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临床试验/EUCTR2005-002634-35-DE
EUCTR2005-002634-35-DE进行中（未招募）不适用

Single centre, prospective, comparative, open-label, randomised study to evaluate the efficacy and tolerability of the combination of Moxifloxacin plus Metronidazole versus Piperacillin/Tazobactam for the treatment of patients with intra-abdominal abscesses (MEMO) - MEMO-study

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Medizinische Hochschule Hannover0 个研究点目标入组 110 人开始时间: 2005年7月6日最近更新:
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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
入组人数
110
研究概览入排标准研究者记录与标识符相似试验

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

  • •Hospitalized male or female patients more or equal 18 years of age
  • •Patients with:
  • •Documented intra-abdominal abscesses by
  • •A)Either laparotomy reveals any of the following:
  • •-Intra-abdominal abscess
  • •-Macroscopic gastrointestinal perforation
  • •B)Suspected intra-abdominal abscesses and scheduled for a laparotomy by at least three of the following criteria:
  • •-Fever (Temperature > 38.0°C rectal or oral; > 38.5°C core temperature)
  • •-Leukocytosis (WBC equal or more than 12,000 cells/mm3)
  • •-Symptoms referable to the abdominal cavity (e.g. anorexia, nausea, vomiting or pain)
  • •-Tenderness (with or without rebound), absent or diminished bowel sounds or abdominal wall rigidity
  • •-Radiological evidence (Abdominal Plain Films, CT, MRI or Ultrasound) of gastrointestinal perforation or localized collections of potentially infected material
  • •Written Informed Consent
  • •The clinical picture must be compatible with the presence of abscesses. Patients must have one of the following infections requiring anti-infective therapy, an operative procedure or percutaneous drainage due to:
  • •-Intra-abdominal abscess
  • •-Appendicitis with evidence of an abscess, duration of symptoms equal or more than 24 hours
  • •-Intra-abdominal abscesses related to previous intra-abdominal surgery (secondary abscesses)
  • •Patients may receive prior anti-infective therapy under the following conditions: Previous anti-infective therapy was given for < 24 hours.
  • •Are the trial subjects under 18?
  • •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
  • •Hospitalized male or female patients more or equal 18 years of age
  • •Patients with:
  • •Documented intra-abdominal abscesses by
  • •A)Either laparotomy reveals any of the following:
  • •-Intra-abdominal abscess
  • •-Macroscopic gastrointestinal perforation
  • •B)Suspected intra-abdominal abscesses and scheduled for a laparotomy by at least three of the following criteria:
  • •-Fever (Temperature > 38.0°C rectal or oral; > 38.5°C core temperature)
  • •-Leukocytosis (WBC equal or more than 12,000 cells/mm3)
  • •-Symptoms referable to the abdominal cavity (e.g. anorexia, nausea, vomiting or pain)
  • •-Tenderness (with or without rebound), absent or diminished bowel sounds or abdominal wall rigidity
  • •-Radiological evidence (Abdominal Plain Films, CT, MRI or Ultrasound) of gastrointestinal perforation or localized collections of potentially infected material
  • •Written Informed Consent
  • •The clinical picture must be compatible with the presence of abscesses. Patients must have one of the following infections requiring anti-infective therapy, an operative procedure or percutaneous drainage due to:
  • •-Intra-abdominal abscess
  • •-Appendicitis with evidence of an abscess, duration of symptoms equal or more than 24 hours
  • •-Intra-abdominal abscesses related to previous intra-abdominal surgery (secondary abscesses)
  • •Patients may receive prior anti-infective therapy under the following conditions: Previous anti-infective therapy was given for < 24 hours.
  • •Are the trial subjects under 18?
  • •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

  • •Patients with the following:
  • •An indwelling peritoneal catheter
  • •Pre-existing ascites and presumed spontaneous bacterial peritonitis
  • •Pancreatic, peripancreatic sepsis, or an intra-abdominal infection secondary to pancreatitis
  • •A perforated peptic ulcer or traumatic upper gastrointestinal tract (duodenal) perforation of < 24 hours duration
  • •A traumatic perforation of the small or large bowel of < 12 hours duration
  • •Transmural necrosis of the intestine due to acute embolic, thrombotic, or obstructive occlusions
  • •Acute cholecystitis with infection confined to the gallbladder
  • •Early acute or suppurative (no perforated) appendicitis unless there is evidence of an abscess
  • •An infection that requires treatment with an anti-infective agent other than the study drugs. Patients requiring antibiotic irrigations of the abdominal cavity or surgical wound are not suitable for entry.
  • •Require open abdomen techniques for management
  • •Infections of the female genital tract (gynaecological infections)
  • •Multiple re-laparotomies planned
  • •Known hypersensitivity to any of the study drugs
  • •Pregnancy, nursing or in whom pregnancy cannot be excluded
  • •Severe, life-threatening disease with a life expectancy of less than 48 hours or their acute physiology score and chronic health evaluation (APACHE) scores are > 25
  • •Neutropenia (neutrophil count < 1000 cells/mikroliter) due to malignancy or chemotherapy
  • •Receiving chronic treatment with known immunosuppressant therapy (including chronic treatment with > 15 mg/day of systemic prednisone or equivalent)
  • •HIV-seropositives with a CD4 count < 200 cells/mikroliter or HIV-seropositives who are receiving HAART (NOTE: HIV testing is not required for this study protocol)
  • •End stage hepatic cirrhosis (Child-Pugh C)
  • •Central or peripheral neuropathy (e.g. epilepsy or psychosis)
  • •Clinically significant bradycardia
  • •Symptomatic dysrhythmia in the medical history
  • •Known congenital or sporadic syndromes of QTc prolongation or use of concomitant medications reported to increase the QTc interval (e.g. cisapride, Class IA and III anti-arrhythmic agents [amiodarone, sotalol, disopyramide, quinidine, and procainamide])
  • •Disorder of the electrolyte balance, in particular uncorrected hypokalemia
  • •Previous history of tendinopathy with quinolones
  • •Previously enrolled in this trial or use of any investigational drug within the previous 30 days
  • •Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment
  • •Pre-treatment with a systemic (i.e. oral or parenteral) antibacterial agent for > 24 hours unless conditions, as outlined in Inclusion Criteria, can be met
  • •Patients with the following:
  • •An indwelling peritoneal catheter
  • •Pre-existing ascites and presumed spontaneous bacterial peritonitis
  • •Pancreatic, peripancreatic sepsis, or an intra-abdominal infection secondary to pancreatitis
  • •A perforated peptic ulcer or traumatic upper gastrointestinal tract (duodenal) perforation of < 24 hours duration
  • •A traumatic perforation of the small or large bowel of < 12 hours duration
  • •Transmural necrosis of the intestine due to acute embolic, thrombotic, or obstructive occlusions
  • •Acute cholecystitis with infection confined to the gallbladder
  • •Early acute or suppurative (no perforated) appendicitis unless there is evidence of an abscess
  • •An infection that requires treatment with an anti-infective agent other than the study drugs. Patients requiring antibiotic irrigations of the abdominal cavity or surgical wound are not suitable for entry.
  • •Require open abdomen techniques for management
  • •Infections of the female genital tract (gynaecological infections)
  • •Multiple re-laparotomies planned
  • •Known hypersensitivity to any of the study drugs
  • •Pregnancy, nursing or in whom pregnancy cannot be excluded
  • •Severe, life-threatening disease with a life expectancy of less than 48 hours or their acute physiology score and chronic health evaluation (APACHE) scores are > 25
  • •Neutropenia (neutrophil count < 1000 cells/mikroliter) due to malignancy or chemotherapy
  • •Receiving chronic treatment with known immunosuppressant therapy (including chronic treatment with > 15 mg/day of systemic prednisone or equivalent)
  • •HIV-seropositives with a CD4 count < 200 cells/mikroliter or HIV-seropositives who are receiving HAART (NOTE: HIV testing is not required for this study protocol)
  • •End stage hepatic cirrhosis (Child-Pugh C)
  • •Central or peripheral neuropathy (e.g. epilepsy or psychosis)
  • 另有 8 项未显示

研究者

发起方
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Medizinische Hochschule Hannover

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