A Comparative Study of Trovan and Ceftriaxone

Overview

• A January 2002 article in The Pediatric Infections Disease Journal discusses the results of a global clinical trial conducted in children with bacterial meningitis comparing intravenous Trovan and Ceftriaxone.

• The research shows that there was no significant difference in outcomes when patients were treated with either Trovan or Ceftriaxone.

• The article concludes that Trovan is an effective antibiotic for the treatment of pediatric bacterial meningitis.

Clinical Trial Background

• The purpose of the trial was to compare the safety and efficacy of Trovan with that of Ceftriaxone.

• The clinical trial was conducted from April 28, 1998 to July 12, 1999 in multiple sites in 11 countries in North, Central and South America, Egypt, South Africa and Hungary.

• The clinical trial received approval from the review boards of each participating institution.

• Parents or legal guardians of the children, aged three months to 12 years, provided written informed consent to participate in the clinical trial.

• All of the children who participated in the clinical trial had signs and symptoms suggesting bacterial meningitis and CSF analysis compatible with bacterial cause.


Clinical Trial Results

• The results from the trial concluded that there were no significant differences between Trovan and Ceftriaxone. Five to seven weeks after treatment, there was a clinical success rate of 78 percent for Trovan and 81 percent for Ceftriaxone; as well as a death rate of two percent for Trovan and three percent for Ceftriaxone.

• The results suggest that Trovan is therapeutically equivalent to Ceftriaxone for the management of bacterial meningitis in infants and children.

• Rates of bacterial eradication, cure, severe sequelae and death were similar for both treatment groups at the end of treatment and at follow-up assessments.

• The study was terminated earlier than planned due to concerns regarding liver toxicity associated with the use of Trovan in adults with severe infections. However, none of the evaluable children developed any significant liver abnormalities.

Conclusion

• The authors conclude that Trovan is an effective antibiotic for treatment of pediatric bacterial meningitis. The results lead the authors to support further evaluation of such therapy for children with meningitis or other serious bacterial infections.


* Source: Saez-Llorens, Xavier, et al. 2002. Quinolone treatment for pediatric bacterial meningitis: a comparative study of trovafloxacin and ceftriaxone with or without vancomycin. The Pediatric Infections Disease Journal 21(1): 14-22.