Iclaprim is new drug to control skin infections
PROF DRRAM,HIV /AIDS,HEPATITIS ,SEX DISEASES & WEAKNESS expert,New Delhi,India, profdrram@gmail.com,+917838059592,+919832025033,ON WHATSAPP
Iclaprim is a novel diaminopyrimidine antibiotic that may be an effective and safe treatment for serious skin infections. The safety and effectiveness of iclaprim were assessed in a global phase 3, double-blind, randomized, active-controlled trial.
Six hundred thirteen adults with acute bacterial skin and skin structure infections (ABCESS) spected or confirmed to be due to Gram-positive pathogens were randomized to iclaprim (80 mg) or vancomycin (15 mg/kg of body weight), both of which were administered intravenously every 12 h for 5 to 14 days. The primary endpoint was a ≥20% reduction in lesion size compared with that at the baseline at 48 to 72 h after the start of administration of study drug in the intent-to-treat population.
Among patients randomized to iclaprim, 78.3% (231 of 295) met this primary endpoint, whereas 76.7% (234 of 305) of those receiving vancomycin met this primary endpoint (difference, 1.58%; 95% confidence interval, −5.10% to 8.26%). This met the prespecified 10% noninferiority margin. Iclaprim was well tolerated, with most adverse events being categorized as mild.
In conclusion, iclaprim was noninferior to vancomycin in this phase 3 clinical trial for the treatment of acute bacterial skin and skin structure infections. On the basis of these results, iclaprim may be an efficacious and safe treatment for skin infections suspected or confirmed to be due to Gram-positive pathogens.
Iclaprim belongs to the class of selective dihydrofolate reductase (DHFR) inhibitors, whose safety and efficacy has been clinically proven for over 4 decades . Trimethoprim (TMP) is a well-established member of this class and has been successfully employed both as a monotherapy and in combination with other agents (such as sulfamethoxazole) . However, despite the good overall safety and efficacy profile of TMP, it is only weakly bactericidal, and resistance has emerged due to the presence of specific mutations in bacterial DHFR
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