Trial Outcomes & Findings for Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media (NCT NCT00796224)

NCT ID: NCT00796224

Last Updated: 2010-02-18

Results Overview

AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Predose/0 to 72 Hours

Results posted on

2010-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	60 mg/kg Azithromycin Extended-release (ER) Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.	30 mg/kg Azithromycin Immediate-release (IR) Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.
Overall Study STARTED	19	19
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	60 mg/kg Azithromycin Extended-release (ER) Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.	30 mg/kg Azithromycin Immediate-release (IR) Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.
Overall Study Adverse Event	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	60 mg/kg Azithromycin ER n=19 Participants Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.	30 mg/kg Azithromycin IR n=19 Participants Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.	Total n=38 Participants Total of all reporting groups
Age, Customized 1 month to <2 years	13 participants n=5 Participants	6 participants n=7 Participants	19 participants n=5 Participants
Age, Customized 2 years to <12 years	6 participants n=5 Participants	13 participants n=7 Participants	19 participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose/0 to 72 Hours

Population: All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.

AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.

Outcome measures

Outcome measures
Measure	60 mg/kg Azithromycin ER n=18 Participants	30 mg/kg Azithromycin IR n=18 Participants
Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)	12173.023 ng*hr/ml Standard Deviation 6305.0325	7950.949 ng*hr/ml Standard Deviation 4759.3010

SECONDARY outcome

Timeframe: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose

Population: All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.

AUCinf = AUClast + (Clast\* divided by kel), where AUClast is calculated by Linear-Log trapezoidal method, Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Outcome measures

Outcome measures
Measure	60 mg/kg Azithromycin ER n=18 Participants	30 mg/kg Azithromycin IR n=18 Participants
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)	15536.196 ng*hr/ml Standard Deviation 9310.3993	9645.630 ng*hr/ml Standard Deviation 6062.6789

SECONDARY outcome

Timeframe: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose

Population: All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.

Outcome measures

Outcome measures
Measure	60 mg/kg Azithromycin ER n=18 Participants	30 mg/kg Azithromycin IR n=18 Participants
Maximum Observed Plasma Concentration (Cmax) of Azithromycin	774.750 ng/ml Standard Deviation 477.9896	901.644 ng/ml Standard Deviation 600.6826

SECONDARY outcome

Timeframe: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose

Population: All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half.

Outcome measures

Outcome measures
Measure	60 mg/kg Azithromycin ER n=18 Participants	30 mg/kg Azithromycin IR n=18 Participants
Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin Tmax	3.0 hr Interval 2.0 to 8.0	2.0 hr Interval 1.0 to 4.0
Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin t1/2	30.303 hr Interval 15.0 to 52.2	28.959 hr Interval 10.4 to 49.0

SECONDARY outcome

Timeframe: 1,2,3,4,8,24,48,72 hours postdose

Population: All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.

Outcome measures

Outcome measures
Measure	60 mg/kg Azithromycin ER n=18 Participants	30 mg/kg Azithromycin IR n=18 Participants
Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) Serum Concentration 1 hour postdose	99.96 ng/ml	152.75 ng/ml
Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) Serum Concentration 2 hour postdose	293.14 ng/ml	579.72 ng/ml
Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) Serum Concentration 3 hour postdose	381.96 ng/ml	381.69 ng/ml
Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) Serum Concentration 4 hour postdose	441.79 ng/ml	267.86 ng/ml
Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) Serum Concentration 8 hour postdose	244.75 ng/ml	140.33 ng/ml
Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) Serum Concentration 24 hour postdose	142.41 ng/ml	82.31 ng/ml
Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) Serum Concentration 48 hour postdose	94.79 ng/ml	50.06 ng/ml
Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) Serum Concentration 72 hour postdose	56.03 ng/ml	30.6 ng/ml

SECONDARY outcome

Timeframe: Days 7,8,9 or 10

Population: Any worsening of existing signs and symptoms, or new signs and symptoms, were documented as adverse events.

Clinical response was assesed between Days 7 and 10, or when subjects discontinued the study prematurely (if applicable). Response was assessed by the investigator as cure or failure. Cure = Clinical signs and symptoms related to the acute illness have resolved, or clinical improvement is such that no additional therapy is necessary. Failure = One or more of the following: * Signs and symptoms related to the acute illness have persisted or worsened and additional therapy is necessary; * New clinical signs and symptoms of acute illness have developed and additional therapy is necessary

Outcome measures

Outcome measures
Measure	60 mg/kg Azithromycin ER n=18 Participants	30 mg/kg Azithromycin IR n=18 Participants
Number of Participants With a Clinical Response Cure	18 participants	16 participants
Number of Participants With a Clinical Response Failure	0 participants	2 participants

SECONDARY outcome

Timeframe: Baseline up to 28 days

Population: All subjects who received at least 1 dose of study medication were included in the safety analyses.

All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported.

Outcome measures

Outcome measures
Measure	60 mg/kg Azithromycin ER n=19 Participants	30 mg/kg Azithromycin IR n=19 Participants
Adverse Events (AEs) and Serious AEs (SAEs) AEs	4 participants	5 participants
Adverse Events (AEs) and Serious AEs (SAEs) SAEs	0 participants	0 participants

Adverse Events

60 mg/kg Azithromycin ER

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

30 mg/kg Azithromycin IR

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	60 mg/kg Azithromycin ER n=19 participants at risk	30 mg/kg Azithromycin IR n=19 participants at risk
Gastrointestinal disorders Diarrhoea	0.00% 0/19	5.3% 1/19
Gastrointestinal disorders Nausea	5.3% 1/19	0.00% 0/19
Gastrointestinal disorders Vomiting	15.8% 3/19	5.3% 1/19
General disorders Treatment failure	0.00% 0/19	10.5% 2/19
Metabolism and nutrition disorders Anorexia	0.00% 0/19	5.3% 1/19

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER