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Avelox · 7 trials · 9 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Avelox (Moxifloxacin, BAY12-8039) | DRUG | Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days. |
| Amoxicilline/clavulanic | DRUG | IV Amoxicilline/clavulanic acid 2000/200 mg TID followed by PO amoxicilline/clavulanate 875/125 mg TID for a total of 7 to 21 days |
| Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin | DRUG | IV therapy: every 24 hours patients will be administered a 2 g ceftriaxone infusion over 30 minutes. Following the infusion with ceftriaxone, patients will be administered a 500 mg azithromycin infusion over 180 minutes.Oral therapy: every 8 hours patients will be administered a 1000 mg amoxicillin/clavulanic acid tablet. Every 12 hours patients will be administered a 500 mg clarithromycin tablet. |
| Ceftriaxone + Metronidazole | DRUG | Ceftriaxone 2 g every 24 h and Metronidazole 500 mg every 12 h |
| Placebo | DRUG | Matching placebo capsules orally once daily for 5 days every 8 weeks. |
| Levofloxacin + Ceftriaxone | DRUG | Intravenous combination therapy of levofloxacin 500 mg twice daily and ceftriaxone (2 g once a day) followed by oral levofloxacin (500 mg twice a day for 7 to 14 days). |
| Sulbactam/Ampicillin | DRUG | Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid |
Inclusion Criteria: * Written informed consent * Men or women of age \>/= 18 years with a diagnosis of bacterial skin and skin structure infection that requires * Hospitalization * Initial parenteral therapy for at least 48 hours * Complicated by at least one of the following criteria: * In...
Avelox is an antibiotic studied for treating several types of infection, including aspiration pneumonia, lung abscess, complicated intra-abdominal infections, and complicated skin and skin structure infections. It has also been evaluated in healthy volunteers to assess its effect on the QTc interval on electrocardiography.
Avelox is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor behind the clinical trial program evaluating moxifloxacin, also known by the development code BAY12-8039, across infectious disease and pneumonia indications.
Avelox has been studied in Phase 3 clinical development, with completed Phase 3 trials in aspiration pneumonia, lung abscess, complicated intra-abdominal infections, and complicated skin and skin structure infections, plus a Phase 1 QTc validation study in healthy subjects. No trials in this program are currently active.
The Avelox program includes completed trials NCT01045902 in pulmonary abscess and aspiration pneumonia, NCT01014247 evaluating QTc interval effects in healthy subjects, NCT00828971 in complicated skin and skin structure infections, and NCT00769171, the Dragon study, in complicated intra-abdominal infections. All four trials are completed.
Yes. Avelox is the brand name for moxifloxacin, which is also identified by the development code BAY12-8039. Searches for Avelox, moxifloxacin, and BAY12-8039 all refer to the same small molecule antibiotic developed by Bayer AG.
Across the four completed trials in this program, 573 patients and volunteers were enrolled, including 139 in the aspiration pneumonia and lung abscess study, 56 healthy subjects in the QTc study, 16 in the complicated skin infection study, and 364 in the Dragon intra-abdominal infection study.