EUCTR2013-005583-25-ES进行中（未招募）不适用
Multicenter, randomized, open label, controlled clinical trial that compares the efficacy of the combination of colistin and meropenem versus monotherapy for the treatment of bacteremia and pneumonia due to Pseudomonas aeruginosa extremely resistant with reduced sensitivity to meropenem
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Both gender, aged 18 years old patients at time of the screening visit.
- •2. Patients with bacteremia and /or pneumonia due to extremely resistant P. aeruginosa with reduced sensitivity to meropenem and colistin susceptible that require treatment with colistine at physician criterion. In the case of bacteremia it would be enough with one positive blood culture for that type of P. aeruginosa. Pneumonia is defined with the following diagnostic criteria:
- •2.1 Acute onset of at least 3 of the following signs and symptoms (new or worsening)
- •b . Purulent sputum.
- •c . Dyspnea.
- •d . Chest pain due to pneumonia.
- •2.2 At least 1 of the following:
- •a. Fever: defined as an axillary temperature superior or equal than 38 ° C
- •b . Hypothermia is defined as an axillary temperature minor than 35 ° C
- •c . Rales on lung auscultation and/or evidence of pulmonary consolidation (dullness to percussion , bronchial breath sounds or egophony) .
- •2.3 Presence of parenchymal infiltrates lobar, multilobar or compatible with an acute bacterial pneumonia in a lung study (example: chest radiography preferably posteroanterior and lateral, one plane is acceptable if it is conclusive; or computed tomography of chest) in the 48 hours prior to first dose of study drug. The researcher can interpret the imaging study to decide whether the patient is suitable for inclusion.
- •Patients with ventilator-associated pneumonia may also be included.
- •3. Significant culture of respiratory samples will be considered as the presence of extremely resistant P. aeruginosa sputum culture of good quality (grade V: more than 25 polymorphonuclear leukocytes per field, and less than 10 epithelial cells or grade IV: over 25 polymorphonuclear leukocytes per field and 10-25 epithelial cells per field), or bronchial aspirate with more than 104 CFU/mL, or bronchoalveolar lavage with more than 103 CFU/mL or telescoping catheter culture with more than 103 CFU / mL. The presence of positive blood cultures for P. aeruginosa extremelyresistant in a patient with pneumonia it will be attributable to pneumonia in absence of other apparent source although cultures of respiratory samples are negative.
- •4. Patients able to understand study implications and demonstrate thus signing the informed consent voluntarily. The unconscious patients may participate in the trial whenever a family member or legal representative sign the informed consent designed for this purpose.
- •5. Patients of childbearing potential must have a negative pregnancy test.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •1. Allergy to penicillin or colistin, or hypersensitivity to the active principle or any of drug study.
- •2. Epilepsy.
- •3.Pregnant or breast feeding.
- •4. Participation in any other clinical trial at 3 months prior to administration of the drug.
- •5. Colonization without infection.
- •6. Any other concomitant infection.
- •7. Polymicrobial bacteremia.
- •8. Las neumonías In: simultaneous cultivate for more germs.
- •9.In neumony: other not infectious Causes of pulmonary infiltration (heart failure, pulmonary thromboembolism, active pulmonary cancer).
- •9. Patient in terminal situation.
- •10. Renal failure that requieres substitutive treatment.
- •11. Antimicrobial active treatment active during more than 72 hours.
- •12. Women in fertile age and sexually active not able to use anticonceptive methods.
- •13. Any concomitant conditions that, in opinion of the investigator, could interfere at the study conduction.
研究者
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