Trial Outcomes & Findings for Phase II Study of Oral Nafithromycin in CABP (NCT NCT02903836)
NCT ID: NCT02903836
Last Updated: 2019-12-20
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
231 participants
Primary outcome timeframe
Day 4 from start of drug administration
Results posted on
2019-12-20
Participant Flow
2 subjects withdrew consent prior to receiving study drug and 7 subjects whose PK results showed no detectable level of either nafithromycin or moxifloxacin hence 9 subjects excluded from the Safety population.
Participant milestones
| Measure |
Nafithromycin 800 mg 3 Days
PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind
Nafithromycin 800 mg 3 days
|
Nafithromycin 800 mg 5 Days
PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind
Nafithromycin 800 mg 5 days
|
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
Moxifloxacin 400 mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
74
|
73
|
77
|
|
Overall Study
COMPLETED
|
71
|
69
|
73
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Oral Nafithromycin in CABP
Baseline characteristics by cohort
| Measure |
Nafithromycin 800 mg 3 Days
n=74 Participants
PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind
Nafithromycin 800 mg 3 days
|
Nafithromycin 800 mg 5 Days
n=73 Participants
PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind
Nafithromycin 800 mg 5 days
|
Moxifloxacin 400 mg 7 Days
n=77 Participants
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
Moxifloxacin 400 mg 7 days
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.00 Years
STANDARD_DEVIATION 15.73 • n=5 Participants
|
54.90 Years
STANDARD_DEVIATION 16.90 • n=7 Participants
|
56.10 Years
STANDARD_DEVIATION 15.18 • n=5 Participants
|
56.00 Years
STANDARD_DEVIATION 15.89 • n=4 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Region of Enrollment
Georgia
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Region of Enrollment
Latvia
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 4 from start of drug administrationThe 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
Outcome measures
| Measure |
Nafithromycin 800 mg 3 Days
n=74 Participants
PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind
Nafithromycin 800 mg 3 days
|
Nafithromycin 800 mg 5 Days
n=73 Participants
PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind
Nafithromycin 800 mg 5 days
|
Moxifloxacin 400 mg
n=77 Participants
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
Moxifloxacin 400 mg
|
|---|---|---|---|
|
Clinical Response in the ITT Population
|
68 Participants
|
65 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: Day 4 from start of drug administrationPopulation: The micro-ITT population included all ITT subjects who had at least one baseline Gram-positive or atypical bacterial pathogen known to cause CABP.
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
Outcome measures
| Measure |
Nafithromycin 800 mg 3 Days
n=22 Participants
PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind
Nafithromycin 800 mg 3 days
|
Nafithromycin 800 mg 5 Days
n=27 Participants
PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind
Nafithromycin 800 mg 5 days
|
Moxifloxacin 400 mg
n=20 Participants
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
Moxifloxacin 400 mg
|
|---|---|---|---|
|
Clinical Response in the Micro-ITT Population
|
21 Participants
|
26 Participants
|
18 Participants
|
Adverse Events
Nafithromycin 800 mg 3 Days
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Nafithromycin 800 mg 5 Days
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Moxifloxacin 400 mg 7 Days
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Nafithromycin 800 mg 3 Days
n=74 participants at risk
PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind
Nafithromycin 800 mg 3 days
|
Nafithromycin 800 mg 5 Days
n=72 participants at risk
PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind
Nafithromycin 800 mg 5 days
|
Moxifloxacin 400 mg 7 Days
n=76 participants at risk
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
Moxifloxacin 400 mg 7 days
|
|---|---|---|---|
|
Nervous system disorders
Ischemic Stroke
|
0.00%
0/74 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
0.00%
0/72 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
1.3%
1/76 • Number of events 1 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/74 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
0.00%
0/72 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
1.3%
1/76 • Number of events 1 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/74 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
1.4%
1/72 • Number of events 1 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
0.00%
0/76 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/74 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
0.00%
0/72 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
1.3%
1/76 • Number of events 1 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
|
Cardiac disorders
Cor pulmonale
|
1.4%
1/74 • Number of events 1 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
0.00%
0/72 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
0.00%
0/76 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
1.4%
1/74 • Number of events 1 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
0.00%
0/72 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
0.00%
0/76 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
Other adverse events
| Measure |
Nafithromycin 800 mg 3 Days
n=74 participants at risk
PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind
Nafithromycin 800 mg 3 days
|
Nafithromycin 800 mg 5 Days
n=72 participants at risk
PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind
Nafithromycin 800 mg 5 days
|
Moxifloxacin 400 mg 7 Days
n=76 participants at risk
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
Moxifloxacin 400 mg 7 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
4.1%
3/74 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
1.4%
1/72 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
0.00%
0/76 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
|
Gastrointestinal disorders
Nausea
|
4.1%
3/74 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
6.9%
5/72 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
2.6%
2/76 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
2/74 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
2.8%
2/72 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
3.9%
3/76 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
|
Vascular disorders
Hypertension
|
4.1%
3/74 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
1.4%
1/72 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
2.6%
2/76 • From signing of Informed Consent Form to Follow up Visit (Day 31)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER