Nosocomial Pneumonia Clinical Trial
Official title:
A Multicenter, Randomized, Open Label Study to Compare the Safety and Efficacy of Levofloxacin With That of Imipenem/Cilastatin in the Treatment of Nosocomial Pneumonia
The purpose of this study is to compare the safety and effectiveness of levofloxacin with imipenem/cilastatin in the treatment of hospital-acquired pneumonia
Status | Completed |
Enrollment | 438 |
Est. completion date | June 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of hospital-acquired pneumonia as follows: hospitalization >= 48 but <= 72 hours, identification of a bacteria commonly found in hospital-acquired infections, absence of pneumonia on initial chest x-ray, normal white blood cell count, and diagnosis other than infection upon admission to hospital OR hospitalized >= 72 hours OR discharged from a hospital <= 48 hours after a hospitalization of >= 72 hours AND chest x-ray findings consistent with infection AND abnormal temperature (high or low) or abnormal white blood cell count - Specimen from respiratory tract is available for laboratory analysis - APACHE score <= 35 - Have received at least 72 hours of treatment with antibiotics administered intravenously (through a vein) and have failed that treatment providing the previous drugs were not levofloxacin or imipenem/cilastatin and there is evidence of failure (specimen from respiratory tract documenting original bacteria causing pneumonia is still present or presence of a new bacteria causing pneumonia acquired in the hospital, continued abnormal temperature or worsening of x-ray findings and at least 1 of the following: increased white blood cell count or decrease in breathing ability/increase in oxygen requirements) - Have received treatment with antibiotics administered intravenously (through a vein) for < 24 hours within 72 hours prior to study entry - Hospitalized for >= 72 hours and develop acute signs and symptoms of pneumonia while on antibiotic(s) for another reason, providing that the previous antibiotic(s) were not levofloxacin or imipenem/cilastatin, no antibiotics have been given for the pneumonia and the previous antibiotic(s) can be discontinued Exclusion Criteria: - Infection due to a bacteria that is know to be resistant to levofloxacin or imipenem or certain other drugs that may be used during the study - Have received treatment with antibiotics administered intravenously for > 24 hours within 72 hours prior to study entry - Previous allergic or serious adverse reaction to any of the drugs used in this study or to a drug similar to those used in this study - Cystic fibrosis or other lung disorder or an infection not treatable with antibiotics - Significantly decreased kidney function - Pre-infection terminal illness (such as cancer) - Decreased white blood cell count |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | PriCara, Unit of Ortho-McNeil, Inc. |
West M, Boulanger BR, Fogarty C, Tennenberg A, Wiesinger B, Oross M, Wu SC, Fowler C, Morgan N, Kahn JB. Levofloxacin compared with imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia: a multicenter, prospective, rand — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microbiological response at posttherapy will be based on eradication or persistence of the pathogen(s) isolated at admission | |||
Secondary | Clinical response at posttherapy will be based on the comparison of posttherapy signs/symptoms and radiological findings reported at posttherapy compared to those reported at admission. Clinical and microbiologic response at poststudy. |
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 |
NCT01796717 -
Optimizing Dosing Regimen of Piperacillin/Tazobactam for Nosocomial Pneumonia
|
Phase 2/Phase 3 | |
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)
|
||
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 |