Prospective study for clinical effectiveness and safety of TAZ/PIPC for the prevention of infectious complication of high risk lung cancer surgery

Prospective study for clinical effectiveness and safety of TAZ/PIPC for the prevention of infectious complication of high risk lung cancer surgery - Antimicrobial prophylaxis with TAZ/PIPC for the infectious complication of high risk lung cancer surgery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003532

Enrollment

Registered

2010-04-26

Start date

2010-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant lung tumor

Interventions

TAZ/PIPC 4.5g is administered twice, 30 minute before the operation and about 3 hours later. Unless infectious complication is observed, the antimicrobial prophylaxis is performed on the operation day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who satisfy the criteria of 1), 2), 3), 4), and at least one of the 5) are eligible for this study. 1)Patient who was diagnosed as lung cancer pathologically. 2)The projected operation is more than segmentectomy. 3)Performance Status (ECOG scale): 0 or 1 4)Noutrophilic leukocyte count >1500/mm3 Platelet count > 75,000/mm3 Hemoglobin = or > 9.0g/dl AST(GOT)/ALT(GPT) = or <100 IU/L Total bilirubin = or < 2.0mg/dl PaO2 = or > 60Torr Creatinine clearance = or > 50ml/min [with Cockcroft-Gault method] or serum creatin level: within normal limits 5)According to "Health-Care Associated Pneumonia (HCAP)" criteria, *Patients who were hospitalized for more than two days for the past 90 days *Patients who were admitted to nursing homes, care/rehabilitation facilities or health/care facilities for recuperation (for more than 48 hours) *Patients who receive hemodialysis therapy for renal failure *Patients whoes family was proven to be colonized by multidrugresistant bacteria *Patients who suffer from diabetes mellitus or immunodeficiency *Patients who receive steroids or other immunosuppressant

Exclusion criteria

Exclusion criteria: 1)Patients with the medical history of hypersensitivity to penicillin 2)Patients who suffer from active infectious disease or were proven to be colonized by MRSA 3)Patients who have other malignant tumor

Design outcomes

Primary

Measure	Time frame
Rate of the post-operative infectious complications	—

Secondary

Measure	Time frame
1 Safety 2 Rate of potentially or verified drug-resistant pathogen in the sputum collected by the post-operative bronchofiberscope	—

Countries

Japan

Contacts

Public ContactTeruaki Mizobuchi

Graduate School of Medicine, Chiba University Department of General Thoracic Surgery

tmizobuchi@faculty.chiba-u.jp+81-43-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026