Phase II Study of Oral Nafithromycin in CABP

Community-Acquired Bacterial Pneumonia (CABP) Clinical Trial

Official title:

A Phase II, Randomized, Double-Blind, Multicenter, Comparative 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903836
• Other study ID #: W-4873-201
• Status: Completed
• Phase: Phase 2
• Start date: November 18, 2016
• Est. completion date: July 8, 2017

Study information

• Verified date: December 2019
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: July 8, 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Community-Acquired Bacterial Pneumonia (CABP)
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Nafithromycin 800 mg 3 days

• Nafithromycin 800 mg 5 days

• Moxifloxacin 400 mg

Locations

Country	Name	City	State
United States	HCI Metromedic Walkin Medical Center	Bedford	Massachusetts
United States	Health Concepts	Bedford	South Dakota
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Wockhardt	ACM

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 4 from start of drug administration
Secondary	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	Day 4 from start of drug administration