Table 1.
Patient Characteristics | N = 16 |
---|---|
Age, mean (SD), years | 33.8 (± 12.0) |
Sex, male, n (%) | 7 (44 %) |
Race, n (%) | |
White | 14 (88%) |
Black | 0 |
American Indian or Alaska Native | 0 |
Asian | 1 (6%) |
Native Hawaiian or Other Pacific Islander | 1 (6%) |
CF genotyping, n (%) | |
ΔF508 homozygous | 7 (44%) |
ΔF508 heterozygous | 7 (44%) |
Other | 2 (13%) |
BMI, mean (SD), kg/m2 | 23.2 (± 3.2) |
Comorbidities, n (%) | |
Prevalent CKD (eGFR < 90 mL/min/1.73 m2)A | 1 (6%) |
Diabetes mellitus and/or chronic insulin therapy | 7 (44%) |
Hypertension | 1 (6%) |
eGFR, mean (SD), (mL/min/1.73 m2) | 124.5 (± 31.3) |
FEV1, mean (SD), L | 1.59 (± 0.8) |
CFTR modulator use prior to enrollment, n (%) B | 1 (6%) |
Antibiotic course | |
Antibiotic course by category, n (%) | |
Aminoglycoside | 9 (56%) |
Polymyxin | 5 (31%) |
Both | 1 (6%) |
OtherC | 1 (6%) |
Days of antibiotic therapy, mean (range), days | 13.9 (12–14) |
NSAID use during study period, n (%) | 4 (25%) |
Outcomes | |
Incident CKD from end of therapy to follow-up, n (%)D,E | 7 (44%) |
Stage 2 | 3 (19%) |
Stage 3a | 1 (6%) |
Stage 3b | 1 (6%) |
Stage 4 | 2 (13%) |
Median duration to incident CKD, days (range) | 369 (104 – 751) |
Mean duration to incident CKD, days (range) | 417 (104 – 751) |
Death | 1 (6%) |
One patient met criteria for G2 CKD, a mildly decreased GFR of 60 to 89 mL/min/1.73 m2,, according to KDIGO guidelines. KDIGO. Summary of recommendation statements. Kidney Int 2013; 3 (Suppl):5.
Prior to and during study enrollment, one patient was on CFTR modulatory therapy, specifically, lumacaftor/ivacaftor.
One patient in the cohort received meropenem and aztreonam during the treatment period.
Chronic kidney disease classification based upon glomerular filtration rate (mL/min/1.73 m2), where: G1 is a normal eGFR of ≥ 90 mL/min/1.73 m2, G2 a mildly decreased eGFR of 60 to 89 mL/min/1.73 m2, G3a is a mildly to moderately decreased eGFR of 45 to 59 mL/min/1.73 m2, G3b is a moderately to severely decreased eGFR of 30 to 44 mL/min/1.73 m2, G4 is a severely decreased eGFR of 15 to 29 mL/min/1.73 m2 and G5 is kidney failure with a eGFR of <15 mL/min/1.73 m2, +/− dialysis. CKD was defined by an eGFR of less than 90 mL/min/1.73 m2 for three months or longer.
Incident or progression of CKD was determined through chart review in the years following the conclusion of the study period (i.e., 28-day period of urine and plasma collection concurrent with antibiotic therapy). Follow-up continued until patient death or lost to follow-up.