Clinical Trials Logo

Clinical Trial Summary

1. To observe clinical and bacteriologic responses of different regimens of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) for treatment of nosocomial pneumonia.

2. To describe the pharmacokinetic profile of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) in patients with nosocomial pneumonia.

3. To assess the safety profiles of piperacillin/tazobactam 4.5g q6h, prolonged or intermittent infusion in patients with nosocomial pneumonia.


Clinical Trial Description

Enrolled patients will be randomized into therapeutic or controlled group. Controlled group will receive piperacillin/tazobactam of 4.5g Q6h, intermittent infusion for 30 minutes. Therapy group will receive piperacillin/tazobactam of 4.5g Q6h, prolonged infusion for 4 hours. The duration is 7-14 days.

Two sets of blood cultures (for aerobic and anaerobic culture) were obtained before the study and post-treatment period if first blood culture is positive. Cultures from the lower respiratory tract infection were obtained before (within 48 h) the study and on the last day of therapy. The lower respiratory tract specimens obtained either by endotracheal aspiration, bronchoalveolar lavage (BAL), a protected brush procedure (PBP) or as sputum were required to show > 25 polymorphonuclear cells and < 10 squamous epithelial cells per field (at 100× magnification).

The plasma concentration of piperacillin and tazobactam will be determined by LC/MS/MS method. The QC samples will also be analyzed simultaneously with each run for the method stability testing, according to the laboratory standard procedure. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01796717
Study type Interventional
Source Tianjin Medical University Cancer Institute and Hospital
Contact Wang Donghao, chief
Phone 022-23340123
Email donghaow@medmail.com.cn
Status Recruiting
Phase Phase 2/Phase 3
Start date March 2012
Completion date December 2016

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04488510 - Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia:
Completed NCT02598609 - SEPREVEN: a Stepped-wedge Randomised Controlled Trial N/A
Completed NCT01431326 - Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Completed NCT06162455 - High-dose Inhaled NO Therapy for the Prevention of Nosocomial Pneumonia After Cardiac Surgery With CPB N/A
Terminated NCT01897792 - Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma Phase 2
Completed NCT01363271 - Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients Phase 4
Recruiting NCT00842478 - Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia Phase 2/Phase 3
Completed NCT00610324 - Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients Phase 4
Completed NCT04279873 - Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia
Completed NCT03303937 - Characteristics of Lower Respiratory Tract Escherichia Coli Isolates in Mechanically Ventilated Intensive Care Patients N/A
Recruiting NCT06170372 - High-dose Inhalations of Nitric Oxide in the Treatment of Pneumonia N/A
Completed NCT00829842 - Oral Hygiene With Chlorhexidine and Incidence of Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery Phase 3
Recruiting NCT06261827 - High-dose Inhaled NO Therapy for the pREvenvention of NP After Cardiac Surgery Under CPB N/A
Completed NCT05928208 - The Role of Point-of-care Polymerase Chain Reaction in Managing Nosocomial Pneumonia
Completed NCT02793141 - International Study on NoSocomial Pneumonia in Intensive CaRE (PneumoINSPIRE)
Completed NCT00236834 - A Study of the Safety and Effectiveness of Levofloxacin Compared With Imipenem/Cilastatin in Patients With Pneumonia Acquired During Hospitalization Phase 3
Not yet recruiting NCT06310941 - Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection N/A
Completed NCT02413242 - Advanced Understanding of Staphylococcus Aureus and Pseudomonas Aeruginosa Infections in EuRopE - ICU
Recruiting NCT04223752 - Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036) Phase 1