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Antibiotic Resistance in Global Pediatric Oncology Centers

Antibiotic Resistance in Global Pediatric Oncology Centers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03721562
Enrollment
560
Registered
2018-10-26
Start date
2019-02-26
Completion date
2022-07-29
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Resistant Infection

Keywords

Antibiotic Resistance, Gram Negative Bacteria, Pediatric Patients

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.

Interventions

None listed

Sponsors

Johns Hopkins University
CollaboratorOTHER
Tarleton State University
CollaboratorUNKNOWN
St. Jude Children's Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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 carbapenemase or extended spectrum beta lactamase (ESBL) production.

Exclusion criteria

* Repeated isolation of the same organism from the same patient within the study period.

Design outcomes

Primary

MeasureTime frameDescription
Patterns of organism and resistance in participating sitesapproximately 6 months after completion of data collectionNumber of isolated organisms by anatomic site and geographic site
Genetic relatedness between bacteria at participating sitesapproximately 6 months after completion of data collectionWhole genome sequencing results will be used to describe whether isolated organisms appear to be related phylogenetically.

Countries

El Salvador, Guatemala, Panama, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026