EEfficacy and safety of Levonadifloxacin with Teicoplanin-Aztreonam combination in patients with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) including diabetic foot infection

Not yet recruiting

• Conditions: Other specified local infections of the skin and subcutaneous tissue,

• Registration Number: CTRI/2022/06/043031
• Lead Sponsor: Dr Anand Nikalje

Brief Summary

This is a Prospective, Open label, Randomized, Comparative,Two arm, Multi-centric, Investigator initiated study in hospitalized patientsof Acute Bacterial Skin and Skin Structure Infection (ABSSSI) includingdiabetic foot infection

This study aims to efficacy and safety of Levonadifloxacinand Teicoplanin-Aztreonam combination in hospitalized patients with AcuteBacterial Skin and Skin Structure Infection (ABSSSI).

Minimum Duration oftreatment will be 7 days. (Duration of treatment can be extend upto 14 days asper investigator’s discretion.)

Primary endpoint : Clinical success rate at TOC (Test ofCure) visit

Secondary endpoint : Clinical success rate at EOT (End ofTreatment) visit

Clinical improvement rate at visit 2 (Early Assessment visit)

Microbiological success rate at EOT (End of Treatment) visit

Safety –Tolerability Endpoint: Incidence of adverse events / serious adverse events(Incidence of Nephrotoxicity) & Incidence of Thrombocytopenia

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-15
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Adult subjects of any gender ≥18 years 2.
• Subjects must be willing to participate in the study and provide a written informed consent 3.
• Subjects with diagnosed ABSSSI (requiring hospitalization) characterized by any of the following infection types: a.Cellulitis / Erysipelas: diffuse skin infection characterized by spreading areas of redness, oedema and induration b.Wound infection: An infection characterized by purulent drainage from a wound with surrounding redness, oedema and / or induration c.Major cutaneous abscess: An infection characterized by a collection of pus within the dermis or deeper that was accompanied by redness, oedema and/or induration d.Diabetic foot infection 4.
• Subjects with lesion size area of at least 75 cm2, lesion size was measured by the area of redness, oedema or induration 5.
• Subjects with suspected and / or documented evidence of Gram positive infection.

Exclusion Criteria

• 1.Subjects with history of hypersensitivity to any of the study drugs or same class of drugs 2.Subjects who have received prior antibiotic therapy within the past 24 hours for the treatment of a current episode of ABSSSI.
• Followings are the exception to these criteria: a.Subjects who have received a single dose of short acting antibacterial drug within 24 hours of enrolment b.Subjects with evidence of clinical progression of ABSSSI while on antibacterial drug therapy after at least 48 hours c.Subjects who have received an antibacterial drug for surgical prophylaxis and subsequently developed ABSSSI 3.Subjects who received any experimental drug within 30 days prior to enrolment 4.Subjects who, in the judgment of the Investigator, are likely to be noncompliant or uncooperative during the study 5.Subjects with any abnormality that the Investigator deems to be clinically relevant, either on medical history, systemic examination, or ECG, 6.Subjects on hemodialysis or creatinine clearance ≤ 30 mL/min (estimated by Cockcroft Gault equation).
• Subjects with abnormal platelet count < 1,50,000 cells/mm3.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical success rate at TOC (Test of Cure) visit	Day 7±1 to 14 from initiation of therapy

Secondary Outcome Measures

Name	Time	Method
Clinical success rate at EOT (End of Treatment)	visit i.e. Day 7±1 to 14

Trial Locations

Locations (11)

Accord Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Acharya Vinoba Bhave Rural Hospital; 🇮🇳 Wardha, MAHARASHTRA, India

Bhagwan Mahavir Medica Super Speciality Hospital; 🇮🇳 Ranchi, JHARKHAND, India

Government Medical College Kozhikode; 🇮🇳 Kozhikode, KERALA, India

Grant Government Medical College & Sir J J Group of Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Hansa Clinic and Hospital; 🇮🇳 DAMAN, & DIU, India

Mahatma Gandhi Medical College and Research Institute, Puducherry; 🇮🇳 Pondicherry, PONDICHERRY, India

Malabar Medical College Hospital and Research Centre; 🇮🇳 Kozhikode, KERALA, India

MGM Medical College and Hospital; 🇮🇳 Aurangabad, MAHARASHTRA, India

Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital; 🇮🇳 Thane, MAHARASHTRA, India

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Accord Multispeciality Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Pratik D Ajagekar

Principal investigator

9067847843

pratik.ajagekar@gmail.com