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Trial Outcomes & Findings for Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates (NCT NCT00599053)

NCT ID: NCT00599053

Last Updated: 2017-05-17

Results Overview

Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

7 participants

Primary outcome timeframe

100 days or discharge from hospital

Results posted on

2017-05-17

Participant Flow

Participant milestones

Participant milestones
Measure
Early Treatment With Azithromycin
Azithromycin (10mg/kg/day) start \< 72 hours of age for 10 days
Expectant (Usual) Management
Intervention at the discretion of the attending physician
Overall Study
STARTED
5
2
Overall Study
COMPLETED
5
2
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Early Treatment With Azithromycin
n=5 Participants
Azithromycin (10mg/kg/day) start \< 72 hours of age for 10 days
Expectant (Usual) Management
n=2 Participants
Intervention at the discretion of the attending physician
Total
n=7 Participants
Total of all reporting groups
Age, Categorical
<=18 years
5 Participants
n=5 Participants
2 Participants
n=7 Participants
7 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
Sex: Female, Male
Female
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Region of Enrollment
United States
5 participants
n=5 Participants
2 participants
n=7 Participants
7 participants
n=5 Participants

PRIMARY outcome

Timeframe: 100 days or discharge from hospital

Population: Unable to determine efficacy due to low enrollment

Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 100 days or discharge from hospital

Population: Unable to determine Pharmacokinetics (PK) data due to low enrollment

Pharmacokinetic measures (AUC12) of subjects receiving azithromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: from day 1 of study drug through 100 days or discharge from hospital, which ever comes first

Number of serious of adverse event experienced by subjects treated with azithromycin

Outcome measures

Outcome measures
Measure
Early Treatment With Azithromycin
n=5 Participants
Azithromycin (10mg/kg/day) start \< 72 hours of age for 10 days
Expectant (Usual) Management
n=2 Participants
Intervention at the discretion of the attending physician
Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
0 number of events
Interval 0.0 to 0.0
0 number of events
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: from baseline to 100 days or discharge from Hospital, which ever comes first

Absence of Ureaplasma spp infection is determined by the total number of days with positive pressure ventilation, (conventional ventilation or nasal continuous positive pressure) and oxygen therapy. The mean number of days was used to compare the two treatment groups.

Outcome measures

Outcome measures
Measure
Early Treatment With Azithromycin
n=5 Participants
Azithromycin (10mg/kg/day) start \< 72 hours of age for 10 days
Expectant (Usual) Management
n=2 Participants
Intervention at the discretion of the attending physician
Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups
09.4 days
Interval 0.0 to 23.0
2.5 days
Interval 0.0 to 5.0

Adverse Events

Early Treatment With Azithromycin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Expectant (Usual) Management

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

Dr. David Randolph

University of Alabama at Birmingham

Phone: 205-934-4680

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place