Trial Outcomes & Findings for Trial II of Lung Protection With Azithromycin in the Preterm Infant (NCT NCT00319956)

Results Overview

comparison of the % Incidence of bronchopulmonary dysplasia (BPD) for the azithromycin vs placebo groups.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

220 participants

Primary outcome timeframe

diagnosis of BPD at 36wks corrected gestational age

Results posted on

2018-06-27

Participant Flow

The study recruitment started 9/04 ended 8/08. All subjects were enrolled after admission to NICU. Randomized treatment started within 12 hrs of beginning ventilatory support. If outborn, consent was obtained from parent(s) after phone discussion by the research staff. The consents were faxed, witnessed and brought back by the Transport Team.

Participant milestones

Participant milestones
Measure	Azith Group Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.	Placebo Group D5W : Dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
Overall Study STARTED	111	109
Overall Study COMPLETED	91	85
Overall Study NOT COMPLETED	20	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Azith Group Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.	Placebo Group D5W : Dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
Overall Study Death	20	24

Baseline Characteristics

Trial II of Lung Protection With Azithromycin in the Preterm Infant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azith Group n=111 Participants Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.	Placebo Group n=109 Participants D5W : Dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.	Total n=220 Participants Total of all reporting groups
Age, Categorical <=18 years	111 Participants n=5 Participants	109 Participants n=7 Participants	220 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	25.7 gestational age, weeks STANDARD_DEVIATION 1.5 • n=5 Participants	26 gestational age, weeks STANDARD_DEVIATION 1.6 • n=7 Participants	25.85 gestational age, weeks STANDARD_DEVIATION 1.55 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	59 Participants n=7 Participants	108 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	50 Participants n=7 Participants	112 Participants n=5 Participants
Region of Enrollment United States	111 participants n=5 Participants	109 participants n=7 Participants	220 participants n=5 Participants

PRIMARY outcome

Timeframe: diagnosis of BPD at 36wks corrected gestational age

Population: Mortality was 18% in the Azithromycin group and 22% in the Placebo group, thus 91 participants in the Azithromycin group and 85 participants in the Placebo group were analyzed.

comparison of the % Incidence of bronchopulmonary dysplasia (BPD) for the azithromycin vs placebo groups.

Outcome measures

Outcome measures
Measure	Azith Group n=91 Participants Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.	Placebo Group n=85 Participants D5W : Dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
Incidence of Bronchopulmonary Dysplasia (BPD)	76 percentage w/ BPD	84 percentage w/ BPD

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks

Steroids will be provided as needed based on Standard of Care. Data are presented as the percent of participants that received steroids between birth and discharge from the NICU.

Outcome measures

Outcome measures
Measure	Azith Group n=111 Participants Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.	Placebo Group n=109 Participants D5W : Dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
Postnatal Steroid Use	18 percentage of participants	22 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks

Participants will be placed on mechanical ventilation as necessary based on standard of care. Data are presented as the percent of participants in each group receiving mechanical ventilation.

Outcome measures

Outcome measures
Measure	Azith Group n=111 Participants Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.	Placebo Group n=109 Participants D5W : Dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
Number of Days on Mechanical Ventilation	28 days Standard Deviation 26	26 days Standard Deviation 26

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks

Data will be collected on the number of participants that did not survive to discharge from the NICU. Data are presented as the percent of participants that did not survive.

Outcome measures

Outcome measures
Measure	Azith Group n=111 Participants Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.	Placebo Group n=109 Participants D5W : Dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
Participant Mortality	18 percentage of mortality	22 percentage of mortality

Adverse Events

Azith Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 20 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 24 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hubert O. Ballard

University of Kentucky Medical Center

Phone: 859-323-1496

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place