{
    "info": {
        "nct_id": "NCT03397914",
        "official_title": "Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections",
        "inclusion_criteria": "1. Age between one year and 18 years\n2. All paediatric cancer patients who are prescribed intravenous colistin due to:\n\n   * Sepsis due to MDR or minimally susceptible gram-negative bacteria\n   * History of MDR gram-negative infection or sepsis due to organisms sensitive to colistin.\n   * Culture result consistent with MDR gram negative for this febrile neutropenic episode.\n   * Patient in sepsis and colistin was administered empirically to increase antibiotic coverage.\nHealthy volunteers allowed\nMust have minimum age of 1 Year\nMust have maximum age of 18 Years",
        "exclusion_criteria": "1. Age less than one year or over 18 years\n2. Patients with renal impairment\n3. Colistin use less than 72 hours",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age between one year and 18 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age between one year and 18 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1
                            },
                            {
                                "operator": "<=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "2. All paediatric cancer patients who are prescribed intravenous colistin due to:",
            "criterions": [
                {
                    "exact_snippets": [
                        "paediatric cancer patients"
                    ],
                    "criterion": "cancer",
                    "requirement_type": "patient type",
                    "expected_value": "paediatric"
                },
                {
                    "exact_snippets": [
                        "prescribed intravenous colistin"
                    ],
                    "criterion": "intravenous colistin",
                    "requirement_type": "prescription",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Sepsis due to MDR or minimally susceptible gram-negative bacteria",
            "criterions": [
                {
                    "exact_snippets": [
                        "Sepsis"
                    ],
                    "criterion": "sepsis",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "MDR or minimally susceptible gram-negative bacteria"
                    ],
                    "criterion": "gram-negative bacteria",
                    "requirement_type": "resistance",
                    "expected_value": [
                        "MDR",
                        "minimally susceptible"
                    ]
                }
            ]
        },
        {
            "line": "* History of MDR gram-negative infection or sepsis due to organisms sensitive to colistin.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of MDR gram-negative infection"
                    ],
                    "criterion": "MDR gram-negative infection",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "sepsis due to organisms sensitive to colistin"
                    ],
                    "criterion": "sepsis",
                    "requirement_type": "organism sensitivity",
                    "expected_value": "colistin"
                }
            ]
        },
        {
            "line": "* Culture result consistent with MDR gram negative for this febrile neutropenic episode.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Culture result consistent with MDR gram negative"
                    ],
                    "criterion": "MDR gram negative",
                    "requirement_type": "consistency",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "febrile neutropenic episode"
                    ],
                    "criterion": "febrile neutropenic episode",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patient in sepsis and colistin was administered empirically to increase antibiotic coverage.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patient in sepsis"
                    ],
                    "criterion": "sepsis",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "colistin was administered empirically"
                    ],
                    "criterion": "colistin administration",
                    "requirement_type": "action",
                    "expected_value": "empirical"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 1 Year",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 1 Year"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 1
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Age less than one year or over 18 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age less than one year"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 1
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "over 18 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "2. Patients with renal impairment",
            "criterions": [
                {
                    "exact_snippets": [
                        "renal impairment"
                    ],
                    "criterion": "renal function",
                    "requirement_type": "impairment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "3. Colistin use less than 72 hours",
            "criterions": [
                {
                    "exact_snippets": [
                        "Colistin use less than 72 hours"
                    ],
                    "criterion": "Colistin use",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 72
                            }
                        ]
                    }
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}