Complicated intra-abdominal infections (cIAI) MedDRA version: 17.0 Level: LLT Classification code 10056570 Term: Intra-abdominal infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Avalox 400 mg / 250 ml Infusionslösung
Product Name: moxifloxacin
Product Code: BAY12-8039
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: MOXIFLOXACIN HYDROCHLORIDE
CAS Nu
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 = 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of treatment with moxifloxacin (compared to the safety of IV ertapenem followed by PO amoxicillin/clavulanate);Secondary Objective: Secondary objectives: • To evaluate musculoskeletal adverse events (arthropathy, arthritis, tendinopathy, tendon rupture, musculoskeletal pain, gait abnormality, etc) • To evaluate electrocardiogram (ECG) profiles obtained on Day 1 and Day 3 pre-treatment and post- treatment (serum peak level) • To evaluate the clinical and bacteriological response at the Test-of-Cure (TOC) visit • To evaluate the clinical response at the TOC visit among subjects with a bacteriologically confirmed complicated intra-abdominal infection (cIAI) • To evaluate the clinical and bacteriological response to treatment at a “during therapy” visit (Day 3-5) • To evaluate the clinical and bacteriological response to treatment at the End-of-Treatment (EOT) visit;Primary end point(s): The primary variable will be safety with a special focus on cardiac and musculoskeletal events.;Timepoint(s) of evaluation of this end point: Safety will be assessed the whole time while the patient is enrolled in the study (pre-treament visit, treatement day 1, during therapy visit, switch from IV to PO visit (if applicable), EOT visit, TOC visit, 3 months and 1 year follow-up visits) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To evaluate musculoskeletal adverse events (arthropathy, arthritis, tendinopathy, tendon rupture, musculoskeletal pain, gait abnormality, etc) • To evaluate electrocardiogram (ECG) profiles obtained pre- and post-treatment on Day 1 and Day 3 pre-treatment and post-treatment (serum peak level) • To evaluate the clinical and bacteriological response at the Test-of-Cure (TOC) visit • To evaluate the clinical response at the TOC visit among subjects with a bacteriologically confirmed cIAI • To evaluate the clinical and bacteriological response to treatment at a “during therapy” visit (Day 3-5) • To evaluate the clinical and bacteriological response to treatment at the End of Treatment (EOT) visit;Timepoint(s) of evaluation of this end point: Musculoskeletal adverse events will be recorded throughout the study until the 1 year follow-up visit. Study specific musculoskeletal assessments will be done on the pre-treatment visit, on the during therapy visit, on the EOT visit, the TOC visit and the 3 months and 1 year follow-up visits. ECGs will be recorded on treatment day 1 and 3 pre- and post dose. Clinical and bacteriological response will be evaluated at a during therapy visit as well as at EOT and TOC visit. | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Germany, Greece, Hungary, Latvia, Lithuania, Mexico, Peru, Romania, Russian Federation, Spain, Ukraine, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed