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Safety of intravenous infusion of doripenem

Rebecca Redman1, Thomas M File

  • 1Anti-Infectives Clinical Development, Johnson & Johnson Pharmaceutical Research & Development, 6500 Paseo Padre Pkwy., Fremont, CA 94555, USA. rredman@its.jnj.com

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|July 22, 2009
PubMed

Insights

Doripenem, a new carbapenem antibiotic, demonstrated favorable safety and tolerability in clinical trials for serious nosocomial infections. This new antibiotic showed a low risk of seizures, comparable to existing treatments.

Area of Science:

  • Infectious Diseases
  • Pharmacology
  • Clinical Trials

Background:

  • Carbapenems are crucial for treating severe nosocomial infections.
  • Seizures are a primary safety concern with carbapenem antibiotics.
  • Doripenem is a novel carbapenem with preclinical evidence of low neurotoxicity.

Purpose of the Study:

  • To evaluate the safety and tolerability of intravenous doripenem.
  • To compare doripenem's safety profile against active comparator drugs.
  • To assess the seizure risk associated with doripenem administration.

Main Methods:

  • Phase 2 and 6 Phase 3 clinical trials were conducted.
  • Safety data were collected from 1817 patients receiving doripenem.
  • 1325 patients received active comparator drugs.

Main Results:

  • Intravenous doripenem was found to be safe and well-tolerated.
  • Doripenem exhibited a safety profile comparable to comparator agents.
  • Doripenem demonstrated a limited propensity to induce seizures, irrespective of infusion duration.

Conclusions:

  • Intravenous doripenem is a safe and well-tolerated treatment option for nosocomial infections.
  • Doripenem offers a favorable safety profile, including a low risk of seizures.
  • Doripenem can be administered via 1-hour or 4-hour infusion without increasing seizure risk.

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