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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events (AEs) | All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported. | 3 to 7 days after receiving treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Withdrew From the Study | 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)". |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | 3 to 7 days after receiving treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
Only 1 subject received tablet; therefore, no suspension versus tablet efficacy data is displayed as initially planned.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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|
|
| 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. | Day 1 |
| Other |
|
| Withdrawal by Subject |
|
| Randomized But Did Not Receive Treatment |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Subjects Who Withdrew From the Study | Safety Population. Please refer to the participant flow and AE sections for results pertaining to tolerability. | Posted | Number | participants | 3 to 7 days after receiving treatment |
|
|
| 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)". | Safety population | Posted | Number | participants | 3 to 7 days after receiving treatment |
|
|
|
| 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. | Safety population | Posted | Median | Full Range | minutes | Day 1 |
|
|
|
| 0 |
| 390 |
| 27 |
| 390 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Diaphragmalgia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
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.
| D015438 | Health Behavior |
| D001519 | Behavior |
| Organic Chemicals |
| Title | Measurements |
|---|---|
|
| Question 1: Missing |
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| Question 2: Yes |
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| Question 2: No |
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| Question 2: NA |
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| Question 2: Missing |
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| Question 3: Yes |
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| Question 3: No |
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| Question 3: NA |
|
| Question 3: Missing |
|