Requirements to Work Sample Clauses

Requirements to Work. Up Potential Infectious and/or Inflammatory States Prior to KTE-X19 Infusion In the absence of an identified source of infection (eg, line infection, pneumonia on chest x-ray), the minimum workup to be performed prior to administration of conditioning chemotherapy and/or KTE-X19 consists of:  Call Kite medical monitor  Infectious disease service consult (if applicable)  CT imaging of the chest, abdomen, and pelvis with IV contrast. If there is a medical contraindication to contrast, then non-contrast CT is allowed.  The following must be performed (prior to the initiation of anti-microbials if clinically feasible):  Blood cultures (aerobic and anaerobic x2 bottles each) and UA and urine culture. Deep/induced sputum culture if clinically indicated.  All indwelling lines, such as central venous catheters, should be examined for any signs of infection, and additional cultures should be drawn from the line.  Nasopharyngeal-throat (NPT) swab or equivalent assay for viral infection such as influenza A/B (including H1N1), parainfluenza 1/2/3, adenovirus, respiratory syncytial virus, coronavirus, metapneumovirus  Collection of fungal cultures and markers as appropriate (eg, galactomannan, fungitell)  Collection of appropriate serum viral studies (eg, cytomegalovirus [CMV])  If a central nervous system process is suspected, appropriate brain imaging and subsequent lumbar puncture with cytology, culture, Gram stain, and viral PCR should be performed.  Any additional sign or symptom-directed investigation should be performed as clinically indicated. Prior to proceeding with conditioning chemotherapy and/or KTE-X19 infusion, the above workup must not suggest the presence of an active infection, and all requirements for conditioning chemotherapy and/or KTE-X19 infusion must be satisfied. If the KTE-X19 infusion is delayed > 2 weeks following conditioning chemotherapy, protocol guidelines should be followed regarding the need for repeat conditioning chemotherapy.  If the above workup was triggered due to CRP > 100 mg/L, CRP should be repeated, and if CRP continues to increase significantly, evaluation should be performed for any other potential infectious or inflammatory condition not previously evaluated. KTE-C19 Kite Pharma, Inc. Xxxxxxxx XXX-X00-000 Amendment 6  Adverse/Serious Adverse Event reporting (refer to Section 9 )  Concomitant medications documentation (see Section 6.7) Following the initial hospitalization for the KTE-X19 infusion, if the subj...