Antibiotic Resistance in Global Pediatric Oncology Centers

Antibiotic Resistant Infection Clinical Trial

Official title:

Antibiotic Resistance in Global Pediatric Oncology Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721562
• Other study ID #: ARGO
• Status: Completed
• Start date: February 26, 2019
• Est. completion date: July 29, 2022

Study information

• Verified date: August 2022
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Resistant Infection

Locations

Country	Name	City	State
El Salvador	Hospital Nacional de Niños Benjamín Bloom	San Salvador
Guatemala	Unidad Nacional de Oncología Pediátrica	Guatemala
Panama	Hospital del Niño	Panamá
United States	Texas Children's Hospital	Houston	Texas
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	Johns Hopkins University, Tarleton State University

Countries where clinical trial is conducted

United States,  El Salvador,  Guatemala,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patterns of organism and resistance in participating sites	Number of isolated organisms by anatomic site and geographic site	approximately 6 months after completion of data collection
Primary	Patterns of organism and resistance in participating sites	Number of antibiotic resistance genes/mutations of interest by geographic site	approximately 6 months after completion of data collection
Primary	Patterns of organism and resistance in participating sites	Correlation of known mutations/genes of interest with drug resistance phenotype	approximately 6 months after completion of data collection
Primary	Genetic relatedness between bacteria at participating sites	Whole genome sequencing results will be used to describe whether isolated organisms appear to be related phylogenetically.	approximately 6 months after completion of data collection

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital