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Antibiotic Resistance in Global Pediatric Oncology Centers

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ClinicalTrials.gov Identifier: NCT03721562
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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

Condition or disease
Antibiotic Resistant Infection

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.


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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Antibiotic Resistance in Global Pediatric Oncology Centers
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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 carbepenamase or extended spectrum beta lactamase (ESBL) production.
Criteria

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 carbepenamase or extended spectrum beta lactamase (ESBL) production.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721562


Contacts
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Contact: Sheena Mukkada, MD 866-278-5835 referralinfo@stjude.org

Locations
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United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Sheena Mukkada, MD    866-278-5833    referralinfo@stjude.org   
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: James J. Dunn, Ph.D.    832-824-2662    jjdunn@texaschildrens.org   
Principal Investigator: James J. Dunn, Ph.D.         
El Salvador
Hospital Nacional de Niños Benjamín Bloom Recruiting
El Salvador, El Salvador
Contact: Guillermo E. Barahona, MD    503-7140-1277    guille_barahona@hotmail.com   
Principal Investigator: Guillermo E. Barahona, MD         
Guatemala
Unidad Nacional de Oncología Pediátrica Recruiting
Guatemala, Guatemala
Contact: Tomás R. Letona, MD    502-3027-5187    tletona@unop.org.gt   
Principal Investigator: Tomás R. Letona, MD         
Panama
Hospital del Niño Recruiting
Panamá, Panama
Contact: Dora I. Estripeaut, MD    507-6747-5646    destripeaut@gmail.com   
Principal Investigator: Dora I. Estripeaut, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
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Principal Investigator: Sheena Mukkada, MD St. Jude Children's Research Hospital

Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT03721562     History of Changes
Other Study ID Numbers: ARGO
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:
Antibiotic Resistance
Gram Negative Bacteria
Pediatric Patients

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents