Phase II Study of Oral Nafithromycin in CABP

Phase 2

Completed

• Conditions: Community-Acquired Bacterial Pneumonia (CABP)
• Interventions: Drug: Moxifloxacin 400 mg; Drug: Nafithromycin 800 mg 5 days; Drug: Nafithromycin 800 mg 3 days

• Registration Number: NCT02903836
• Lead Sponsor: Wockhardt

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-16
• Study Start: 2016-11-18
• Primary Completion: 2017-07
• Study Completion: 2017-07-08
• Results First Submitted: 2019-02-27
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-19
• Last Update Submitted: 2019-12-19
• Results First Posted: 2019-12-20
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Moxifloxacin 400 mg	Moxifloxacin 400 mg	PO q24h for 7 days;subjects will also receive two nafithromycin placebo tablets PO q24h on Days 1 through Day 7 to maintain the blind
Nafithromycin 800 mg 5 days	Nafithromycin 800 mg 5 days	PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind
Nafithromycin 800 mg 3 days	Nafithromycin 800 mg 3 days	PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind

Primary Outcome Measures

Name	Time	Method
Clinical Response in the ITT Population	Day 4 from start of drug administration	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

Secondary Outcome Measures

Name	Time	Method
Clinical Response in the Micro-ITT Population	Day 4 from start of drug administration	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

Trial Locations

Locations (6)

Health Concepts; 🇺🇸 Bedford, South Dakota, United States

A & L Clinical research; 🇺🇸 Miami, Florida, United States

A Plus Research Inc.; 🇺🇸 Miami, Florida, United States

Empire Clinical Research, LLC; 🇺🇸 Miami Lakes, Florida, United States

RM Medical Research, Inc.; 🇺🇸 Miami, Florida, United States

HCI Metromedic Walkin Medical Center; 🇺🇸 Bedford, Massachusetts, United States