Respiratory Tract Infections
Conditions
Keywords
Compliance and Safety Study in Children with Upper and Lower Respiratory Tract Infections
Brief summary
The objective of this study was to obtain data on the safety, tolerability and compliance with Zithromax in children with bacterial infections of the upper and lower respiratory tract.
Detailed description
Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.
Interventions
DRUGAzithromycin
Zithromax was dispensed according to the Summary of Product Characteristics (SPC) as either a tablet or suspension. Zithromax was administered as a total dose of 30 mg/kg which was given as single daily doses of 10 mg/kg for 3 days, or as a 5 day dose starting with 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5.
Sponsors
Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Patients with respiratory tract infections that received azithromycin according to the approved SPC as this was a non-interventional study.
Exclusion criteria
* According to the approved Summary of Product Characteristics (SPC) for Azithromycin as this was a non interventional study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events (AEs) | 3 to 7 days after receiving treatment | All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Withdrew From the Study | 3 to 7 days after receiving treatment | — |
| Compliance | 3 to 7 days after receiving treatment | 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). |
| Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital | Day 1 | Time of exam completion minus the start time of the examination. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 390 |
| Total | 390 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Other | 3 |
| Overall Study | Randomized But Did Not Receive Treatment | 10 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Azithromycin |
|---|---|
| Age, Customized > 12 years to 18 years | 10 participants |
| Age, Customized > 18 years | 0 participants |
| Age, Customized > 1 month to 2 years | 82 participants |
| Age, Customized > 2 years to 12 years | 292 participants |
| Age, Customized Birth to 1 month | 2 participants |
| Age, Customized Unspecified | 4 participants |
| Sex: Female, Male Female | 167 Participants |
| Sex: Female, Male Male | 223 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 390 |
| serious Total, serious adverse events | 0 / 390 |
Outcome results
Primary
Number of Patients With Adverse Events (AEs)
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin | Number of Patients With Adverse Events (AEs) | 27 participants |
Secondary
Compliance
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).
Time frame: 3 to 7 days after receiving treatment
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin | Compliance | Question 1: NA | 6 participants |
| Azithromycin | Compliance | Question 1: Missing | 1 participants |
| Azithromycin | Compliance | Question 1: Yes | 370 participants |
| Azithromycin | Compliance | Question 1: No | 13 participants |
| Azithromycin | Compliance | Question 2: Yes | 374 participants |
| Azithromycin | Compliance | Question 2: No | 9 participants |
| Azithromycin | Compliance | Question 2: NA | 6 participants |
| Azithromycin | Compliance | Question 2: Missing | 1 participants |
| Azithromycin | Compliance | Question 3: Yes | 356 participants |
| Azithromycin | Compliance | Question 3: No | 22 participants |
| Azithromycin | Compliance | Question 3: NA | 11 participants |
| Azithromycin | Compliance | Question 3: Missing | 1 participants |
Secondary
Number of Subjects Who Withdrew From the Study
Time frame: 3 to 7 days after receiving treatment
Population: Safety Population. Please refer to the participant flow and AE sections for results pertaining to tolerability.
Secondary
Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital
Time of exam completion minus the start time of the examination.
Time frame: Day 1
Population: Safety population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Azithromycin | Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital | 20 minutes |