title: A comparison of the pharmacokinetics of Aspen Ceftriaxone and Rocephin in community-acquired meningitis.
abstract: BACKGROUND
  Community-acquired bacterial meningitis (CABM) is a life-threatening condition that is common among immunocompromised individuals. Intravenous ceftriaxone, of which Rocephin (ROC) is the originator brand, is recommended as first-line therapy in South Africa. Despite concerns regarding therapeutic equivalence with generic agents, this is the first study that has been conducted comparing clinical pharmacokinetics (PK) of a generic ceftriaxone formulation with the originator.
  
  
  OBJECTIVE
  To compare the PK and safety of Aspen Ceftriaxone (AC) and ROC in the treatment of adult CABM.Methods. A total of 63 eligible patients were randomised 1:1 to receive 2 g of either medication twice daily for a duration based on the identity of the causative organism and their physician's clinical judgment. The primary endpoint of this study was the comparison of clinical PK, specifically the concentrations of each drug in the cerebrospinal fluid with corresponding paired plasma samples. While this study was underpowered to assess efficacy, safety could be evaluated on the basis of reported adverse events.
  
  
  RESULTS
  The two patient groups were epidemiologically similar. There were no statistically significant differences in PK between either agent, nor any difference with regard to safety.
  
  
  CONCLUSIONS
  AC can be considered as equivalent to ROC with regard to PK and safety in patients with CABM.
authors.affiliation: Division of Pulmonology and Critical Care, Department of Medicine, University of the Witwatersrand and Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa. guy.richards@wits.ac.za.
authors.forename: Guy A
authors.initials: GA
authors.lastname: Richards
authors.forename: Eugene
authors.initials: E
authors.lastname: Elliott
authors.forename: Erica J
authors.initials: EJ
authors.lastname: Shaddock
authors.forename: David
authors.initials: D
authors.lastname: Mushi
authors.forename: Mogiyana
authors.initials: M
authors.lastname: Mzileni
authors.forename: Roanne
authors.initials: R
authors.lastname: Ray
authors.forename: Stephen
authors.initials: S
authors.lastname: Rulisa
authors.forename: Freddy
authors.initials: F
authors.lastname: Seolwane
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Stacey
authors.forename: Anton
authors.initials: A
authors.lastname: Stoltz
authors.forename: Jacqueline P
authors.initials: JP
authors.lastname: Venturas
authors.forename: Herman
authors.initials: H
authors.lastname: Schoeman
mesh_terms: D018806:APACHE; D061605:Administration, Intravenous; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D001682:Biological Availability; D002443:Ceftriaxone / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D017714:Community-Acquired Infections / Q000134:cerebrospinal fluid / Q000188:drug therapy* / Q000382:microbiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016903:Drug Monitoring; D016568:Drugs, Generic / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D008297:Male; D016920:Meningitis, Bacterial / Q000134:cerebrospinal fluid / Q000188:drug therapy* / Q000382:microbiology; D008875:Middle Aged; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D016568:Drugs, Generic; D002443:Ceftriaxone