Trial Outcomes & Findings for Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections (NCT NCT00939185)

NCT ID: NCT00939185

Last Updated: 2010-03-30

Results Overview

All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.

• Recruitment status: COMPLETED
• Target enrollment: 400 participants
• Primary outcome timeframe: 3 to 7 days after receiving treatment
• Results posted on: 2010-03-30

Participant Flow

Participant milestones

Measure	Azithromycin The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
Overall Study STARTED	400
Overall Study Received Treatment	390
Overall Study COMPLETED	375
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Measure	Azithromycin The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
Overall Study Adverse Event	3
Overall Study Lack of Efficacy	1
Overall Study Lost to Follow-up	6
Overall Study Other	3
Overall Study Withdrawal by Subject	2
Overall Study Randomized But Did Not Receive Treatment	10

Baseline Characteristics

Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections

Baseline characteristics by cohort

Measure	Azithromycin n=390 Participants The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
Age, Customized Birth to 1 month	2 participants n=5 Participants
Age, Customized > 1 month to 2 years	82 participants n=5 Participants
Age, Customized > 2 years to 12 years	292 participants n=5 Participants
Age, Customized > 12 years to 18 years	10 participants n=5 Participants
Age, Customized > 18 years	0 participants n=5 Participants
Age, Customized Unspecified	4 participants n=5 Participants
Sex: Female, Male Female	167 Participants n=5 Participants
Sex: Female, Male Male	223 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 to 7 days after receiving treatment

Population: Safety population = Those subjects who were known to have received at least one dose of the study treatment. Subjects who were dispensed study treatment and immediately lost to follow-up were not included among those known to have been dosed.

All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.

Outcome measures

Measure

Azithromycin n=390 Participants The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.

Number of Patients With Adverse Events (AEs)

27 participants

SECONDARY outcome

Timeframe: 3 to 7 days after receiving treatment

Population: Safety Population. Please refer to the participant flow and AE sections for results pertaining to tolerability.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 to 7 days after receiving treatment

Population: Safety population

Compliance was assessed by the following questions: Question 1: "Were the pediatrician's instructions during the treatment phase followed (i.e. dose, frequency and number of days)?"; Question 2: "Was it easy to understand your pediatrician's instructions regarding treatment?"; and Question 3: "Was the administration of this drug easier than any other previously used drug?" Patients could answer either "yes", "no", or "Not applicable (NA)".

Outcome measures

Measure	Azithromycin n=390 Participants The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
Compliance Question 1: Yes	370 participants
Compliance Question 1: No	13 participants
Compliance Question 1: NA	6 participants
Compliance Question 1: Missing	1 participants
Compliance Question 2: Yes	374 participants
Compliance Question 2: No	9 participants
Compliance Question 2: NA	6 participants
Compliance Question 3: Yes	356 participants
Compliance Question 3: No	22 participants
Compliance Question 3: NA	11 participants
Compliance Question 3: Missing	1 participants
Compliance Question 2: Missing	1 participants

SECONDARY outcome

Timeframe: Day 1

Population: Safety population

Time of exam completion minus the start time of the examination.

Outcome measures

Measure

Azithromycin n=398 Participants The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.

Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital

20 minutes Interval 5.0 to 585.0

Adverse Events

Azithromycin

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Azithromycin n=390 participants at risk The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
Gastrointestinal disorders Abdominal pain	1.5% 6/390
Gastrointestinal disorders Abdominal pain upper	0.26% 1/390
Gastrointestinal disorders Diarrhoea	2.3% 9/390
Gastrointestinal disorders Nausea	0.26% 1/390
Gastrointestinal disorders Vomiting	1.5% 6/390
General disorders Chest pain	0.26% 1/390
Infections and infestations Gastroenteritis	0.26% 1/390
Psychiatric disorders Anxiety	0.51% 2/390
Respiratory, thoracic and mediastinal disorders Diaphragmalgia	0.26% 1/390
Skin and subcutaneous tissue disorders Angioedema	0.26% 1/390
Skin and subcutaneous tissue disorders Rash	0.51% 2/390
Skin and subcutaneous tissue disorders Urticaria	0.26% 1/390

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.govCallCenter@pfizer.com

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