title: Safety and Tolerability of Doripenem in Hospitalized Children With Complicated Intra-Abdominal Infection, Complicated Urinary Tract Infections and Pneumonia.
abstract: Three multicenter, randomized, controlled studies evaluated doripenem in children 3 months to <18 years of age, with complicated intra-abdominal or urinary tract infections and bacterial pneumonia.In the 66 patients treated with doripenem before early termination of the studies for nonsafety reasons, doripenem was safe and generally well tolerated. Low enrollment limited ability to assess benefits and risks of doripenem in children.
authors.affiliation: From the *Division of Infectious Diseases, Department of Pediatrics, University of California San Diego; †Rady Children's Hospital, San Diego, California; ‡Infectious Diseases and Vaccines, §Statistics & Decision Sciences, and ¶Clinical Pharmacology, Janssen, Pharmaceutical Companies of Johnson and Johnson, Raritan, New Jersey; ‖Department of Pediatric Surgery, Lithuanian University of Health Sciences, Kaunas, Lithuania; **Department of Pediatrics #1 and Neonatology, Kharkiv National Medical University, Kharkiv, Ukraine; and ††Department of Lung Diseases and Pediatric Rheumatology, Medical University of Lublin, Poland University Children's Hospital, Lublin, Poland.
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Cannavino
authors.forename: Bibiana
authors.initials: B
authors.lastname: Castaneda-Ruiz
authors.forename: Rebecca
authors.initials: R
authors.lastname: Redman
authors.forename: Oscar
authors.initials: O
authors.lastname: Go
authors.forename: Iolanda
authors.initials: I
authors.lastname: Cirillo
authors.forename: Vidmantas
authors.initials: V
authors.lastname: Barauskas
authors.forename: Ganna
authors.initials: G
authors.lastname: Senatorova
authors.forename: Andrzej
authors.initials: A
authors.lastname: Emeryk
authors.forename: John S
authors.initials: JS
authors.lastname: Bradley
mesh_terms: D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use; D015780:Carbapenems / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D000077726:Doripenem; D006760:Hospitalization; D006801:Humans; D007223:Infant; D059413:Intraabdominal Infections / Q000188:drug therapy*; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000188:drug therapy*
chemical_list: D000900:Anti-Bacterial Agents; D015780:Carbapenems; D000077726:Doripenem