Utilize strain typing by whole genome sequencing to describe relatedness between
organisms at participating sites
populations, however it is not well characterized in pediatric patients. Pediatric patients
receiving cancer-directed therapy have several risk factors implicated in development of
antibiotic resistance including multiple courses of antibiotics, repeated exposures to the
hospital environment, indwelling devices and chemotherapy-related damage to mucosal barriers.
The investigators propose to capitalize upon the unique position of St. Jude Global within
the global pediatric oncology community by using its regional alliance network to describe
the molecular epidemiology of antibiotic resistance in Gram-negative bacteria in this
population.
Primary Objectives
1. Describe the epidemiology and the phenotypic and previously determined molecular
determinants of antimicrobial resistance in Gram-negative organisms isolated from
pediatric diagnostic specimens in selected Central American and US sites with capacity
to treat pediatric cancer
2. Utilize strain typing by whole genome sequencing to describe relatedness between
organisms at participating sites
Participating clinical microbiology laboratories will flag any Gram-negative bacteria meeting
inclusion criteria. Bacteria will be subcultured; one sample will be lysed and shipped to St.
Jude, the remaining sample will be stored onsite for the duration of the study. Samples of
bacteria from both oncology and non-oncology patients will be included. Whole genome
sequencing will be performed on the bacterial samples at St. Jude and the genotypic and
phenotypic antimicrobial resistance testing (AST) results compared. Genotypic results will
additionally be used to describe phylogenetic relationships and potential transmission events
both within and between sites.
Each participating location will collect limited clinical data corresponding to disease and
treatment related factors on the affected patient. This will include sociodemographic
variables, oncologic diagnosis, treatment phase, presence of a central venous catheter or
other foreign body, antibiotic treatment within the past month, and previous history of
colonization or infection by a resistant organism.
inclusion criteria. Bacteria will be subcultured; one sample will be lysed and shipped to St.
Jude, the remaining sample will be stored onsite for the duration of the study. Samples of
bacteria from both oncology and non-oncology patients will be included. Whole genome
sequencing will be performed on the bacterial samples at St. Jude and the genotypic and
phenotypic antimicrobial resistance testing (AST) results compared. Genotypic results will
additionally be used to describe phylogenetic relationships and potential transmission events
both within and between sites.
Each participating location will collect limited clinical data corresponding to disease and
treatment related factors on the affected patient. This will include sociodemographic
variables, oncologic diagnosis, treatment phase, presence of a central venous catheter or
other foreign body, antibiotic treatment within the past month, and previous history of
colonization or infection by a resistant organism.
Inclusion Criteria:
- Pediatric (0-18 years of age) patients having a bacteria isolated from a sterile site
(blood, cerebrospinal fluid, body fluid) or urine positive for a Gram-negative
bacteria nonsusceptible to at least 1 of the following: third generation
cephalosporin, fourth generation cephalosporin or carbapenem OR screening positive for
carbepenamase or extended spectrum beta lactamase (ESBL) production.
Exclusion Criteria:
- Repeated isolation of the same organism from the same patient within the study period.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Phone: 866-278-5833
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