{
"info": {
"nct_id": "NCT03721562",
"official_title": "Antibiotic Resistance in Global Pediatric Oncology Centers",
"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.\nHealthy volunteers allowed\nMust have maximum age of 18 Years",
"exclusion_criteria": "* Repeated isolation of the same organism from the same patient within the study period.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* 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.",
"criterions": [
{
"exact_snippets": "Pediatric (0-18 years of age)",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "years"
},
{
"operator": "<=",
"value": 18,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "bacteria isolated from a sterile site (blood, cerebrospinal fluid, body fluid)",
"criterion": "bacteria isolation from sterile site",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "urine positive for a Gram-negative bacteria",
"criterion": "Gram-negative bacteria in urine",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "nonsusceptible to at least 1 of the following: third generation cephalosporin, fourth generation cephalosporin or carbapenem",
"criterion": "antibiotic nonsusceptibility",
"requirements": [
{
"requirement_type": "nonsusceptibility",
"expected_value": [
"third generation cephalosporin",
"fourth generation cephalosporin",
"carbapenem"
]
}
]
},
{
"exact_snippets": "screening positive for carbapenemase",
"criterion": "carbapenemase production",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "screening positive for ... extended spectrum beta lactamase (ESBL) production",
"criterion": "extended spectrum beta lactamase (ESBL) production",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have maximum age of 18 Years",
"criterions": [
{
"exact_snippets": "maximum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Repeated isolation of the same organism from the same patient within the study period.",
"criterions": [
{
"exact_snippets": "Repeated isolation of the same organism from the same patient",
"criterion": "isolation of the same organism",
"requirements": [
{
"requirement_type": "frequency",
"expected_value": "repeated"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}