{
    "info": {
        "nct_id": "NCT03003273",
        "official_title": "Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: a Randomized Controlled Study -DALFEN Study",
        "inclusion_criteria": "* All pediatric febrile neutropenia patients treated on outpatient basis\n* Age 3 years - 18 years\n* Fulfilling low risk criteria ( Hematological malignancies in remission, No identifiable focus of infection, No Pneumonia/ mucositis / GI sepsis / Nausea-vomiting/ neurologic-mental status changes/ Central Venous Catheter (CVC) related infection, Anticipated Absolute Neutrophil Count (ANC) recovery ≤ 10 days, No organ dysfunction, Hemodynamically stable, Culture negative )\n* Afebrile for at least 24 hours, on intra-venous antibiotics\nHealthy volunteers allowed\nMust have minimum age of 3 Years\nMust have maximum age of 18 Years",
        "exclusion_criteria": "* Bone marrow involvement in solid tumor\n* Already enrolled once, in previous episode\n* On antibiotics prophylaxis\n* Retroviral positive patients\n* Patient undergone stem cell transplant",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* All pediatric febrile neutropenia patients treated on outpatient basis",
            "criterions": [
                {
                    "exact_snippets": "pediatric",
                    "criterion": "age group",
                    "requirements": [
                        {
                            "requirement_type": "category",
                            "expected_value": "pediatric"
                        }
                    ]
                },
                {
                    "exact_snippets": "febrile neutropenia",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated on outpatient basis",
                    "criterion": "treatment setting",
                    "requirements": [
                        {
                            "requirement_type": "category",
                            "expected_value": "outpatient"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 3 years - 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age 3 years - 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fulfilling low risk criteria ( Hematological malignancies in remission, No identifiable focus of infection, No Pneumonia/ mucositis / GI sepsis / Nausea-vomiting/ neurologic-mental status changes/ Central Venous Catheter (CVC) related infection, Anticipated Absolute Neutrophil Count (ANC) recovery ≤ 10 days, No organ dysfunction, Hemodynamically stable, Culture negative )",
            "criterions": [
                {
                    "exact_snippets": "Hematological malignancies in remission",
                    "criterion": "hematological malignancies",
                    "requirements": [
                        {
                            "requirement_type": "remission status",
                            "expected_value": "in remission"
                        }
                    ]
                },
                {
                    "exact_snippets": "No identifiable focus of infection",
                    "criterion": "identifiable focus of infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No Pneumonia",
                    "criterion": "pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... mucositis",
                    "criterion": "mucositis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... GI sepsis",
                    "criterion": "GI sepsis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... Nausea-vomiting",
                    "criterion": "nausea-vomiting",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... neurologic-mental status changes",
                    "criterion": "neurologic-mental status changes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... Central Venous Catheter (CVC) related infection",
                    "criterion": "Central Venous Catheter (CVC) related infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Anticipated Absolute Neutrophil Count (ANC) recovery ≤ 10 days",
                    "criterion": "Anticipated Absolute Neutrophil Count (ANC) recovery",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No organ dysfunction",
                    "criterion": "organ dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemodynamically stable",
                    "criterion": "hemodynamic stability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Culture negative",
                    "criterion": "culture",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Afebrile for at least 24 hours, on intra-venous antibiotics",
            "criterions": [
                {
                    "exact_snippets": "Afebrile for at least 24 hours",
                    "criterion": "febrile status",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 24,
                                "unit": "hours"
                            }
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "afebrile"
                        }
                    ]
                },
                {
                    "exact_snippets": "on intra-venous antibiotics",
                    "criterion": "antibiotic administration",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "intra-venous"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 3 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 3 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Bone marrow involvement in solid tumor",
            "criterions": [
                {
                    "exact_snippets": "Bone marrow involvement in solid tumor",
                    "criterion": "bone marrow involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Already enrolled once, in previous episode",
            "criterions": [
                {
                    "exact_snippets": "Already enrolled once, in previous episode",
                    "criterion": "previous enrollment",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "times"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* On antibiotics prophylaxis",
            "criterions": [
                {
                    "exact_snippets": "On antibiotics prophylaxis",
                    "criterion": "antibiotics prophylaxis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Retroviral positive patients",
            "criterions": [
                {
                    "exact_snippets": "Retroviral positive",
                    "criterion": "retroviral status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient undergone stem cell transplant",
            "criterions": [
                {
                    "exact_snippets": "Patient undergone stem cell transplant",
                    "criterion": "stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "undergone",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}