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

UMIN ID: UMIN000017219

Registered date:22/04/2015

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: postoperative pneumonia after esophagectomy for esophageal cancer
• Date of first enrollment: 2013/11/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intravenous administration of Biapenem 300mg every six hours for the patient of postoperative pneumonia after esophagectomy

Outcome(s)

• Primary Outcome: Days required for the treatment of Biapenem Postoperative hospital stay
• Secondary Outcome: Clinical and bacteriological efficacy rates at each time point during the use of Biapanem.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: Other 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

• Primary Sponsor: Department of Gastrointestinal Surgery, The University of Tokyo Hospital
• Source(s) of Monetary Support: Department of Gastrointestinal Surgery