Trial Outcomes & Findings for The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease (NCT NCT02544984)
NCT ID: NCT02544984
Last Updated: 2018-06-06
Results Overview
Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time at the end of the winter season, which accounts for the variability in the amount of time participants were observed.
COMPLETED
NA
60 participants
5 to 8 months
2018-06-06
Participant Flow
Participant milestones
| Measure |
Placebo
The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
|
Azithromycin
The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=30 Participants
The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
|
Azithromycin
n=30 Participants
The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 6 -24 months
|
19 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
|
Age, Customized
Age · 24 months-72 months
|
11 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
60 Participants
n=35 Participants
|
|
Gestational Age
<28 weeks
|
22 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Gestational Age
28-31 weeks
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Gestational Age
32-36 weeks
|
2 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Number of Participants who Received Synagis Injection
|
14 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Number of Patients with Tracheostomy
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 5 to 8 monthsParticipants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time at the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Outcome measures
| Measure |
Placebo
n=30 Participants
The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
|
Azithromycin
n=30 Participants
The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
|
|---|---|---|
|
Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations)
Unscheduled clinic visits for respiratory symptoms
|
16 visits
|
21 visits
|
|
Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations)
Unscheduled clinic visits for other symptoms
|
3 visits
|
5 visits
|
|
Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations)
Emergency room visits
|
15 visits
|
6 visits
|
|
Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations)
Hospital admissions
|
6 visits
|
5 visits
|
SECONDARY outcome
Timeframe: 5 to 8 monthsParticipants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time at the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Outcome measures
| Measure |
Placebo
n=30 Participants
The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
|
Azithromycin
n=30 Participants
The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
|
|---|---|---|
|
Number of Adverse Events
|
4 adverse events
|
2 adverse events
|
SECONDARY outcome
Timeframe: 5 to 8 monthsPopulation: Cost-effective analyses are only justified for interventions that are shown to be effective. Because the intervention at study (the macrolide azithromycin) showed no benefit and led to worse outcomes than those with usual care, an economic evaluation is not warranted and claims data was not collected.
Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsTo determine if prophylactic use of azithromycin will reduce the total number of unscheduled face-to-face physician visit for respiratory related illness in a clinic, urgent care, emergency room or hospital setting during the following 12 months after the intervention.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsTo determine if prophylactic use of azithromycin will reduce level of airway resistance as measured by an Airwave Oscillometry System in subjects above 2 years of age, at the time of respiratory illnesses, during the 3-6 months intervention.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 monthsUsing a standardize nasal wash procedure, respiratory samples will be collected at enrollment, at end of study, and during acute respiratory illness requiring face-to-face provider interaction. Children with a tracheostomy will have both a nasal wash sample and a tracheal aspirate sample collected. The respiratory samples will be stabilized with a universal transport media, processed and stored at -80 C for future testing. Testing will be performed for cytokines/chemokines; other biomarkers of disease such as LDH, MPO, and caspase; viral and bacterial respiratory pathogens; and microbiome.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Azithromycin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=28 participants at risk
The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
|
Azithromycin
n=28 participants at risk
The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
2/28 • Number of events 2 • 5 to 8 months - Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Parents were contacted biweekly, either in clinic or by phone, to monitor for any adverse reactions, including rash, nausea, vomiting, diarrhea, or abdominal cramping.
|
0.00%
0/28 • 5 to 8 months - Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Parents were contacted biweekly, either in clinic or by phone, to monitor for any adverse reactions, including rash, nausea, vomiting, diarrhea, or abdominal cramping.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
2/28 • Number of events 2 • 5 to 8 months - Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Parents were contacted biweekly, either in clinic or by phone, to monitor for any adverse reactions, including rash, nausea, vomiting, diarrhea, or abdominal cramping.
|
3.6%
1/28 • Number of events 1 • 5 to 8 months - Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Parents were contacted biweekly, either in clinic or by phone, to monitor for any adverse reactions, including rash, nausea, vomiting, diarrhea, or abdominal cramping.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/28 • 5 to 8 months - Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Parents were contacted biweekly, either in clinic or by phone, to monitor for any adverse reactions, including rash, nausea, vomiting, diarrhea, or abdominal cramping.
|
3.6%
1/28 • Number of events 1 • 5 to 8 months - Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.
Parents were contacted biweekly, either in clinic or by phone, to monitor for any adverse reactions, including rash, nausea, vomiting, diarrhea, or abdominal cramping.
|
Additional Information
Ricardo A. Mosquera, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place