Antimicrobial therapy is generally given to HCT recipients to help prevent infections. The following questions are intended to obtain information on the infection prophylaxis regimen received by the recipient. In general, most centers have a standard cocktail of drugs used which include an antibacterial agent (or agents), antiviral agent, antifungal agent, and an anti-pneumocystis agent. This information is often available in a transplant center SOP for infection prevention. Sometimes, recipients are on one of these medications prior to starting the preparative regimen and therefore it could be treating an infection or is being used as “secondary prophylaxis.” Information regarding primary and secondary prophylaxis can provide insight into the development of resistant infections.

Questions 208 – 210: Specify the first antibacterial drug given (select one)

Report the first antibacterial drug administered and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include antibacterial drugs started prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen.

Only one antibacterial drug may be reported. If multiple antibacterial drugs were started on the same day, report whichever drug is considered the standard prophylaxis agent at the transplant center. Centers should have an SOP defining infection prophylaxis. Seek physician clarification, as needed.

If Other antibacterial drug is selected, specify the drug. Do not include vancomycin IV or Trimethoprim/Sulfamethoxazole (Bactrim, Septra) in this data field. IV vancomycin is captured separately. Trimethoprim/Sulfamethoxazole (Bactrim, Septra) is given as PJP prophylaxis and captured below.

Report the antibacterial drug start date and ensure the date reflects the first date when the drug was administered. If the start date is prior to the start of the preparative regimen and the date is unknown, report the start date as seven days prior the start of the preparative regimen. Refer to the medical administration record to confirm the start date.

If no antibacterial drugs were given as prophylaxis, including prior to the start of the preparative regimen and no later than day +45, select None and continue with question 211. Do not report antibacterial agents given empirically for neutropenic fever.

Example 1: If both amoxicillin and levofloxacin were started as prophylaxis on the same day the preparative regimen was started, the center should report whichever agent is considered standard for prophylaxis at their institution. However, if amoxicillin was administered at the start of the preparative regimen and levofloxacin was started two days later, the center should only report amoxicillin as the first antibacterial infection prophylaxis drug.

Questions 211 – 212: Was vancomycin IV also given as prophylaxis?

Indicate Yes or No if vancomycin IV was also given for prophylaxis at the same time as the first antibacterial drug reported above. If Yes, report the start date of vancomycin IV. It is uncommon that vancomycin is used as prophylaxis, therefore, please confirm with the physician that the intent of vancomycin IV was prophylaxis.

Example 2: Amoxicillin was started as prophylaxis on the same day the preparative regimen was started, and then vancomycin IV was started on day +1 post-infusion. If the amoxicillin was continued while the recipient remained on vancomycin, select Amoxicillin in the antibacterial section and report the start date and also report Yes, vancomycin IV was also given as prophylaxis with the start date (these will have separate start dates). Vancomycin IV was given at the same time (in addition to) as the first antibacterial drug, amoxicillin. However, if amoxicillin was stopped prior to or on the same day when vancomycin was started, No would be reported.

Questions 213 – 215: Specify the first antiviral drug given (select one)

Report the first antiviral drug administered and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include antiviral drugs started prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen. If the start date is prior to the start of the preparative regimen and the start date is unknown, report the date as seven days prior the start of the preparative regimen. Only one antiviral drug may be reported.

If Other antiviral drug is selected, specify the drug. Do not include letermovir in this data field.

If no antiviral drugs were given, including prior to the start of the preparative regimen and no later than day +45, select None and continue with question 216.

Questions 216 – 217: Was letermovir (prevymis) given as prophylaxis?

Letermovir is given to prevent CMV reactivation and is generally started between Day 0 and Day +28 post-HCT.

Indicate Yes or No if letermovir was also given for prophylaxis at the same time (in addition to) as the first antiviral drug reported above. If Yes, report the start date of letermovir.

Questions 218 – 220: Specify the first antifungal drug given (select one)

Report the first antifungal drug administered and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include antifungal drugs started as prophylaxis prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen. Only one antifungal drug may be reported. If the start date is prior to the start of the preparative regimen and the start date is unknown, report the date as seven days prior to the start of the preparative regimen.

If Other antifungal drug is selected, specify the drug. Do not report Nystatin in this data field.

If no antifungal drugs were given, including prior to the start of the preparative regimen and no later than day +45, select None and continue with question 221.

Questions 221 – 223: Specify the first anti-pneumocystis (PJP) drug given (select one)

Report the first anti-pneumocystis (PJP) drug administered and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include anti-pneumocystis (PJP) drugs started prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen. Only one anti-pneumocystis (PJP) drug may be reported.

If Other anti-pneumocystis is selected, specify the drug.

If no anti-pneumocystis (PJP) drugs were given, including prior to the start of the preparative regimen and no later than day +45, select None and continue with question 224.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
Q208 – 223 5/18/2022 Add Combined Follow-Up blue instruction box added: In scenarios where a cellular therapy was given after an HCT and this form is now being completed based on the subsequent cellular therapy date, these questions do not apply and are disabled. Added for clarification
Q213 – 215 5/6/2022 Modify Updated instructions on when to report the antiviral start date as 7 days prior to prep: Report the _first antiviral drug administered and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include antiviral drugs started prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen. If the start date is prior to the start of the preparative regimen and the start date is unknown known, report the date as seven days prior the start of the preparative regimen. Only one antiviral drug may be reported._ Typo
Last modified: May 18, 2022

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