NCT03721562

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. 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. 2.Utilize strain typing by whole genome sequencing to describe relatedness between organisms at participating sites

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 26, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

3.4 years

First QC Date

October 22, 2018

Last Update Submit

August 2, 2022

Conditions

Antibiotic Resistant Infection

Keywords

Antibiotic ResistanceGram Negative BacteriaPediatric Patients

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Hospital Nacional de Niños Benjamín Bloom

San Salvador, El Salvador

Location

Unidad Nacional de Oncología Pediátrica

Guatemala City, Guatemala

Location

Hospital del Niño

Panama City, Panama

Location

Related Links

Study Officials

  • Sheena Mukkada, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 26, 2018

Study Start

February 26, 2019

Primary Completion

July 29, 2022

Study Completion

July 29, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations

US(2)PA(1)GU(1)EL(1)