PER-006-06已完成未知
STUDY OF PROOF OF MULTICENTER CONCEPT, IN PARALLEL GROUPS, WITH ACTIVE CONTROL, OPEN-LABELED, RANDOMIZED, PROSPECTIVE, PHASE II, IN ADULT PATIENTS WITH SKIN INFECTIONS AND COMPLICATED CUTANEOUS STRUCTURES REQUIRING HOSPITALIZATIO
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
- 年龄范围
- 0 至 0（—）
入选标准
- •1. The informed consent has been signed by the patient or has been signed by a legal representative recognized by the local authority.
- •2. Male or female patients> 18 years of age with skin infection or cutaneous structures requiring hospitalization.
- •3. If the patient is sexually active and is a woman of childbearing age, or is a man who has a female partner of childbearing age, the patient agrees to use two contraceptive methods during the study period, of which at least one is a barrier method
- •4. If the infection is located in an area adjacent to the bone, or if septic thrombophlebitis is suspected, an appropriate imaging study of the area should indicate the absence of evidence of osteomyelitis / thrombophlebitis within 24 hours after randomization. .
- •5. A suitable sample must be obtained for the cultivation and antibiogram.
- •6. Patients should have a clinical diagnosis of a skin infection and skin structures caused by a bacterium with known or suspected susceptibility to the study treatments.
- •7. The material of the place where the infection is located is clinically
- •purulent or seropurulent.
- •8. The patient has received <24 hours of antibacterial treatment before entering the study or the patient has received <3 days of previous antibiotic treatment and has clinical evidence of treatment failure.
- •9. Has had an oral temperature> 37.5 ° C or a tympanic temperature> 37.9 ° C or a rectal temperature> 38.3 ° C during the previous 24 hours.
- •10. Presents at least two of the items listed below: a) white blood cell count> 10,000 mm or> 10% band neutrophil; b) local erythema; c) local swelling; d) pain on palpation; e) fluctuation; f) regional lymphangitis.
排除标准
- •1. The patient has presented sustained shock.
- •2. The patient is likely to be discharged in less than 3 days.
- •3. Requires hemodialysis, peritoneal dialysis, plasmapheresis or hemoperfusion.
- •4. Presents osteomyelitis known or suspected in the area adjacent to the site affected by the infection of skin / skin structures.
- •5. Has septic thrombophlebitis known or suspected.
- •6. Has a known or suspected fungal, mycobacterial, viral or parasitic infection.
- •7. It has a burn of total thickness infected of any dimension or a burn that covers> 30% of the body surface.
- •8. The patient is using or is likely to use topical antibiotics.
- •9. The patient has received a drug in the research phase within the month prior to entering the study.
- •10. Have a known or suspected concomitant bacterial infection that requires treatment with antibiotics.
- •11. You have a skin infection or a chronic non-healing ulcer lasting> 2 weeks.
- •12. Patient in whom surgery constitutes the primary treatment.
- •13. Requires chronic immunosuppressive therapy or is expected to require immunosuppressive therapy> 1 month after the baseline visit.
- •14. Presents any form of epilepsy or a history of seizures.
- •15. Presents hypersensitivity to B-lactam antibiotics.
- •16. Has a history of a significant reaction to vancomycin.
- •17. Has a history of significant hypersensitivity reactions to antibiotic treatment against initial Gram-negative pathogens.
- •18. Has a history of stroke, transient ischemia, brain metastasis, expansive CNS lesion or systemic cancer in the last year and / or is receiving complementary chemotherapy.
- •19. Clearance of creatinine <80 ml / min.
- •20. Significant proteinuria.
- •21. Evidence of hepatic dysfunction.
- •22. Neutropenia or platelet count <50,000 / mm3.
- •23. History of hemolytic anemia.
- •24. It is unlikely that it complies with the administration regime, the
- •scheduled assessments or to complete the study for any other reason.
- •25. Patient has artificial heart valves, artificial joints or vascular prostheses.
- •26. Patients who are being treated or who are likely to be treated with coumarin or probenecid during the study.
- •27. You have known HIV infection or AIDS with a CD4 count <250 cells / mm3 or that you are receiving antiretroviral treatment or that you should start antiretroviral treatments.
- •28. You are pregnant or breastfeeding.
- •29. Has a concomitant illness that could make it impossible to evaluate the response or due to which it is unlikely that they can complete a treatment cycle and follow-up evaluations.
- •30. Has been previously randomized to this study or is a member of the auxiliary personnel involved in this study.
研究者
相似试验
已完成
不适用
A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia-J189 Pneumonia, unspecifiedPneumonia, unspecifiedJ189PER-004-05F. HOFFMANN-LA ROCHE LTD.,
进行中（未招募）
1 期
A clinical study to evaluate if changes in a type of scan, 18-FDG-PET-scan, can predict the evolution of the tumour when receiving a therapy with lanreotide autogel and sunitinib for a pancreatic endocrine tumourEUCTR2012-003936-21-BEHôpital de Jolimont
招募中
不适用
TR study of "A multi-center proof-of-concept phase2 study of encorafenib + binimetinib + cetuximab in patients with BRAF non-V600E mutated metastatic colorectal cancer (BIGBANG study)"Colorectal cancerJPRN-UMIN000031860ational Cancer Center Hospital East36
已完成
1 期
Proof of concept trial alternating lorlatinib with crizotinib in patients with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancerALK-rearranged advanced non-small cell lung cancerCancer - Lung - Non small cellACTRN12619000844145Royal North Shore Hospsital15
已完成
不适用
Eficacia de TAK-559 en el tratamiento de sujetos con diabetes mellitus tipo 2.-E149 Unspecified diabetes mellitus, without complicationsUnspecified diabetes mellitus, without complicationsE149PER-087-03TAKEDA PHARMACEUTICALS,