Efficacy and safety of Levonadifloxacin versus Teicoplanin-Azithromycin combination in hospitalized patients with Community Acquired Bacterial Pneumonia (CABP)

Not yet recruiting

• Conditions: Unspecified bacterial pneumonia,

• Registration Number: CTRI/2022/05/042613
• Lead Sponsor: Dr Anand Nikalje

Brief Summary

This is a Prospective, Open label,Randomized, Comparative, Two arm, Multi-centric, Investigator initiated studyin hospitalized patients of Community Acquired Bacterial Pneumonia (CABP).

This study aims to evaluate efficacyand safety of Levonadifloxacin and Teicoplanin-Azithromycin combination inhospitalized patients with Community Acquired Bacterial Pneumonia (CABP)

Minimum Duration of treatment will be 5days. (Duration of treatment can be extend upto 14 days as per investigator’sdiscretion.)

Primary endpoint - Clinical successrate at TOC (Test of Cure) visit

Secondary Endpoint –

i.             Clinical success rate at EOT (End ofTreatment) visit

ii.            Clinical improvement rate at visit 2(Early Assessment visit)

iii.           Microbiological success rate at EOT(End of Treatment) visit

Safety – Tolerability Endpoint: Incidence of adverse events / seriousadverse events, Incidence of Nephrotoxicity & Incidence of Thrombocytopenia

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-23
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

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

Inclusion Criteria

• Adult subjects of any gender ≥18 years Subjects must be willing to participate in the study and provide a written informed consent Subjects with diagnosed CABP (requiring hospitalization) characterized by At least two of the following Cough Production of purulent sputum Dyspnea (shortness of breath) Pleuritic chest pain At least two of the following Fever or hypothermia temperature > 38° C (100.4° F) or < 36 C (95.5° F). Hypotension with systolic blood pressure (SBP) < 90 mmHg. Heart rate > 90 beats/min Respiratory rate (RR) > 20 breaths/min At least one of the following Hypoxemia {partial pressure of arterial oxygen (PaO2)} < 60 mmHg by arterial blood gas (ABG) Physical examination findings of pulmonary consolidation (e.g. dullness on percussion, bronchial breath sounds or egophony) An elevated total white blood cell (WBC) count (>12,000 cells/mm3) or leucopenia (WBC < 4000 cells/mm3) Radiographically confirmed pneumonia, i.e. new or progressive pulmonary infiltrate on chest X-ray (CXR) or chest computed tomography (CT) scan consistent with bacterial pneumonia PSI.
• PORT Risk Class > II.

Exclusion Criteria

• The Patients must not meet any the following criteria: Subjects with history of hypersensitivity to any of the study drugs or same class of drugs Subject who have received prior Azithromycin therapy for the treatment of a current episode of CABP.
• Subjects who have received prior antibiotic therapy within the past 24 hours for the treatment of a current episode of CABP.
• Following are the exception to these criteria: Subjects who have received a single dose of short acting antibacterial drug within 24 hours of enrolment Subjects with evidence of clinical progression of CABP while on antibacterial drug therapy after at least 48 hours Subjects who have received an antibacterial drug for surgical prophylaxis and subsequently developed CABP Subjects who received any experimental drug within 30 days prior to enrolment Subjects who, in the judgment of the Investigator, are likely to be noncompliant or uncooperative during the study Subjects with any abnormality that the Investigator deems to be clinically relevant, either on medical history, systemic examination or ECG 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	Clinical improvement rate at visit 2 (Early Assessment visit) i.e. Day 4±1 from initiation of therapy

Trial Locations

Locations (10)

Ashirwad Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Charak Hospital and Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

GMERS Medical College and General Hospital; 🇮🇳 Vadodara, GUJARAT, India

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

Heritage Institute of Medical Sciences; 🇮🇳 Varanasi, UTTAR PRADESH, India

KIMS Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

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

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

MIOT International Hospitals; 🇮🇳 Chennai, TAMIL NADU, India

Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Ashirwad Hospital

🇮🇳Thane, MAHARASHTRA, India

Dr Shirkant Deshpande

Principal investigator

9822017445

writetoshrikant@rediffmail.com