An observational study in Respiratory Tract Infections, sponsored by Pfizer. Completed. Open to participants aged 1 Year to 14 Years. Per ClinicalTrials.gov, last updated 2010-03-30.
Sponsored by Pfizer · Observational
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.
Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.
1,052 studies on the registry are indexed under Respiratory Tract Infections; 147 are open to participants now.
This study's enrollment of 400 is above the median of 300 across 299 observational studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
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ZITHROMAX® administration will be considered in children / adolescents from the first year of life up to 14 years old with the following diagnoses: Acute otitis media, Sinusitis, Pharyngitis/tonsillitis, Pneumonia, Bronchitis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Azithromycin
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.
Also known as: Zithromax
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
Number of Subjects Who Withdrew From the Study
Time frame: 3 to 7 days after receiving treatment
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
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
| Milestone | Azithromycin |
|---|---|
| Started | 400 |
| Received treatment | 390 |
| Completed | 375 |
| Not completed | 25 |
| Withdrew: Adverse event | 3 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Other | 3 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Randomized but did not receive treatment | 10 |
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.
| participants | Azithromycin |
|---|---|
| Number of Patients With Adverse Events (AEs) | 27 |
No measurements were reported for this outcome.
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)".
| participants | Azithromycin |
|---|---|
| Question 1: Yes | 370 |
| Question 1: No | 13 |
| Question 1: NA | 6 |
| Question 1: Missing | 1 |
| Question 2: Yes | 374 |
| Question 2: No | 9 |
| Question 2: NA | 6 |
| Question 2: Missing | 1 |
| Question 3: Yes | 356 |
| Question 3: No | 22 |
| Question 3: NA | 11 |
| Question 3: Missing | 1 |
Time of exam completion minus the start time of the examination.
| minutes | Azithromycin |
|---|---|
| Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital | 20 (5 to 585) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Azithromycin | — | 0/390 (0%) | 27/390 (6.9%) |
| Event | Azithromycin |
|---|---|
| DiarrhoeaGastrointestinal disorders | 9/390 |
| Abdominal painGastrointestinal disorders | 6/390 |
| VomitingGastrointestinal disorders | 6/390 |
| AnxietyPsychiatric disorders | 2/390 |
| RashSkin and subcutaneous tissue disorders | 2/390 |
| Abdominal pain upperGastrointestinal disorders | 1/390 |
| NauseaGastrointestinal disorders | 1/390 |
| Chest painGeneral disorders | 1/390 |
| GastroenteritisInfections and infestations | 1/390 |
| DiaphragmalgiaRespiratory, thoracic and mediastinal disorders | 1/390 |
| Age, Customized(participants) | Azithromycin |
|---|---|
| Birth to 1 month | 2 |
| > 1 month to 2 years | 82 |
| > 2 years to 12 years | 292 |
| > 12 years to 18 years | 10 |
| > 18 years | 0 |
| Unspecified | 4 |
| Sex: Female, Male(Participants) | Azithromycin |
|---|---|
| Female | 167 |
| Male | 223 |
No study locations are listed for this record.
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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