Antibiotic Resistance in Global Pediatric Oncology Centers

Status Completed

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Antibiotic Resistant Infection

Clinical Trial Details

NCT number	NCT03721562
Study type	Observational
Source	St. Jude Children's Research Hospital
Contact
Status	Completed
Phase
Start date	February 26, 2019
Completion date	July 29, 2022

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03309358` - A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis	Phase 1
Recruiting	`NCT02922998` - CD64 and Antibiotics in Human Sepsis	N/A
Completed	`NCT04212403` - Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)	N/A
Recruiting	`NCT05502380` - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery	Phase 3
Withdrawn	`NCT04462133` - Optimal Tailored Treatment for H. Pylori Infection	N/A
Completed	`NCT03535324` - Opportunities for Antibiotic Optimisation and Outcomes Improvement in Patients With Negative Blood Culture (NO-BACT)	N/A
Recruiting	`NCT05950984` - Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)
Withdrawn	`NCT04230746` - Effect of Antibiotics on Urinary Microbiome	Early Phase 1
Active, not recruiting	`NCT03865706` - Inulin for Infections in the Intensive Care Unit	Phase 2
Not yet recruiting	`NCT06028217` - Chinese Hospital Acquired Pneumonia Collaboration Network: Epidemiology, Diagnosis and Treatment
Completed	`NCT05391035` - The Antibiotic Guardian Study- Clinical Evaluation of a Novel, Rapid Diagnostic for Gonorrhoea and Mycoplasma Infections.
Recruiting	`NCT05224401` - Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs	Phase 3
Not yet recruiting	`NCT03855709` - Antibiotic-resistant Bacterial Infection of Hepatic Patients
Terminated	`NCT03535272` - Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea	Phase 3
Recruiting	`NCT05902299` - Evaluation of the Impact of the Modification of Antibiotic Susceptibility Testing on Antibiotic Prescriptions
Recruiting	`NCT05293483` - The Impact of Covid-19 Hospital Care on the Prevalence of MDRO in Indonesia
Recruiting	`NCT05561504` - Helicobacter Pylori Local Prevalence and Antibiotic Resistance
Recruiting	`NCT03606031` - Digestive Microbiota Transplant
Completed	`NCT01573195` - Merck IISP Stewardship Grant for Antibiotic Best Practices	Phase 4
Not yet recruiting	`NCT03857295` - Infections Following NeuroSurgery (INS)

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.