CLINICAL TRIALS PROFILE FOR MERREM IV
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All Clinical Trials for MERREM IV
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00410527 ↗ | Effectiveness of Short-Course Versus Standard Antibiotic Therapy in ICU Patients | Completed | National Institutes of Health Clinical Center (CC) | Phase 4 | 2006-08-11 | This study will compare two treatment strategies (standard versus short-course antibiotic therapy) for preventing resistant bacterial infection in patients in the intensive care unit (ICU). ICUs are the most frequently identified source of hospital-acquired infections. This study will examine the effectiveness of 3 days of antibiotic treatment in reducing the risk of developing antimicrobial-resistant bacteria as compared with standard antibiotic therapy of at least 8 days. It will also determine whether short-course therapy can reduce the duration and costs of ICU and hospital stays, of antibiotic treatment, and of costs involving treatment of infection-related problems. Patients of participating institutions who are in the ICU may be eligible for this study. Candidates must be 18 years of age or older. They must have been in the hospital for at least 3 days, developed new pulmonary infiltrates (fluid or cells in the airspaces of the lungs) during their ICU stay and must be at low risk of having pneumonia. Participants on short-course therapy take antibiotic for 3 days; those receiving standard therapy take antibiotic for at least 8 days. Both groups receive the treatment intravenously (through a vein). Sputum specimens are collected at baseline (before starting therapy) and on days 3, 10, and 28. Throat culture specimens are obtained at baseline and on days 3, 10, and 28. Nasal and anal or stool samples are collected at baseline and on days 10 and 28. Cultures of respiratory specimens obtained throughout the study period are examined for evidence of antimicrobial-resistant bacteria or the isolation of a potential pathogen. All patients are followed for 28 days after enrollment or until discharge from the hospital. |
| 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 | 2003-02-01 | 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. |
| NCT00061438 ↗ | A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died | Completed | Pfizer | Phase 4 | 2003-02-01 | 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. |
| NCT00050401 ↗ | Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support | Completed | AstraZeneca | Phase 3 | 2002-07-01 | 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. |
| NCT00050401 ↗ | Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support | Completed | Pfizer | Phase 3 | 2002-07-01 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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