A clinical trial to compare the safety of moxifloxacin given as infusion in the vein and as tablet to the safety of another treatment regimen in patients with a complicated infection of the abdominal cavity.
- Conditions
- Complicated intra-abdominal infections (cIAI)MedDRA version: 14.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2009-015578-37-HU
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
1. Hospitalized males or females 3 months to less than 18 years of age.
2. Able to obtain parental or legal guardian written informed consent and assent from subjects as applicable by local laws and regulations.
3. Expected duration of treatment with antibiotics is a minimum of 3 days administered IV, for a total of 5 to 14 days administered IV or IV followed by PO.
4. If the subject is a female of child bearing potential she must have a negative pregnancy test at the screening visit, be capable of practicing one of the following methods of contraception, and agree to continue the same method for 1 month following the TOC visit: Oral contraceptive at a stable dose for one menstrual cycle prior to the start of the study, contraceptive implant inserted at least one month prior to the start of the study, or contraceptive injection administered one month prior to the start of the study; intrauterine device; barrier method plus spermicide; spousal/partner sterility; or abstinence. Subjects taking oral contraceptives should additionally use barrier contraception plus spermicide or abstinence during study drug exposure. Lactating subjects are not to be included.
5. Subjects may be enrolled upon a surgically (laparotomy, laparoscopy, or percutaneous drainage) confirmed cIAI revealing at least one of the following:
• Gross peritoneal inflammation with purulent exudate within the abdominal cavity, and/or
• Intra-abdominal abscess, and/or
• Macroscopic intestinal perforation with diffuse peritonitis
OR
Subjects may be enrolled on the basis of a suspected cIAI, which must be supported with radiological evidence (ultrasound, abdominal plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of gastrointestinal perforation or localized collections of potentially infected material
AND
At least one of the following:
• Symptoms referable to the abdominal cavity (eg, anorexia, nausea, vomiting or pain)
• Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity
• Fever (body temperature >38.0°C (100.4°F) oral; >38.5°C (101.3°F) rectal, tympanic membrane, or temporal artery) (as of Amd 2)
• Leukocytosis (white blood cells [WBC] ³ 12,000 cells/mm³)
AND
The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) or percutaneous drainage
Are the trial subjects under 18? yes
Number of subjects for this age range: 450
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Presumed spontaneous bacterial peritonitis
2. All pancreatic processes including pancreatic sepsis, peripancreatic sepsis, or an cIAI secondary to pancreatitis
3. Early acute or suppurative (nonperforated) appendicitis unless there is evidence of an abscess or peritoneal fluid containing pus and micro organisms suggestive of regional contamination
4. Infections originating from the female genital tract
5. Known severe immunosuppression (eg, known neutropenia with absolute neutrophil count < 1000/mm³ caused by immunosuppressant therapy or malignancy, known lymphopenia with absolute CD4 + T-cell count < 200/mm³, presenting with an Acquired Immunodeficiency Syndrome [AIDS]-defining event and/or concomitant antiretroviral therapy [Note: Human immuno-deficiency virus {HIV} testing is not required for this study protocol], chronic treatment [>= 2 weeks] with known immunosuppressive therapy [including treatment with systemic prednisone or equivalent] or any other congenital or acquired immune defect or immunosuppression)
Subjects with known mild immunosuppression (eg, Type I or II diabetes mellitus, trauma, or absolute neutrophil count [ANC] between 1000 and 1500 cells/mm³) may be enrolled.
6. Subjects 1 year to less than 18 years of age need to have at least 80% of lower limit of normal (LLN) estimated glomerular filtration rate (eGFR) appropriate for age;
subjects 3 months to less than 1 year of age need to have at least 100% of LLN eGFR appropriate for age
7. History of tendon disease/disorder related to quinolone treatment
8. History of myasthenia gravis
9. Prior quinolone use within the previous 12 months
10. Systemic antibacterial treatment within the previous 7 days (a maximum of 24 hours of empiric pre- and perioperative antibiotic treatment [other than study drug] is allowed before start of study drug with the exception of quinolones)
11. Abnormal musculoskeletal findings at baseline assessment; or chronic musculoskeletal disease (eg, juvenile idiopathic arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendonitis (eg, bone or cartilage defects, juvenile idiopathic arthritis, systemic lupus erythematosus, vasculitides, dermatomyositis, Osgood Schlatter’s disease, retropatellar sydrome, fibromyalgia, cystic fibrosis, cerebral palsy, psoriasis, and chronic inflammatory bowel disease such as Crohn’s disease and ulcerative colitis)
12. Septic shock or suspected septic shock (as of Amd 2)
13. Psychotic subjects or subjects with a history of psychiatric diseases
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method