CompletedPhase 3

Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

India501 participantsStarted 2017-08-25

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion 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:
✕. 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

What they're measuring

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

Timeframe: 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

Timeframe: 0-14 days

Trial details

NCT IDNCT03405064

SponsorWockhardt

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-25

View on ClinicalTrials.gov More Acute Bacterial Skin and Skin Structure Infections trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion 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:
✕. 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

What they're measuring

Timeframe: 0-14 days