Infection

*The timeline requirements for this form are as follows:
Assessment Time Frame: Infections will be collected on Infection form from initiation of conditioning through the D365 timepoint. Infections collected before conditioning are reported on Pre- Conditioning Infection Assessment CRF.
Submission Time Frame: Within 5 days of collection. If infection meets SAE criteria, report SAE within 24 hours from site awareness.

This form is a Common Form and can be found in the Common Forms section. This form comes due when “Date study ICF signed” is entered on Informed Consent form AND “Is the subject eligible based on Inclusion and Exclusion criteria?” = Yes on Enrollment and Randomization form AND “Is the donor eligible based on Inclusion and Exclusion criteria?” = Yes on Donor Inclusion / Exclusion form.

Click +New section for each new or continuing infection grade 2 or above in this reporting period. The maximum number of new events which can be added is 100.

!If the infection meets SERIOUS Adverse Event criteria, please report additional information on the Adverse Event form. Infections should not be recorded as an AE unless the event results in a serious outcome. All AEs, including infection, which meet seriousness criteria will be reported as SAEs, in addition to any endpoint reporting requirements.

Refer to Appendix D – BMT CTN Infection Grading for more details.

All BMT CTN Grade II and higher infections will be reported according to BMT CTN criteria (Appendix D).

CMV and EBV reactivation is defined as the presence of CMV or EBV in blood according to World Health Organization (WHO) International Standard (> 150 copies/mL) in patients who were DNA-negative prior to HCT.

Symptomatic BK hemorrhagic cystitis will be defined using the following triad of diagnostic criteria according to European Conference on Infections in Leukemia (ECIL) guidelines:

1. Clinical symptoms/signs of cystitis, such as dysuria and lower abdominal pain
2. Hematuria grade II or higher
3. BK polyomavirus viruria of greater than 7 log10 copies/mL

Infections

Pathogen:
Indicate the pathogen type related to the observed infection by selecting one of the following options:
• Bacterial
• Fungal
• Viral
• Parasitic
• Other pathogen type, specify

Specify other pathogen type:
This field will only appear in the EDC if “Pathogen” is answered Other pathogen type, specify. Report the pathogen type in this free textbox (up to 200 characters).

Other Pathogen, Specify Organism:
This field will only appear in the EDC if “Pathogen” is answered Other pathogen type, specify. Report the pathogen’s organism in this free textbox (up to 200 characters).

Organism:
This field will only appear in the EDC if “Pathogen” is answered Bacterial, Fungal, Viral, or Parasitic. Select the organism from the pathogen-specific list.

If one of the following are selected, complete the “Other, Specify” free textbox which populates below this field (up to 200 characters).
• Other bacterial infection
• Other fungal infection
• Other viral infection
• Other parasitic infection

Infection Site (1, 2, 3, 4, 5):
Select the site(s) of infection from the options below. Each site must be indicated in its own field (with a maximum of 5 sites reported). If infection is only present in one site, leave Infection Site 2-5 fields blank.
• Blood
• Bone
• Central Nervous System (CNS)
• Eyes
• Genital Area
• GI tract, Lower
• GI tract, Upper
• Joints
• Liver/Spleen
• Lung
• Sinus and/or upper respiratory tract
• Skin, cellulitis
• Skin, necrotizing fasciitis
• Urinary tract, Lower
• Urinary tract, Upper

Date of Diagnosis:
Report the date of diagnosis (clinically, or by testing) in DD/MMM/YYYY format.

Date of Resolution:
Report the date of resolution in DD/MMM/YYYY format. If infection has not resolved, leave blank. Field will disappear if Infection ongoing is checked.

Infection ongoing:
If infection is ongoing at time of reporting, check box. If/when infection has resolved, this field should be updated (uncheck box) and a Date of Resolution entered in preceding field.

Maximum BMT CTN severity grade:
Report the maximum severity grade as Grade 2 or Grade 3, per protocol Appendix D – BMT CTN Infection Grading Criteria.

Date maximum grade achieved:
Report the date in which the maximum severity grade was first observed (clinically, or by testing) in DD/MMM/YYYY format.

Was treatment administered for this infection:
Report if treatment was administered for this infection. If treatment was administered for this infection, report all treatments on the Concomitant Medications form and link to this page

If a medication is given for treatment of an infection, the appropriate Concomitant Medications form can be linked directly to the Infection form.

To add a link to a Concomitant Medications form, you must first have entered the Concomitant Medications form to report the medication. Next, on the Infection form click +Add Link under the Concomitant Medications heading. In the pop-up window, select the Concomitant Medication to link by clicking on the checkbox to the left of the Reference # then click Save.

How was infection diagnosed?

Select at least one of the following methods of diagnoses from the options below (check all that apply).

• Clinical
• Radiographic
• Microbiologic
• Molecular diagnostic test (if selected, please select one of the following)
  • PCR
  • Antigen testing
  • Next generation sequencing testing
  • Film array
  • Other molecular test, specify
    • Specify other molecular test [This field will only appear in the EDC if “Other molecular test, specify” is selected. Report the test in this free textbox (up to 200 characters).]
• Other diagnostic test, specify
  • Specify other diagnostic test [This field will only appear in the EDC if “Other diagnostic test, specify” is selected. Report the test in this free textbox (up to 200 characters).]

Method of confirming infection resolution (check all that apply)

This section will appear if “Date of resolution” is entered.

Select at least one of the following methods used to confirm infection resolution from the options below.

• Clinical
• Radiographic
• Microbiologic
• Molecular diagnostic test (if selected, please select one of the following)
  • PCR
  • Antigen testing
  • Next generation sequencing test
  • Film array
  • Other molecular test, specify
    • Specify other molecular test [This field will only appear in the EDC if “Other molecular test, specify” is selected. Report the test in this free textbox (up to 200 characters).]
• Other diagnostic test, specify
  • Specify other diagnostic test [This field will only appear in the EDC if “Other molecular test, specify” is selected. Report the test in this free textbox (up to 200 characters).]

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