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Avelox

Phase 3

Infection, Intra-abdominal | Small molecule | Other |Bayer AG|Last Updated: Dec 18, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment364

FDA Designations

No designations recorded

Clinical trial landscape

Avelox · 7 trials · 9 indications

Phase 3 6Phase 1 1
NCT00828971A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIsInfectious Diseases
COMPLETED16 Analytics
NCT00717561A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired PneumoniaPneumonia
COMPLETED60 Analytics
NCT00769171Dragon Study (the Safety and Efficacy for Treatment of Patients With Complicated Intra Abdominal Infections)Infection, Intra-abdominal
COMPLETED364 Analytics
NCT00473460Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic BronchitisLung Diseases
COMPLETED1,404 Analytics
NCT00431678Efficacy and Safety of Sequential IV/PO Moxifloxacin in Comparison to IV Levofloxacin Plus IV Ceftriaxone Followed by PO Levofloxacin, in the Treatment of Patients With Community-acquired PneumoniaPneumonia
COMPLETED738 Analytics
NCT01045902BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration PneumoniaPneumonia, Aspiration
COMPLETED139 Analytics
PHASE3COMPLETED
A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs
Infectious DiseasesUnlock trial analytics
PHASE3COMPLETED
A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia
PneumoniaUnlock trial analytics
PHASE3COMPLETED
Dragon Study (the Safety and Efficacy for Treatment of Patients With Complicated Intra Abdominal Infections)
Infection, Intra-abdominalUnlock trial analytics
PHASE3COMPLETED
Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis
Lung DiseasesUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Sequential IV/PO Moxifloxacin in Comparison to IV Levofloxacin Plus IV Ceftriaxone Followed by PO Levofloxacin, in the Treatment of Patients With Community-acquired Pneumonia
PneumoniaUnlock trial analytics
PHASE3COMPLETED
BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia
Pneumonia, AspirationUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]).
Test-of-Cure visit [TOC].
Clinical response 20 days after completion of study treatment (Test-of-Cure visit)
20 days after last dose of study drug (TOC Visit)
Clinical Response
After 10-14 days of treatment
Number of exacerbations after 48 weeks of intermittent pulse treatment
After 48 weeks of treatment
Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events
Up to 30 days after end of treatment with study medication for serious adverse events
QTc interval at 3 hours
Day 1 of treatment period 1 and 2

Secondary Endpoints

Clinical response assessed by the investigator on treatment Day 3-5
Day 3-5
Clinical response assessed by the investigator at the end-of-therapy (EOT).
At the end-of-therapy (EOT)
Time to switch from oral to IV therapy
Day of switch from oral to IV therapy
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Avelox (Moxifloxacin, BAY12-8039)DRUGSequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.
Amoxicilline/clavulanicDRUGIV 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; ClarithromycinDRUGIV 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 + MetronidazoleDRUGCeftriaxone 2 g every 24 h and Metronidazole 500 mg every 12 h
PlaceboDRUGMatching placebo capsules orally once daily for 5 days every 8 weeks.
Levofloxacin + CeftriaxoneDRUGIntravenous 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/AmpicillinDRUGSulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

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...

Countries:ItalyChinaHong KongIndonesiaMalaysiaSouth KoreaTaiwanUnited StatesAndorraArgentinaBrazilChileFranceGermanyGreeceIrelandIsraelMexicoSouth AfricaSpainUnited KingdomBelgiumColombiaLithuaniaNetherlandsPeruPolandPortugalSwedenAustraliaSingapore
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Frequently asked questions about Avelox

What is Avelox used for?

Avelox is an antibiotic used for infections, including complicated intra-abdominal infections, aspiration pneumonia, and lung abscess. It has also been studied for preventing acute exacerbations in chronic bronchitis. Avelox is a small molecule developed by Bayer AG.

What does Avelox target?

Avelox targets bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication. By inhibiting these targets, Avelox exerts its antibacterial effect. This mechanism is based on its classification as a fluoroquinolone antibiotic.

Who makes Avelox?

Avelox is developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The drug is a small molecule antibiotic.

What phase is Avelox in?

Avelox is in Phase 3 clinical development. It has completed multiple Phase 3 trials, including studies for chronic bronchitis, complicated intra-abdominal infections, and aspiration pneumonia. Avelox is investigational and not yet approved for these indications.

What clinical trials is Avelox in?

Avelox has been studied in several clinical trials. NCT00473460 evaluated intermittent therapy for chronic bronchitis prevention. NCT00769171 studied treatment for complicated intra-abdominal infections. NCT01014247 assessed QTc interval effects. NCT01045902 investigated pulmonary abscess and aspiration pneumonia.

Is Avelox the same as moxifloxacin?

Yes, Avelox is the brand name for moxifloxacin, a fluoroquinolone antibiotic. Clinical trials listed under Avelox often use moxifloxacin as the drug name. This includes studies like NCT00473460 and NCT00769171, which refer to moxifloxacin therapy.