A P3 Comparator Trial in Community Acquired Bacterial Pneumonia

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc
• Treatments: Azithromycin; Dalbavancin; Linezolid; Teicoplanin

Criteria

Inclusion Criteria:

1. Adults aged 18 to 85, inclusive

2. Has given written, informed consent

3. Has acute illness with onset within previous 7 days

4. Has at least 2 of the following symptoms:

• Difficulty breathing or shortness of breath

• Cough

• Production of purulent sputum

• Pleuritic chest pain

5. Has at least 2 vital sign abnormalities:

• Fever (> 38°C or < 35°C)

• Hypotension (systolic BP < 90 mm Hg)

• Tachycardia (> 100 beats /min)

• Tachypnea (> 24 breaths /min)

6. Has at least one other clinical or laboratory abnormalities:

• Hypoxemia (room air SaO2 < 90% )

• Clinical evidence of pulmonary consolidation

• Elevated WBC count or neutropenia (> 12,000/mm3 or < 4,000/mm3)

7. Has new lobar or multi-lobar infiltrates on chest radiograph

8. Has CURB-65 risk category 1 to 4. Patients with CURB-65 risk category 1 will be limited to 20% of the total patient population

Exclusion Criteria:

1. Contra-indication to the administration of any of the study treatments, such as hypersensitivity to any of the glycopeptide agents, beta-lactam agents, linezolid or macrolide antibiotics, or current or recent (within 2 weeks) use of MAO inhibitors or serotonergic antidepressants (within 5 weeks for fluoxetine) (see Section 5.5.1)

2. Has received antibiotic therapy in the 4 days prior to screening, with the following exception: up to 25% of patients may have received a single dose of a short acting (half life < 8 hours) antibiotic

3. Has aspiration pneumonia

4. Has hospital acquired or ventilator associated pneumonia, or healthcare associated pneumonia, or 2 or more days in hospital in the previous 90 days

5. Has cystic fibrosis or known or suspected Pneumocystis pneumonia or known or suspected active tuberculosis

6. Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant

7. Has primary or metastatic lung cancer

8. Has known bronchial obstruction or a history of post-obstructive pneumonia

9. Requires admission to ICU at baseline

10. Has empyema requiring drainage

11. Infection due to an organism known prior to study entry to be resistant to either treatment regimen

12. Has known or suspected infection due solely to an atypical pathogen such as Mycoplasma sp., Chlamydia sp. or Legionella sp. or positive Legionella urinary antigen at baseline

13. Absolute neutrophil count < 500 cells/mm3

14. Known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count < 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count

15. Patients with a recent bone marrow transplant (in post-transplant hospital stay)

16. Patients receiving oral steroids > 40 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation

17. Patients with a rapidly fatal illness, who are not expected to survive for 3 months

18. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study

19. Has participated in another trial of an investigational pharmaceutical product in the 30 days prior to enrollment

20. Prior participation in this trial.