Antibiotic Resistance in Global Pediatric Oncology Centers

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

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Key information

Conditions

Antibiotic Resistant Infection

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Nacional de Niños Benjamín Bloom, San Salvador, El Salvador

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Patterns of organism and resistance in participating sites

Time frame: approximately 6 months after completion of data collection

Number of isolated organisms by anatomic site and geographic site
Patterns of organism and resistance in participating sites

Time frame: approximately 6 months after completion of data collection

Number of antibiotic resistance genes/mutations of interest by geographic site
Patterns of organism and resistance in participating sites

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

Johns Hopkins University
Tarleton State University

Registry information

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Oct 26, 2018
Registry last updated: Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed