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CLINICAL TRIALS PROFILE FOR PIPERACILLIN

Clinical Trials for Piperacillin

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00003805	Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients. PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.
NCT00044746	Study Evaluating the Safety and Efficacy of Piperacillin/Tazobactam and Ampicillin/Sulbactam in Patients With Diabetic Foot Infections	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 4	Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy and Safety data in Diabetic Inpatients.
NCT00044759	Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	To compare the safety and efficacy of piperacillin/tazobactam (4 g/500 mg) administered intravenously every 6 hours to cefepime (2 g) administered intravenously every 8 hours for the empiric treatment of neutropenic fever in patients with a hematologic malignancy or lymphoma.
NCT00130754	Thymoglobuline in Non-myeloablative Allogeneic Stem-cell Transplantation	Completed	Hadassah Medical Organization	Phase 3	Allogeneic stem cell transplantation is the treatment of choice for a growing number of malignant and non-malignant indications. Until recently, myeloablative in conjunction with immunosuppressive conditioning was considered mandatory for the elimination of malignant hematopoietic cells and to prevent graft rejection. The aim of allogeneic non-myeloablative stem cell transplantation (NST) is to induce host-to-graft tolerance with fast and durable engraftment of donor stem cells, by means of conditioning, which is well-tolerated by patients. The rationale behind the NST strategy is to induce optimal graft-versus-leukemia (GVL) effects for the elimination of all malignant cells by alloreactive immunocompetent cells from a matched donor as an alternative to standard high-dose myeloablative chemo radiotherapy. The NST protocol is therefore mainly based on immunosuppression and thus contains fludarabine, low dose busulfan and anti-T-lymphocyte globulin (ATG). Thymoglobuline is a polyclonal rabbit antiserum specific for human T cells used in organ transplantation for induction of tolerance and rejection prevention and treatment. It was also used in stem-cell transplantation (SCT) for the same purposes (e.g. for generation of tolerance and rejection preclusion) as well as a treatment for graft-versus-host disease (GVHD). Data from myeloablative protocols suggest that ATG before SCT significantly reduces the risk for grade III-IV acute GVHD. This does not translate to a reduction in transplant-related mortality (TRM) because of the increased risk for infections and thus survival is unchanged. Extensive chronic GVHD was also significantly shown to be reduced in patients receiving ATG in the myeloablative setting. However, the role of ATG in the NST protocol was never evaluated in a prospective randomized trial. In view of the preliminary data suggesting of an additive effect of ATG in these circumstances we, the investigators at Hadassah Medical Organization, evaluate the effect of ATG in NST by a prospective randomized trial.
NCT00167999	Study Evaluating Piperacillin-Tazobactam on Certain Bacteria in Hematology and Oncology Units	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 4	To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in hematology and oncology units
NCT00195286	Study Evaluating Piperacillin/Tazobactam in Complicated Urinary Infections.	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 4	The primary objective is to study the efficacy of piperacillin/tazobactam in patients with complicated urinary tract infections
NCT00195533	Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients	Completed	PETHEMA (Program for the Study and Treatment of Haematological Malignances)	Phase 4	The aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for fever in neutropenic patients. Study of consecutive cohorts(2). First the patients will be included in the monotherapy branch until completing the predicted number of cases. When this happens, the Coordinating Center will communicate it to the participant centers and from then the patients will be included in the combined therapy.
Trial ID	Title	Status	Sponsor	Phase	Summary