Basilea Announces Positive Top-line Data from Phase III Study of Ceftobiprole in Hospital-Acquired Pneumonia
The study compared clinical outcomes following the treatment with either ceftobiprole monotherapy or combination therapy of ceftazidime plus linezolid in patients with HAP including a subgroup of patients with microbiologically and clinically more complex ventilator-associated pneumonia (VAP). This trial is the consolidated protocol from two former HAP trials.
Overall, 69% of the clinically evaluable (CE) patients were cured with ceftobiprole compared to 72% of patients treated with combination therapy. The study met the non-inferiority criteria in both CE and intent-to-treat populations. In the CE patient population excluding VAP clinical cure rates were 77% for ceftobiprole and 76% for combination therapy.
Cure rates in the smaller VAP patient subset (about 25% of patients enrolled) were lower for ceftobiprole treated patients and non-inferiority could not be established. Further analyses are ongoing.
Ceftobiprole was generally well tolerated. The rate of overall adverse events was comparable between the two treatment groups. The adverse event profile of ceftobiprole was consistent with previous phase III studies and that of the cephalosporin class.
Ceftobiprole is currently under review by regulatory authorities in the U.S., Europe and Canada for the treatment of complicated skin and skin structure infections.
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