EUCTR2010-022150-16-AT进行中（未招募）不适用
Determination of Moxifloxacin concentrations in interstitial space fluid of muscle and subcutis in septic patients including a pilot phase
Medizinische Universität Wien, Univ.Klinik f.klinische Pharmakologie0 个研究点开始时间: 2010年8月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Indication to Moxifloxacin therapy
- •No Moxifloxacin therapy within the last 12 hours.
- •Severe sepsis or septic shock as diagnosed according to the criteria of ACCP/SCCM and the MAXSEP Study within 24 hours:
- •a) Severe sepsis
- •Presence of microbiologically proven, clinically proven, or
- •suspected infection
- •Presence of Systemic Inflammatory Response Syndrome
- •(SIRS) (fulfillment of at least two of the following criteria):
- •- hypo- (=36°C) or hyperthermia (=38°C)
- •- tachycardia (=90 bpm)
- •- tachypnea (=20 breaths/min) and/or an arterial pCO2 =4.3 kPa (32 mmHg) and/or mechanical ventilation
- •- leukocytosis =12,000/µl or leukopenia = 4,000/µl and/or a left shift in the differential white blood cell count =10 percent.
- •Development of at least one organ dysfunction
- •within the last 24 hours (one of the following criteria had to be fulfilled):
- •- presence of acute encephalopathia with reduced vigilance, agitation, disorientation, delirium not explained by psychotropic medication
- •- thrombocytopenia = 100.000/µl or a drop in the thrombocyte count >30 percent within 24 hours not explained by hemorrhage
- •- arterial hypoxemia with an arterial pO2 <10 kPa (75 mmHg) when breathing room air or an oxygenation index (paO2/FiO2 = 33kPa (250 mmHg) not explained by presence of a pulmonary or cardial disease
- •- arterial hypotension with a systolic blood pressure = 90 mmHg or mean arterial blood pressure = 70 mmHg for at least one hour despite adequate fluid loading not explained by other causes of shock
- •- renal dysfunction with an urine output = 0.5 ml/kg/h for at least one hour despite adequate fluid loading and/or increase of serum creatinine more than twofold above the reference range of the local laboratory
- •- metabolic acidosis with a base deficit =5.0 mmol/l or a serum lactate =1.5fold above the reference range of the local laboratory.
- •b) Septic shock
- •Presence of infection and SIRS as defined in severe
- •Presence of arterial hypotension with a systolic blood
- •pressure =90 mmHg or a mean arterial blood pressure =70 mmHg for at least 2 hours or administration of a vasopressor (dopamine =5 µg kg-1 min-1; norepinephrine, epinephrine, phenylephrine, or vasopressin in any dosage) to maintain systolic blood pressure =90 mmHg or mean arterial blood pressure =70 mmHg despite adequate fluid loading.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Allergy against study drug.
- •Bleeding disorders which prohibit intramuscular implantation of the microdialysis probe
研究者
相似试验
进行中（未招募）
1 期
Pharmacokinetic evaluation of moxifloxacin administered intravenously and orally in healthy volunteers who have had a gastric bypass.Healthy volunteers who have had a gastric bypass at least 6 months agoEUCTR2010-018628-14-BEniversity Ghent
已完成
1 期
The penetration of moxifloxacin(BAY 12-8039) into the excretory pancreatic secret after intravenous applicatiopancreatic necrosis, pre-existent obstructiv cholestasisK85C25K86.1C24.0Malignant neoplasm of pancreasOther chronic pancreatitisExtrahepatic bile ductAcute pancreatitisDRKS00000098IVERSITAETSKLINIKUM FREIBURG Allgem.- und Viszeralchirurgie20
已完成
不适用
Quantitative Determination of Nadifloxacin in Follicles of Acne Patients Treated by Topical Nadifloxacin With or Without Adapalene and Benzoyl PeroxideAcneJPRN-UMIN000025358Toshitatsu Nogita30
进行中（未招募）
不适用
Pharmacokinetics and safety of moxifloxacin; a dose escalation in patients with tuberculosis - Pharmacokinetics and safety of moxifloxaciMedDRA version: 12.1Level: LLTClassification code 10044755Term: TuberculosisTuberculosisEUCTR2010-023491-25-NLniversity Medical Center Groningen
已完成
4 期
Pharmacokinetics and safety of moxifloxacin; a dose escalation in patients with tuberculosis10028440tuberculosisNL-OMON36271niversitair Medisch Centrum Groningen20