Phase II Study of Oral Nafithromycin in CABP

Wockhardt231 enrolled

Overview

Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

231

Conditions

Community-Acquired Bacterial Pneumonia (CABP)

Interventions

Nafithromycin 800 mg 3 daysDRUG

Nafithromycin 800 mg 5 daysDRUG

Moxifloxacin 400 mgDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Meet the clinical criteria for CABP based on following: 1. Clinical symptoms (new or worsening) 2. Vital sign abnormalities 3. Laboratory abnormalities 4. Radiographic evidence of CABP 5. PORT score Exclusion Criteria: 1. Subjects with any of the following confirmed or suspected types of pneumonia: 1. Aspiration pneumonia 2. Hospital-acquired bacterial pneumonia (HABP) 3. Healthcare-associated bacterial pneumonia (HCAP) 4. Ventilator-associated bacterial pneumonia (VABP) 5. Pneumonia that may be caused by pathogen(s) resistant to either study drug 2. Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial treatment for treatment of the current CABP 3. Suspected or confirmed non-infectious causes of pulmonary infiltrates 4. Subjects requiring concomitant adjunctive or additional potentially-effective systemic antibacterial treatment for management of CABP

Locations (6)

A & L Clinical research

Miami, Florida, United States

A Plus Research Inc.

Miami, Florida, United States

RM Medical Research, Inc.

Miami, Florida, United States

Empire Clinical Research, LLC

Miami Lakes, Florida, United States

Outcomes

Primary Outcomes

Clinical Response in the ITT Population

The primary efficacy endpoint was clinical response (response, non-response, or indeterminate) at Day 4, tested in the ITT population. Clinical response was determined programmatically using the investigator's assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Severity Guidance

Time frame: Day 4 from start of drug administration

Secondary Outcomes

Clinical Response in the Micro-ITT Population

Clinical response (response, non-response, or indeterminate) at Day 4 was also tested in the micro-ITT population as a secondary efficacy endpoint. Clinical response was determined programmatically using the investigator's assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Severity Guidance

Time frame: Day 4 from start of drug administration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.