Antibiotic Resistance in Global Pediatric Oncology Centers
- Conditions
- Antibiotic Resistant Infection
- Registration Number
- NCT03721562
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 560
- 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 carbapenemase or extended spectrum beta lactamase (ESBL) production.
- Repeated isolation of the same organism from the same patient within the study period.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patterns of organism and resistance in participating sites approximately 6 months after completion of data collection Correlation of known mutations/genes of interest with drug resistance phenotype
Genetic relatedness between bacteria at participating sites approximately 6 months after completion of data collection Whole genome sequencing results will be used to describe whether isolated organisms appear to be related phylogenetically.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Hospital Nacional de Niños Benjamín Bloom
🇸🇻San Salvador, El Salvador
Unidad Nacional de Oncología Pediátrica
🇬🇹Guatemala, Guatemala
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Hospital del Niño
🇵🇦Panamá, Panama