Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support
NCT00050401
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- Onset or exacerbation of pneumonia at least 72 hours after admission to an acute care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility
- Diagnosis of hospital-acquired pneumonia requiring mechanical ventilatory support
- Patient or Patient's legal guardian must sign written informed consent for study participation, pretreatment, and Day 7 bronchoscopy
- Patients with hospital-acquired pneumonia caused by pathogens resistant to MERREM
- Patients with allergies to cephalosporins, penicillins and carbapenems
- Patients taking anticonvulsant therapy for a known seizure disorder
- Patients with lung cancer
- Patients with cystic fibrosis, acquired immune deficiency syndrome (AIDS),
neutropenia, active tuberculosis, or patients taking immunosuppressive therapy in
preparation for or following an organ transplant.
- Patients who are pregnant or breast feeding
- Patients who are unlikely to survive
- Patients with certain infections in another area requiring treatment with additional
antibiotics
- Patients with other underlying conditions that would make it difficult to interpret
response to study drug.
- Patients who have been part of another clinical study 30 days before entry into this
study.
- Patients with hypotension (systolic BP < 85mmHg) or acidosis (arterial pH <7.25 or
serum bicarbonate <15 mg/dl) despite attempts at fluid resuscitation
- Patients with profound hypoxia
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support | ||
| Official Title ICMJE | Impact of Aggressive Empiric Antibiotic Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Ventilator-associated Pneumonia | ||
| Brief Summary | 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. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 3 | ||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||
| Condition ICMJE | Pneumonia | ||
| Intervention ICMJE |
| ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | 500 | ||
| Original Enrollment ICMJE | Same as current | ||
| Actual Study Completion Date ICMJE | September 2004 | ||
| Actual Primary Completion Date | September 2004 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00050401 | ||
| Other Study ID Numbers ICMJE | 3591IL/0082 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Pfizer | ||
| Verification Date | August 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||