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

• Conditions: The patients to be treated present with intra-abdominal abscesses (clinical or radiological or sonomorphological diagnosis)

• Registration Number: EUCTR2005-002634-35-DE
• Lead Sponsor: Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Medizinische Hochschule Hannover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-06
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

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 < 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
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 < 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

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 < 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)
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified