Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Moxifloxacin (BAY12-8039)
Moxifloxacin · 9 trials · 14 indications
An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by \> 70% and apyrexia (rectal/tympanic/oral temperature value \< 38.0°C or axillary temperature value \< 37.5°C) and white blood cell count \< 10,500/mm\^3.
Clinical response was evaluated by the DRC and graded as "cure", "failure" or "indeterminate" at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.
Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.
clinical success
The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Joint assessment included formal physical examination of all joints with special care and attention to the weight-bearing joints (such as, knees, hips, and ankles) and to the shoulder girdle. All joints were examined for pain/tenderness, evidence of inflammation (i.e., redness, warmth, deformity, swelling or ballotable fluid), loss of function (to the extent this could be assessed in younger children and infants), and any restrictions to expected active/passive range of motion. An incidence count was reported as the number of subjects with at least one finding at baseline, regardless of side.
Joint assessment included formal physical examination of all joints with special care and attention to the weight-bearing joints (such as, knees, hips, and ankles) and to the shoulder girdle. An incidence count was reported as the number of subjects with at least one finding at any time during treatment, regardless of side.
| Arm | Type | Description |
|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | EXPERIMENTAL | Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days. |
| Comparator Ertapenem | ACTIVE_COMPARATOR | Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days. |
| Moxifloxacin | EXPERIMENTAL | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days |
| Levofloxacin plus Metronidazole | ACTIVE_COMPARATOR | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
| PIP/TAZ-AMC | ACTIVE_COMPARATOR | Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory. |
| Ertapenem | ACTIVE_COMPARATOR | Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours. |
| 1 | EXPERIMENTAL | For adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 1: Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. |
| 2 | ACTIVE_COMPARATOR | For adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 2: Piperacillin / Tazobactam 4,5 g administered intravenously three times daily |
| Moxifloxacin 400 mg | EXPERIMENTAL | Moxifloxacin 400mg once daily for 5 days |
| Placebo | PLACEBO_COMPARATOR | Matching placebo for 5 days |
| Part 1 - Dose group 1 | EXPERIMENTAL | Single oral dose of elinzanetant or placebo. |
| Part 1 - Dose group 2 | EXPERIMENTAL | Single oral dose of elinzanetant or placebo |
| Part 1 - Dose group 3 | EXPERIMENTAL | Single oral dose of elinzanetant or placebo |
| Part 1 - Dose group 4 | EXPERIMENTAL | Single oral dose of elinzanetant or placebo |
| Part 2: Moxifloxacin - Placebo | EXPERIMENTAL | Participants of Dose Groups 1 and 4 will receive a single dose of moxifloxacin in Period 1 and a single dose of placebo in Period 2. |
| Part 2: Placebo - Moxifloxacin | EXPERIMENTAL | Participants of Dose Groups 1 and 4 will receive a single dose of placebo in Period 1 and a single dose of moxifloxacin in Period 2. |
| Moxifloxacin (Avelox, BAY12-8039), Cohort 1 | EXPERIMENTAL | - |
| Moxifloxacin (Avelox, BAY12-8039), Cohort 2 | EXPERIMENTAL | - |
| Moxifloxacin (Avelox, BAY12-8039), Cohort 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | DRUG | For subjects 12 to less than (\<) 18 years of age and weighing at least 45 kilograms (kg), the dose of moxifloxacin will be 400 milligrams (mg), once daily (OD). Subjects 12 to \< 18 years of age and weighing less than 45 kg, the dose of moxifloxacin will be 4 mg/kg twice daily (BID), every 12 hours (q12h), not exceeding 400 mg/day. Subjects 6 to \< 12 years of age the dose of moxifloxacin will be 4mg/kg, q12h, not exceeding 400 mg/day. Subjects 2 to less than 6 years of age the dose of moxifloxacin will be 5mg/kg, q12h, not exceeding 400 mg/day. Subjects 3 months to less than 2 years of age the dose of moxifloxacin will be 6mg/kg q12h IV, not exceeding 400 mg/day. Subjects who were switched from IV to PO therapy, 400 mg or 50 mg moxifloxacin tablets were provided. |
| Ertapenem | DRUG | For subjects 13 to \<18 years of age, the dosage of ertapenem was 1 gram (g) OD. For subjects 3 months to \< 13 years of age, the dosage was 15 mg/kg q12h not to exceed 1 g/day. |
| Amoxicillin/Clavulanate | DRUG | Subjects 2 years to \< 18 years of age who were switched from IV to PO therapy receive amoxicillin/clavulanate suspension. The dosage of clavulanate was 3.2 mg/kg q12h. (maximum dose of clavulanate was 125 mg q12h). The dosage of amoxicillin was 22.5 mg q12h (a maximum dose of 875 mg amoxicillin q12h must not be exceeded). |
| Moxifloxacin placebo | DRUG | Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV moxifloxacin. Tablets containing inactive ingredients were used as the placebo for PO moxifloxacin 400 mg and 50 mg tablets. |
| Ertapenem placebo | DRUG | Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV ertapenem. |
| Amoxicillin/Clavulanate placebo | DRUG | Suspension containing inactive ingredients was used as the placebo for PO amoxicillin/clavulanate suspension. |
| Levofloxacin & Metronidazole | DRUG | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
| moxifloxacin | DRUG | - |
| cholecystectomy | PROCEDURE | - |
| Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid | DRUG | Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory. |
| Ertapenem intravenous | DRUG | Active treatment: Ertapenem 1.0g, administered intravenously once daily |
| Moxifloxacin/Metronidazole or Piperacillin/Tazobactam | DRUG | Antibiotic therapy for patients with intra-abdominal abscesses; Intervention consists of antibiotic treatment of the patients with intraabdominal abscess with either the combination of Moxifloxacin and Metronidazole or Piperacillin/Tazobactam.1. Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered intravenously three times daily. |
| Placebo | DRUG | Placebo - 380 mg Microcrystalline Cellulose |
| Elinzanetant (BAY3427080) | DRUG | Single oral dose of elinzanetant |
Inclusion Criteria: * Hospitalized males or females 3 months to 17 years of age * Able to obtain parental or legal guardian written informed consent and assent from subjects as applicable by local laws and regulations * Expected duration of treatment with antibiotics is a minimum of 3 days administ...
Moxifloxacin is an antibiotic used to treat bacterial infections, including intra-abdominal infections, complicated intra-abdominal infections in pediatric patients, intra-abdominal abscesses, acute cholecystitis, and pelvic inflammatory disease. It is also studied in combination with metronidazole or piperacillin/tazobactam for intra-abdominal abscesses.
Moxifloxacin is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer AG is the company responsible for the clinical development of moxifloxacin and its combinations.
Moxifloxacin has been studied in Phase 3 clinical trials. The Phase 3 trials include NCT01069900 in pediatric subjects with complicated intra-abdominal infection and NCT00629135 comparing moxifloxacin plus metronidazole versus piperacillin/tazobactam for intra-abdominal abscesses.
Moxifloxacin has been evaluated in completed clinical trials including NCT05481528, a Phase 1 study in healthy participants; NCT01069900, a Phase 3 trial in pediatric subjects with complicated intra-abdominal infection; NCT01049022, a Phase 1 study in pediatric patients; and NCT00629135, a Phase 3 trial in patients with intra-abdominal abscesses.
Yes, Moxifloxacin is also known as Avelox and BAY12-8039. Additionally, the combination of moxifloxacin with metronidazole or piperacillin/tazobactam is sometimes referred to under the same name in study contexts.