Trial Outcomes & Findings for Safety and Efficacy Study of Oxazolidinone to Treat Pneumonia (NCT NCT00640926)
NCT ID: NCT00640926
Last Updated: 2016-05-12
Results Overview
Patients were considered cured if all systemic signs and symptoms of CAP present at screening were improved or resolved and no further antibiotic therapy was necessary. In addition, the follow-up chest X-ray was to be either stable or improved.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
158 participants
Primary outcome timeframe
Study days 14-38
Results posted on
2016-05-12
Participant Flow
This study targeted adult patients with mild to moderate (i.e., CURB-65 score of 0 or 1) community-acquired pneumonia (CAP).
Participant milestones
| Measure |
Radezolid 300 mg PO Daily (QD)
|
Radezolid 450 mg PO Daily (QD)
|
Radezolid 450 mg PO Twice Daily (BID)
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
53
|
|
Overall Study
COMPLETED
|
45
|
46
|
45
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
8
|
Reasons for withdrawal
| Measure |
Radezolid 300 mg PO Daily (QD)
|
Radezolid 450 mg PO Daily (QD)
|
Radezolid 450 mg PO Twice Daily (BID)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Oxazolidinone to Treat Pneumonia
Baseline characteristics by cohort
| Measure |
Radezolid 300 mg PO Daily (QD)
n=53 Participants
|
Radezolid 450 mg PO Daily (QD)
n=52 Participants
|
Radezolid 450 mg PO Twice Daily (BID)
n=53 Participants
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 18.37 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 14.55 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 15.61 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 16.20 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
17 participants
n=5 Participants
|
62 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
21 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
45 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Study days 14-38Population: Clinically evaluable patients were those that had a diagnosis of CAP, as defined in the inclusion criteria; who received an appropriate course of therapy; who did not receive any other concomitant antibiotics, and who returned for a TOC visit in the appropriate time frame.
Patients were considered cured if all systemic signs and symptoms of CAP present at screening were improved or resolved and no further antibiotic therapy was necessary. In addition, the follow-up chest X-ray was to be either stable or improved.
Outcome measures
| Measure |
Radezolid 300 mg PO Daily (QD)
n=37 Participants
|
Radezolid 450 mg PO Daily (QD)
n=44 Participants
|
Radezolid 450 mg PO Twice Daily (BID)
n=41 Participants
|
|---|---|---|---|
|
Clinical Cure in the Clinically Evaluable (CE) Population at Test of Cure (TOC)
|
34 Participants
|
37 Participants
|
32 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study Days 14-38Population: Microbiologically evaluable (ME) patients were defined as CE patients with evidence of 1 or more of 7 key CAP pathogens: S. pneumoniae, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, and L. pneumophila.
The number of ME patients (defined as those CE patients with evidence of 1 or more of 7 key CAP pathogens: S. pneumoniae, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, and L. pneumophila) with a microbiologic response of eradicated, i.e. either documented eradication of the baseline pathogen(s), or presumed eradication in the setting of clinical cure with no material to culture.
Outcome measures
| Measure |
Radezolid 300 mg PO Daily (QD)
n=17 Participants
|
Radezolid 450 mg PO Daily (QD)
n=26 Participants
|
Radezolid 450 mg PO Twice Daily (BID)
n=26 Participants
|
|---|---|---|---|
|
Per Patient Microbiological Response of Eradicated in the Microbiologically Evaluable (ME) Population at Test of Cure (TOC)
|
16 Participants
|
20 Participants
|
18 Participants
|
Adverse Events
Radezolid 300 mg PO Daily (QD)
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Radezolid 450 mg PO Daily (QD)
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Radezolid 450 mg PO Twice Daily (BID)
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radezolid 300 mg PO Daily (QD)
n=53 participants at risk
|
Radezolid 450 mg PO Daily (QD)
n=52 participants at risk
|
Radezolid 450 mg PO Twice Daily (BID)
n=53 participants at risk
|
|---|---|---|---|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
1.9%
1/52 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the lung
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/52 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/52 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Psychiatric disorders
Confusional state
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/52 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Metabolism and nutrition disorders
Dehyrdation
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/52 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/52 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Investigations
Hepatic enzyme abnormal
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/52 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/52 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
1.9%
1/52 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/52 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/52 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/52 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/52 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
Other adverse events
| Measure |
Radezolid 300 mg PO Daily (QD)
n=53 participants at risk
|
Radezolid 450 mg PO Daily (QD)
n=52 participants at risk
|
Radezolid 450 mg PO Twice Daily (BID)
n=53 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
11.3%
6/53 • Number of events 6 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
19.2%
10/52 • Number of events 10 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
35.8%
19/53 • Number of events 19 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
1.9%
1/52 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
5.7%
3/53 • Number of events 3 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Infections and infestations
Fungal infection
|
5.7%
3/53 • Number of events 3 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
0.00%
0/52 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
3.8%
2/53 • Number of events 2 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Nervous system disorders
Headache
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
5.8%
3/52 • Number of events 3 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
3.8%
2/53 • Number of events 2 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
|
Infections and infestations
Pneumonia
|
1.9%
1/53 • Number of events 1 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
5.8%
3/52 • Number of events 3 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
3.8%
2/53 • Number of events 2 • All adverse events (AEs) were to be reported from the signing of the informed consent until the test of cure (TOC) visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor retains publication rights.
- Publication restrictions are in place
Restriction type: OTHER