Trial Outcomes & Findings for Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children (NCT NCT02707523)
NCT ID: NCT02707523
Last Updated: 2020-07-22
Results Overview
To determine the safety profile of AZM at 10 mg/kg and 20 mg/kg IV X 3 days in children with RSV-induced respiratory failure
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline through Day 3
Results posted on
2020-07-22
Participant Flow
Participant milestones
| Measure |
Control
Placebo controlled (normal saline) daily for 3 days
|
Azithromycin (10 mg/kg)
10 mg/kg IV Azithromycin daily for 3 days
|
Azithromycin (20 mg/kg)
20 mg/kg IV Azithromycin daily for 3 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children
Baseline characteristics by cohort
| Measure |
Control
n=16 Participants
Placebo controlled (normal saline) daily for 3 days
|
Azithromycin (10 mg/kg)
n=16 Participants
10 mg/kg IV Azithromycin daily for 3 days
|
Azithromycin (20 mg/kg)
n=16 Participants
20 mg/kg IV Azithromycin daily for 3 days
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
10.8 months
STANDARD_DEVIATION 11 • n=5 Participants
|
21.6 months
STANDARD_DEVIATION 29 • n=7 Participants
|
20.2 months
STANDARD_DEVIATION 23 • n=5 Participants
|
17.5 months
STANDARD_DEVIATION 23 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 3To determine the safety profile of AZM at 10 mg/kg and 20 mg/kg IV X 3 days in children with RSV-induced respiratory failure
Outcome measures
| Measure |
Control
n=16 Participants
Placebo controlled (normal saline) daily for 3 days
Placebo
|
Azithromycin (10 mg/kg)
n=16 Participants
10 mg/kg IV Azithromycin daily for 3 days
Azithromycin 10 mg
|
Azithromycin (20 mg/kg)
n=16 Participants
20 mg/kg IV Azithromycin daily for 3 days
Azithromycin 20mg
|
|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 3To determine the concentration of total MMP-9 levels in the nasal compartment
Outcome measures
| Measure |
Control
n=16 Participants
Placebo controlled (normal saline) daily for 3 days
Placebo
|
Azithromycin (10 mg/kg)
n=16 Participants
10 mg/kg IV Azithromycin daily for 3 days
Azithromycin 10 mg
|
Azithromycin (20 mg/kg)
n=16 Participants
20 mg/kg IV Azithromycin daily for 3 days
Azithromycin 20mg
|
|---|---|---|---|
|
Nasal Total Matrix Metalloproteinase (MMP)-9 Level
|
545 ng/ml
Standard Deviation 708
|
267 ng/ml
Standard Deviation 301
|
413 ng/ml
Standard Deviation 814
|
PRIMARY outcome
Timeframe: From baseline to 72 hours post treatmentMeasurement of AZM half life in the plasma
Outcome measures
| Measure |
Control
n=16 Participants
Placebo controlled (normal saline) daily for 3 days
Placebo
|
Azithromycin (10 mg/kg)
n=16 Participants
10 mg/kg IV Azithromycin daily for 3 days
Azithromycin 10 mg
|
Azithromycin (20 mg/kg)
n=16 Participants
20 mg/kg IV Azithromycin daily for 3 days
Azithromycin 20mg
|
|---|---|---|---|
|
Pharmacokinetic-Plasma Half Life of AZM
|
0 hours
Standard Deviation 0
|
76 hours
Standard Deviation 17
|
102 hours
Standard Deviation 33
|
PRIMARY outcome
Timeframe: From baseline to 72 hours post treatmentMeasurement of AZM half life in the lung
Outcome measures
| Measure |
Control
n=16 Participants
Placebo controlled (normal saline) daily for 3 days
Placebo
|
Azithromycin (10 mg/kg)
n=16 Participants
10 mg/kg IV Azithromycin daily for 3 days
Azithromycin 10 mg
|
Azithromycin (20 mg/kg)
n=16 Participants
20 mg/kg IV Azithromycin daily for 3 days
Azithromycin 20mg
|
|---|---|---|---|
|
Pharmacokinetic-Lung Half Life of AZM
|
0 hours
Standard Deviation 0
|
78 hours
Standard Deviation 31
|
385 hours
Standard Deviation 63
|
SECONDARY outcome
Timeframe: Pre-treatment through 2 weeksDuration of mechanical ventilation in days for enrolled subjects
Outcome measures
| Measure |
Control
n=16 Participants
Placebo controlled (normal saline) daily for 3 days
Placebo
|
Azithromycin (10 mg/kg)
n=16 Participants
10 mg/kg IV Azithromycin daily for 3 days
Azithromycin 10 mg
|
Azithromycin (20 mg/kg)
n=16 Participants
20 mg/kg IV Azithromycin daily for 3 days
Azithromycin 20mg
|
|---|---|---|---|
|
Duration of Mechanical Ventilation in Days
|
4.8 Days
Standard Deviation 3.4
|
5.6 Days
Standard Deviation 5.5
|
2.6 Days
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Pre-treatment through 2 weeksDuration of BiPAP in days for enrolled subjects
Outcome measures
| Measure |
Control
n=16 Participants
Placebo controlled (normal saline) daily for 3 days
Placebo
|
Azithromycin (10 mg/kg)
n=16 Participants
10 mg/kg IV Azithromycin daily for 3 days
Azithromycin 10 mg
|
Azithromycin (20 mg/kg)
n=16 Participants
20 mg/kg IV Azithromycin daily for 3 days
Azithromycin 20mg
|
|---|---|---|---|
|
Duration of BiPAP in Days
|
3.6 days
Standard Deviation 13.2
|
0.4 days
Standard Deviation 1.5
|
0.1 days
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Pre-treatment through 2 weeksDuration of High Flow Nasal Cannula in days for enrolled subjects
Outcome measures
| Measure |
Control
n=16 Participants
Placebo controlled (normal saline) daily for 3 days
Placebo
|
Azithromycin (10 mg/kg)
n=16 Participants
10 mg/kg IV Azithromycin daily for 3 days
Azithromycin 10 mg
|
Azithromycin (20 mg/kg)
n=16 Participants
20 mg/kg IV Azithromycin daily for 3 days
Azithromycin 20mg
|
|---|---|---|---|
|
Duration of High Flow Nasal Cannula in Days
|
3.3 Days
Standard Deviation 4.9
|
2.4 Days
Standard Deviation 2
|
2.3 Days
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Pre-treatment through 2 weeksDuration of oxygenation in days for enrolled subjects
Outcome measures
| Measure |
Control
n=16 Participants
Placebo controlled (normal saline) daily for 3 days
Placebo
|
Azithromycin (10 mg/kg)
n=16 Participants
10 mg/kg IV Azithromycin daily for 3 days
Azithromycin 10 mg
|
Azithromycin (20 mg/kg)
n=16 Participants
20 mg/kg IV Azithromycin daily for 3 days
Azithromycin 20mg
|
|---|---|---|---|
|
Duration of Oxygenation in Days
|
11 days
Standard Deviation 8.7
|
9.6 days
Standard Deviation 5.8
|
6.6 days
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Pre-treatment through 2 weeksDuration of hospitalization in days for enrolled subjects
Outcome measures
| Measure |
Control
n=16 Participants
Placebo controlled (normal saline) daily for 3 days
Placebo
|
Azithromycin (10 mg/kg)
n=16 Participants
10 mg/kg IV Azithromycin daily for 3 days
Azithromycin 10 mg
|
Azithromycin (20 mg/kg)
n=16 Participants
20 mg/kg IV Azithromycin daily for 3 days
Azithromycin 20mg
|
|---|---|---|---|
|
Duration of Hospitalization in Days
|
15.8 days
Standard Deviation 13.1
|
11.8 days
Standard Deviation 6.5
|
9.1 days
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Pre-treatment through 2 weeksDuration of PICU stay in days for enrolled subjects
Outcome measures
| Measure |
Control
n=16 Participants
Placebo controlled (normal saline) daily for 3 days
Placebo
|
Azithromycin (10 mg/kg)
n=16 Participants
10 mg/kg IV Azithromycin daily for 3 days
Azithromycin 10 mg
|
Azithromycin (20 mg/kg)
n=16 Participants
20 mg/kg IV Azithromycin daily for 3 days
Azithromycin 20mg
|
|---|---|---|---|
|
Duration of PICU Stay in Days
|
7.7 days
Standard Deviation 4.4
|
8.1 days
Standard Deviation 5.8
|
5.4 days
Standard Deviation 2.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3To determine the concentration of MMP-9 levels in the lung compartment
Outcome measures
| Measure |
Control
n=16 Participants
Placebo controlled (normal saline) daily for 3 days
Placebo
|
Azithromycin (10 mg/kg)
n=16 Participants
10 mg/kg IV Azithromycin daily for 3 days
Azithromycin 10 mg
|
Azithromycin (20 mg/kg)
n=16 Participants
20 mg/kg IV Azithromycin daily for 3 days
Azithromycin 20mg
|
|---|---|---|---|
|
Lung Matrix Metalloproteinase (MMP) Level
|
13743 ng/ml
Standard Deviation 23831
|
1448 ng/ml
Standard Deviation 1478
|
1908 ng/ml
Standard Deviation 2588
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Azithromycin (10 mg/kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Azithromycin (20 mg/kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place