NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000017219

Registered date:22/04/2015

Feasibility and efficacy of the de-escalation therapy by Biapenem for postoperative bacterial pneumonia.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedpostoperative pneumonia after esophagectomy for esophageal cancer
Date of first enrollment2013/11/01
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Intravenous administration of Biapenem 300mg every six hours for the patient of postoperative pneumonia after esophagectomy

Outcome(s)

Primary OutcomeDays required for the treatment of Biapenem Postoperative hospital stay
Secondary OutcomeClinical and bacteriological efficacy rates at each time point during the use of Biapanem.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum85years-old
GenderMale and Female
Include criteriaCanditates for esophagectomy in the University of Tokyo Hospital are pre-registered as candidates of this study. No exclusion criteria for the reconstruction methods. Well informed and written convent. Patients with the written informed concent are registered when diagnosed as postoperative pneumonia within 14 days after the operation along with the standard diagnostic criteria.
Exclude criteriaOther infectious disease including SSI is present. History of hyper reactive events caused by carbapenem. The suspected pathogenic microbes of the pneumonia is; MRSA, MDRP, virus, mycoplasma, regionera, clmamigia, MAC, yeast. MRSA or MDRP is present in any culture specimen during the in hospital course. History of epilepsy or barproic acid use. Renal disease with Ccr lower than 20ml/kg.min or requiring hemodialysis.

Related Information

Contact

public contact
Name Koichi Yagi
Address 7-3-1 Hongo Bunkyo ku, Tokyo, Japan Japan
Telephone 03-3815-5411
E-mail Yagik-tky@umin.ac.jp
Affiliation The University of Tokyo Hospital Department of Gastrointestinal Surgery
scientific contact
Name Koichi Yagi
Address 7-3-1 Hongo Bunkyo-ku, Tokyo, Japan Japan
Telephone 03-3815-5411
E-mail Yagik-tky@umin.ac.jp
Affiliation The University of Tokyo Hospital Department of Gastrointestinal Surgery