PER-004-05已完成未知
A STUDY OF PROOF OF MULTICENTER CONCEPT, OF PARALLEL GROUPS, CONTROLLED WITH ACTIVE COMPARATOR, DOUBLE-BLIND, RANDOMIZED, PROSPECTIVE PHASE II IN ADULT PATIENTS WITH PNEUMONIA ACQUIRED IN THE COMMUNITY THAT REQUIRES HOSPITALIZATION, WITHOUT EVIDENCE ANY OF LEGIONELLA.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients of both sexes> 18 years of age requiring hospitalization with pneumonia acquired in the community or who develop pneumonia within 48 hours after their hospitalization
- •2. Having a fever, defined as body temperature> 38.0 ° C (100.4 ° F) oral; or> 38.5 ° C (101.2 ° F) tympanic
- •3. That they present a new cough or increase of a productive preexisting cough, with purulent sputum for culture and susceptibility tests.
- •4. Having either pleuritic chest pain, dyspnea, or tachypnea
- •5. That they present auscultatory findings indicative of pneumonic consolidation or pneumopathic process compatible with the diagnosis of pneumonia
- •6. With confirmatory thoracic radiography of infiltrate or lobular consolidacton
- •7. Patients with samples of respiratory secretion and two cultures of blood.
- •8. With a negative determination of the Legionella antigen in urine (Binax® Method)
- •9. Have an APACHE II score between 9 and <24
- •10. If the patient has sexual intercourse and is a woman of childbearing age, or is a male has a female partner of childbearing age, the patient agrees to use during the period of study two contraceptive methods, of which at least one is a method of barrier.
- •11. With a high total leukocyte count in peripheral blood
- •12. That they have signed an informed consent.
排除标准
- •1. Patients with a Pneumonia Severity Index <90
- •2. That they have presented with prolonged shock
- •3. When the investigator considers that his or her background, the findings of the physical examination and the chest radiograph are highly indicative of atypical pneumonia
- •4. That require endotracheal intubation and ventilation, or that in the opinion of the investigator, may require them
- •5. When you are likely to be discharged in less than 3 days
- •6. Who presented pneumonia after more than 48 hours of hospital admission
- •7. Have been admitted to a recovery clinic or day care center within 60 days prior to randomization
- •8. That require hemodialysis, peritoneal dialysis, plasmapheresis or hemoperfusion
- •9. Having known bronchial obstruction or a history of post-obstructive pneumonia
- •10. With known or suspected lung abscess, empyema, or evidence of a pleural effusion calculated at> 500 ml
- •11. With primary lung cancer or some malignant metastatic tumor in the lungs
- •12. Show signs of meningitis
- •13. With known or suspected cystic fibrosis or with suspected active tuberculosis
- •14. With known or suspected concomitant bacterial infection requiring antibiotic treatment
- •15. That require chronic immunosuppressive therapy or that are expected to require immunosuppressive therapy> 1 month from baseline
- •16. Having neutropenia or platelet count <50,000 / mm ^
- •17. Having any form of epilepsy or a history of seizures
- •18. Have been addicted to alcohol or drugs in the last six months
- •19. Having hypersensitivity to beta-lactam antibiotics
- •20. Have received more than one dose of a 3° Generation cephalosporin or any dose of a quinolone, macrolide or ketolide within 24 hours of randomization.
- •21. Have a history of stroke, transient ischemia, brain metastasis, expansive CNS lesion or systemic cancer in the last year and / or are receiving complementary chemotherapy
- •22. Being treated or likely to be treated with coumarin or probenecid during the study
- •23. Have a creatinine clearance, using the Cockroft-Gault equation, <70 ml / min
- •24. Having significant proteinuria
- •25. That show evidence of liver dysfunction
- •26. Having a history of hemolytic anemia
- •27. Having valvular or vascular prostheses
- •28. With known HIV infection or AIDS with a CD4 count <250 cells / mm and receiving antiretroviral treatment
- •29. That it is unlikely that they will comply with the administration regime, the scheduled evaluations or that they complete the study for any other reason
- •30. That have been previously randomized in this study or that are members of the auxiliary personnel involved in this study
- •31. That they are pregnant or breastfeeding
- •32. Having a concomitant illness that could make it impossible to evaluate the response or due to which they are unlikely to complete a treatment cycle and follow-up evaluations
- •33. That they have received a drug in the research phase within 30 days prior to entering the study
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