Acute Bacterial Skin and Skin Structure InfectionsPhase 3NCT03405064
Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
A Phase 3 study testing Oral Levonadifloxacin/Linezolid Tablet and Intravenous Levonadifloxacin/Linezolid Infusion in people with Acute Bacterial Skin and Skin Structure Infections, run by Wockhardt at 32 sites in India.
Trial summary
This is a phase III, multi-center, randomized, active-comparator, study in subjects with ABSSSI. The study has two subgroups for assessment of efficacy and safety - oral subgroup 1 and IV subgroup 2. Each subgroup will comprise of two treatment arms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Bacterial Skin and Skin Structure Infections
- What is being tested?
- Oral Levonadifloxacin/Linezolid Tablet and Intravenous Levonadifloxacin/Linezolid Infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 32 sitesIndia
- Study dates
- 25 Aug 2017to 30 Nov 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be willing to participate in the study and provide a written informed consent
- Subjects with ABSSSI characterized by any of the following infection types:
- Cellulitis/erysipelas: diffuse skin infection characterized by spreading areas of redness, edema, and/or induration
- Wound infection: An infection characterized by purulent drainage from a wound with surrounding redness, edema, and/or induration
- Major cutaneous abscess: An infection characterized by a collection of pus within the dermis or deeper that is accompanied by redness, edema, and/or induration
- Subjects with lesion size area of at-least 75 cm2. Lesion size will be measured by the area of redness, edema, or induration
- Subjects with suspected and/or documented evidence of Gram-positive infection
Who cannot join
- 1. ABSSSI meeting any of the following criteria:
- Severely impaired arterial blood supply (such that the likelihood of amputation of the infected anatomical site is likely)
- ABSSSI expected to require more than 10 days of antimicrobial therapy as per the discretion of the Investigator
- Subject with suspected or confirmed osteomyelitis or septic arthritis or gangrene
- ABSSSI requiring surgical intervention (except surgical incision and drainage for abscess) 2. Subjects who have received prior antibiotic therapy within past 24 hours for the treatment of current episode of ABSSSI. Following are the exceptions to this criteria:
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- Subjects who received a single dose of a short-acting antibacterial drug within 24 hours of enrolment
- Subjects with evidence of clinical progression of ABSSSI while on antibacterial drug therapy after at-least 48 hours
- Subjects who received an antibacterial drug for surgical prophylaxis and subsequently develop ABSSSI 3. Subjects with current history or diagnosis of HIV, positive test result for hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) 4. Subjects with any clinically significant abnormalities in pulmonary, gastrointestinal, endocrine, hepatic or renal systems
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
India32 sites
Sanjivani Superspeciality Hospital Pvt. Ltd.
Ahmedabad, Gujarat, 380015
Victoria Hospital
Bangalore, Karnataka, 560002
Ishwar Institute of Healthcare
Chhatrapati Sambhajinagar, Maharashtra, 431002
Medistar Multispeciality Hospital Pvt.Ltd.
Himmatnagar, Gujarat, 383001
Osmania General Hospital
Hyderabad, Andhra Pradesh, 500012
S.R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001
SMS Hospital
Jaipur, Rajasthan, 302004
Marudhar Hospital
Jaipur, Rajasthan, 302012
Government Medical College
Kozhikode, Kerala, Kozhikode,
M.V. Hospital & Research Centre
Lucknow, Uttar Pradesh, 226003
Ajanta Research Centre
Lucknow, Uttar Pradesh, 2260055
KRM Hospital and Research Centre
Lucknow, Uttar Pradesh, 226010
Vinaya Hospital and Research Centre
Mangalore, Karnataka, 575003
TNMC & BYL Nair Hospital
Mumbai, Maharashtra, 400008
LTM Medical College and General Hospital
Mumbai, Maharashtra, 400022
Mysore Medical College and Research Institute
Mysore, Karnataka, 570001
Government Medical College and Hospital
Nagpur, Maharashtra, 440003
Shree Hospital & Critical Care Centre
Nagpur, Maharashtra, 440003
Rahate Surgical Hospital
Nagpur, Maharashtra, 440008
Cresent Hospital and Heart Centre
Nagpur, Maharashtra, 440012
Indira Gandhi Government Medical College and Hospital
Nagpur, Maharashtra, 440018
B.J. Medical College and Sassoon General Hospital
Pune, Maharashtra, 411001,
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004
Oyster & Pearl Hospital
Pune, Maharashtra, 411005
Noble Hospital
Pune, Maharashtra, 411013
Lifepoint Hospital
Pune, Maharashtra, 411057
GMERS Medical College & General Hospital
Vadodara, Gujarat, 390021
Parul Institute of Medical Science
Vadodara, Gujarat, 391760
Popular Hospital
Varanasi, Uttar Pradesh, 221009
Om Surgical & Maternity Home
Varanasi, Uttar Pradesh, 22100
Government General Hospital (Associated by Government Siddhartha Medical College)
Vijayawada, Andhra Pradesh, 520008
Datta Meghe Institute of Medical Sciences (Deemed University) Jawaharlal Nehru Medical College
Wardha, Maharashtra, 442004
About this study
Official title: A Phase III, Multi-centre, Randomized Study to Compare the Efficacy and Safety of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
This is a phase III, multi-center, randomized, active-comparator, study in subjects with ABSSSI. The study has two subgroups for assessment of efficacy and safety - oral subgroup 1 and IV subgroup 2. Each subgroup will comprise of two treatment arms.
Read the detailed description
Subjects willing to participate in the study and fulfilling all eligibility criteria will receive either oral therapy (subgroup 1) or IV therapy (subgroup 2). The investigator can initiate treatment with either oral or IV therapy based on clinical judgement i.e subjects who require IV therapy (like subjects with severe ABSSSI or where oral administration is not feasible).
- Being tested
- Oral Levonadifloxacin/Linezolid Tablet, Intravenous Levonadifloxacin/Linezolid Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Levonadifloxacin/Linezolid TabletDrug
oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)
Intravenous Levonadifloxacin/Linezolid InfusionDrug
IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)
| Study group | Role | What they receive |
|---|---|---|
| levonadifloxacin | Experimental | oral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID) Receives: Drug: Oral Levonadifloxacin/Linezolid Tablet; Drug: Intravenous Levonadifloxacin/Linezolid Infusion |
| linezolid | Active comparator | oral linezolid (600 mg BID) or IV linezolid (600 mg BID) Receives: Drug: Oral Levonadifloxacin/Linezolid Tablet; Drug: Intravenous Levonadifloxacin/Linezolid Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The non-inferiority of oral levonadifloxacin with oral linezolid in ABSSSI by measuring the Overall Clinical Response at Test of Cure (TOC) visit in modified Intentto-treat (mITT) population in oral treatment subgroups
Measured: 0-14 days
To establish the non-inferiority of IV levonadifloxacin with IV linezolid in ABSSSI measuring the Overall Clinical Response at Test of Cure (TOC) visit in modified Intentto-treat (mITT) population in IV treatment subgroups
Measured: 0-14 days
Secondary outcomes (1)
The safety of oral and IV levonadifloxacin based on adverse events reported, vital signs and physical examination findings, clinical laboratory evaluation, and ECG collected during the study.
Measured: 0-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start25 Aug 2017
- Primary completion25 Sep 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Bacterial Skin and Skin Structure InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rakesh Chugh, MD, Study director, Wockhardt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405064
- Sponsor's protocol ID
- W-771/2349-301
- Status last verified
- Jun 2020
- First submitted
- 22 Nov 2017
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhatia A, Mastim M, Shah M, Gutte R, Joshi P, Kumbhar D, Periasamy H, Palwe SR, Chavan R, Bhagwat S, Patel M, Llorens L, Friedland HD. Efficacy and Safety of a Novel Broad-Spectrum Anti-MRSA Agent Levonadifloxacin Compared with Linezolid for Acute Bacterial Skin and Skin Structure Infections: A Phase 3, Openlabel, Randomized Study. J Assoc Physicians India. 2020 Aug;68(8):30-36.
PubMed 32738837
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-centre, Randomized Study to Compare the Efficacy and Safety of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
- ClinicalTrials.gov ID
- NCT03405064
- Acronym / sponsor ID
- W-771/2349-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III, multi-center, randomized, active-comparator, study in subjects with ABSSSI. The study has two subgroups for assessment of efficacy and safety - oral subgroup 1 and IV subgroup 2. Each subgroup will comprise of two treatment arms.
Detailed description
Subjects willing to participate in the study and fulfilling all eligibility criteria will receive either oral therapy (subgroup 1) or IV therapy (subgroup 2). The investigator can initiate treatment with either oral or IV therapy based on clinical judgement i.e subjects who require IV therapy (like subjects with severe ABSSSI or where oral administration is not feasible).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levonadifloxacin | Experimental | Drug: Oral Levonadifloxacin/Linezolid Tablet, Drug: Intravenous Levonadifloxacin/Linezolid Infusionoral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID) |
| linezolid | Active comparator | Drug: Oral Levonadifloxacin/Linezolid Tablet, Drug: Intravenous Levonadifloxacin/Linezolid Infusionoral linezolid (600 mg BID) or IV linezolid (600 mg BID) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must be willing to participate in the study and provide a written informed consent
- Subjects with ABSSSI characterized by any of the following infection types:
- Subjects with lesion size area of at-least 75 cm2. Lesion size will be measured by the area of redness, edema, or induration
- Subjects with suspected and/or documented evidence of Gram-positive infection
Key exclusion criteria (9 listed)
- 1. ABSSSI meeting any of the following criteria:
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Levonadifloxacin/Linezolid Tabletoral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID) | Drug | levonadifloxacin, linezolid |
| Intravenous Levonadifloxacin/Linezolid InfusionIV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID) | Drug | levonadifloxacin, linezolid |
Primary outcome
The non-inferiority of oral levonadifloxacin with oral linezolid in ABSSSI by measuring the Overall Clinical Response at Test of Cure (TOC) visit in modified Intentto-treat (mITT) population in oral treatment subgroups
Time frame: 0-14 days
To establish the non-inferiority of IV levonadifloxacin with IV linezolid in ABSSSI measuring the Overall Clinical Response at Test of Cure (TOC) visit in modified Intentto-treat (mITT) population in IV treatment subgroups
Time frame: 0-14 days
1 secondary outcome
The safety of oral and IV levonadifloxacin based on adverse events reported, vital signs and physical examination findings, clinical laboratory evaluation, and ECG collected during the study.
Time frame: 0-14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Derived from this study: PubMed 32738837Bhatia A, Mastim M, Shah M, Gutte R, Joshi P, Kumbhar D, Periasamy H, Palwe SR, Chavan R, Bhagwat S, Patel M, Llorens L, Friedland HD. Efficacy and Safety of a Novel Broad-Spectrum Anti-MRSA Agent Levonadifloxacin Compared with Linezolid for Acute Bacterial Skin and Skin Structure Infections: A Phase 3, Openlabel, Randomized Study. J Assoc Physicians India. 2020 Aug;68(8):30-36.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakesh Chugh, MD study director
Wockhardt
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Levonadifloxacin/Linezolid Tablet and Intravenous Levonadifloxacin/Linezolid Infusion in people with Acute Bacterial Skin and Skin Structure Infections, run by Wockhardt at 32 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The non-inferiority of oral levonadifloxacin with oral linezolid in ABSSSI by measuring the Overall Clinical Response at Test of Cure (TOC) visit in modified Intentto-treat (mITT) population in oral treatment subgroups (time frame: 0-14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03405064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.