Phase II Study of Oral Nafithromycin in CABP

Wockhardt

Status and phase: Completed; Phase 2

Conditions: Community-Acquired Bacterial Pneumonia (CABP)

Treatments: Drug: Moxifloxacin 400 mg; Drug: Nafithromycin 800 mg 3 days; Drug: Nafithromycin 800 mg 5 days

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02903836

W-4873-201

Details and patient eligibility

About

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

Enrollment: 231 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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231 participants in 3 patient groups

Nafithromycin 800 mg 3 days

Experimental group

Description:

PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind

Treatment:

Drug: Nafithromycin 800 mg 3 days

Nafithromycin 800 mg 5 days

Experimental group

Description:

PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind

Treatment:

Drug: Nafithromycin 800 mg 5 days

Moxifloxacin 400 mg

Active Comparator group

Description:

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

Treatment:

Drug: Moxifloxacin 400 mg