The patients to be treated present with intra-abdominal abscesses (clinical or radiological or sonomorphological diagnosis)
Conditions
Interventions
Trade Name: Avalox 400 mg/250 ml Infusionslösung
Product Name: Avalox 400 mg/250 ml Infusionslösung
Product Code: BAY 12-8039
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Moxifloxac
Sponsors
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 OR 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 =65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: 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 OR 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 25 • Neutropenia (neutrophil count 15 mg/day of systemic prednisone or equivalent) • HIV-seropositives with a CD4 count 24 hours unless conditions, as outlined in Inclusion Criteria, can be met ;Exclusion criteria: 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 25 • Neutropenia (neutrophil count 15 mg/day of systemic prednisone or equivalent) • HIV-seropositives with a CD4 count 24 hours unless conditions, as outlined in Inclusion Criteria, can be met
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove efficacy of a new antibiotic regimen (Moxifloxacin plus Metronidazole) vs. a comparator regimen (Piperacillin plus Tazobactam). Primary study endpoint will be clinical success / failure rate at the Test-of-Cure visit (TOC) in the population valid for efficacy. ;Secondary Objective: Secondary study aims will be • Bacteriological response and overall response at TOC • Clinical, bacteriological and overall response at the End-of-Treatment visit (EOT) • Clinical response in patients with bacteriologically proven intra-abdominal abscess at TOC and EOT • Course of disease on the basis of clinical and laboratory parameters • Length of stay on ventilator • Duration of catecholamine therapy • Time to discharge from the hospital (total days) • Duration of hospitalization post-operatively (days) • Safety and tolerability of the study medication • Cost effectiveness of treatment regimens ;Primary end point(s): Primary study endpoint will be clinical success / failure rate at the Test-of-Cure visit (TOC) in the population valid for efficacy. ;Main Objective: To prove efficacy of a new antibiotic regimen (Moxifloxacin plus Metronidazole) vs. a comparator regimen (Piperacillin plus Tazobactam). Primary study endpoint will be clinical success / failure rate at the Test-of-Cure visit (TOC) in the population valid for efficacy. ;Secondary Objective: Secondary study aims will be • Bacteriological response and overall response at TOC • Clinical, bacteriological and overall response at the End-of-Treatment visit (EOT) • Clinical response in patients with bacteriologically proven intra-abdominal abscess at TOC and EOT • Course of disease on the basis of clinical and laboratory parameters • Length of stay on ventilator • Duration of catecholamine therapy • Time to discharge from the hospital (total days) • Duration of hospitalization post-operatively (days) • Safety and tolerability of the study medication • Cost effectiveness of treatment regimens ;Prima | — |
Countries
Germany
Contacts
Public Contact; ;
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Outcome results
None listed