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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR MEROPENEM

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Clinical Trials for Meropenem

Trial ID Title Status Sponsor Phase Summary
NCT00050401 Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support Completed AstraZeneca Phase 3 The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. The study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.
NCT00061438 A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died Completed AstraZeneca Phase 4 This is a research study in patients having a condition known as necrotizing pancreatitis. This is inflammation of the pancreas (an intestinal organ which assists with digestion) that has resulted in the damage and death of some pancreatic tissue. This damaged pancreatic tissue may develop a bacterial infection, which can cause further -sometimes very serious- health problems. It may be possible to prevent or delay infection by giving 'prophylactic' antibiotics (that is - to provide protection before any infection starts). However, it is not certain that this antibiotic therapy will be successful. This study is being carried out to see whether the antibiotic 'Meropenem' (which is also known as MERREM I.V.) provides protection from developing a pancreatic infection. This will be done by comparing the progress of patients who receive meropenem with those who receive a non-active placebo solution (a solution that does not contain any active medication). Meropenem or placebo would be given in addition to the standard treatment received for pancreatitis. It is not known if meropenem will help prevent infections associated with necrotizing pancreatitis. Approximately 240 patients will take part in this study. Study participation will be carried out for up to 6 weeks, and patients will receive the study treatment up to a maximum of 21 days.
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.
NCT00307099 Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU Terminated National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 This study will enroll 460 subjects who have new pulmonary infiltrates during their ICU stay and who are at low risk of having pneumonia, as determined using the Clinical Pulmonary Infection Score (CPIS). The study is designed to determine whether 3 days of antibiotic treatment with meropenem (with or without coverage for MRSA) for ICU subjects diagnosed with new pulmonary infiltrates can reduce the emergence of anti-microbial-resistant organisms and the isolation of a potential pathogen compared to a standard course of antibiotic therapy (minimum of 8 days of therapy with antibiotics of the primary care team's choosing). Subjects will be randomly placed in either the meropenem group or standard antibiotic therapy group. The study will also examine whether short-course therapy reduces hospital length of stay and hospital cost, without having a negative effect on subject morbidity and mortality.
NCT00318552 Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients. Completed AstraZeneca Phase 4 This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.
NCT00318994 Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis Completed AstraZeneca Phase 4 To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis requiring surgery between 30 to 60 minutes after a bolus of 1 g IV meropenem given during the induction period of anesthesia.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Meropenem

Condition Name

Condition Name for Meropenem
Intervention Trials
Complicated Intra-Abdominal Infection 6
Sepsis 6
Acute Pyelonephritis 5
Infection 4
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Condition MeSH

Condition MeSH for Meropenem
Intervention Trials
Infection 32
Communicable Diseases 28
Pneumonia 13
Intraabdominal Infections 12
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Clinical Trial Locations for Meropenem

Trials by Country

Trials by Country for Meropenem
Location Trials
United States 164
Spain 30
Italy 20
Hungary 12
Argentina 10
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Trials by US State

Trials by US State for Meropenem
Location Trials
Ohio 16
New York 13
California 13
Florida 11
Texas 9
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Clinical Trial Progress for Meropenem

Clinical Trial Phase

Clinical Trial Phase for Meropenem
Clinical Trial Phase Trials
Phase 4 22
Phase 3 29
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Meropenem
Clinical Trial Phase Trials
Completed 36
Recruiting 20
Not yet recruiting 13
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Clinical Trial Sponsors for Meropenem

Sponsor Name

Sponsor Name for Meropenem
Sponsor Trials
AstraZeneca 10
Merck Sharp & Dohme Corp. 5
Department of Health and Human Services 4
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Sponsor Type

Sponsor Type for Meropenem
Sponsor Trials
Other 81
Industry 45
U.S. Fed 5
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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
Medtronic
McKinsey
Queensland Health
Healthtrust
Moodys
Mallinckrodt
Julphar

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