Treatment of severe systemic inflammatory response syndrome and sepsis with a novel bradykinin antagonist, deltibant (CP-0127). Results of a randomized, double-blind, placebo-controlled trial. CP-0127 SIRS and Sepsis Study Group

JAMA. 1997 Feb 12;277(6):482-7.


Objective: To test the effect of a novel bradykinin antagonist, deltibant (CP-0127), on survival, organ dysfunction, and other outcomes in patients with the systemic inflammatory response syndrome (SIRS) and presumed sepsis.

Design: Multicenter, randomized, placebo-controlled, double-blind, parallel, dose-ranging trial. Follow-up for 28 days or until death.

Setting: A total of 47 US referral hospitals.

Patients: A total of 504 patients with SIRS and documented evidence of infection plus either hypotension or dysfunction of 2 organ systems.

Interventions: Three-day continuous intravenous infusion of either placebo or 1 of 3 doses (0.3, 1.0, or 3.0 microg x kg(-1) x min(-1)) of deltibant. Concurrent therapy at the discretion of the treating physician.

Main outcome measure: Risk-adjusted, 28-day, log-normal intent-to-treat survival analysis. Risk adjustment was performed using a study-specific risk model derived from the APACHE III database.

Results: Deltibant had no significant effect on risk-adjusted 28-day survival. In a posthoc analysis, risk-adjusted 7-day survival showed a nonsignificant trend toward improvement (P=.09). The 28-day risk-adjusted survival in the prospectively defined subset of patients with gram-negative infections showed a statistically significant improvement (P=.005).

Conclusions: Deltibant may have some effect on survival in patients with SIRS and gram-negative sepsis; however, additional studies would be required to prove this.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Bradykinin Receptor Antagonists*
  • Double-Blind Method
  • Drug Administration Schedule
  • Gram-Negative Bacterial Infections / drug therapy
  • Gram-Negative Bacterial Infections / physiopathology
  • Humans
  • Hypotension / etiology
  • Middle Aged
  • Multiple Organ Failure / etiology
  • Peptides / administration & dosage
  • Peptides / therapeutic use*
  • Sepsis / drug therapy
  • Sepsis / physiopathology
  • Survival Analysis
  • Systemic Inflammatory Response Syndrome / drug therapy*
  • Systemic Inflammatory Response Syndrome / physiopathology


  • Bradykinin Receptor Antagonists
  • Peptides
  • deltibant