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Doripenem may be safe, effective in pediatric patients
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CHICAGO — Doripenem appears effective and well tolerated in pediatric patients, according to findings presented here during the 2011 Interscience Conference on Antimicrobial Agents and Chemotherapy.
In the first study of this parenteral carbapenem in pediatric patients, Satoshi Iwata, MD, PhD, and colleagues from six different health care facilities in Japan evaluated doripenem (Doribax, Janssen) 20 mg/kg given twice or three times. The maximum dosage was 0.5 g per dose.
One hundred children aged 2 months through 13 years (mean age 3.2 years) with a diagnosis of pneumonia, urinary tract infection, otitis media, septicemia and other infections were enrolled to this multicenter study, according to Iwata, who is professor and director of the Center for Infectious Diseases and Infection Control at the Keio University School of Medicine.
There were 58 patients with pneumonia. The primary causes of these cases were penicillin-resistant Streptococcus pneumoniae and beta-lactamase-nonproducing, ampicillin-resistant Haemophilus influenza. The clinical cure rate at the end of therapy was 92/95 (96.8%). The microbiological cure rate at end of therapy was 69/75 (92.0%).
The dosing regimen in pediatric infections was investigated from a viewpoint of pharmacokinetics (PK)/pharmacodynamics (PD) by predicting PK profiles and performing Monte-Carlo simulations.
“Results of the simulation suggested that 20 mg/kg two or three times daily gives approximately 90% or more probability of over 40% of time-above MIC attainment for S. pneumoniae and H. influenzae and maximum effect can be expected at these dose levels,” Iwata and colleagues wrote.
“We are awaiting anxiously the approval of this drug,” Iwata told Infectious Disease News
The most common study drug-related adverse event was diarrhea, which occurred in 7% of patients. No seizures were reported.
Doripenem is currently approved for use as a single agent in patients aged 18 years and older for the treatment of complicated intra-abdominal infections and complicated urinary tract infections caused by susceptible gram-negative and gram-positive organisms.
Disclosures: Dr. Iwata received a consulting fee for serving as a Shionogi & Co. Scientific Advisor.
For more information:
- Sunakawa K. #G3-176. Presented at: The 2011 ICAAC; Sept. 17-20; Chicago.
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