Aminoglycoside once-a-day: the philosophy of one of the first PK / TD clinical trials (1985 ...)

• netimicin (study #1)

• amikacin (study #2)

• 2 x 40 young patients

• women suffering from PID

• conventional daily doses  (N: 6mg/kg; A: 15 mg/kg)

• conventional treatment duration  (7 days)

• combine with ampicillin and  tinidazole

• randomized

• blinded to evaluators

• phospholipiduria

• high tone audiometry

• choose an adapted drug  (least toxic)

• patients with low risk

• who need treatment

• do not depart from clinical  standards if not part of the  hypothesis to test

• test your hypothesis as  correctly as possible

• use surrogate toxicity markers if avalaible and relevant

• “primum non nocere”

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