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The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. | Active Comparator | 60 mg/kg azithromycin ER (Extended Release)arm |
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| 2. | Active Comparator | 30 mg/kg azithromycin IR (Immediate Release) arm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 60 mg/kg azithromycin ER | Drug | subjects taken 60 mg/kg azithromycin ER |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) | AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours. | Predose/0 to 72 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | San José | Provincia de San José | 0000 | Costa Rica | ||
| Pfizer Investigational Site |
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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 | 60 mg/kg Azithromycin Extended-release (ER) | Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1. |
| FG001 | 30 mg/kg Azithromycin Immediate-release (IR) | Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 60 mg/kg Azithromycin ER | Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1. |
| BG001 | 30 mg/kg Azithromycin IR | Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) | AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours. | All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest. | Posted | Mean | Standard Deviation | ng*hr/ml | Predose/0 to 72 Hours |
|
|
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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 | 60 mg/kg Azithromycin ER |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
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| 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 |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| 30 mg/kg azithromycin IR | Drug | subjects taken 30 mg/kg azithromycin IR (Immediate Release) |
|
|
| Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) of Azithromycin | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin | Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half. | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose |
| Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) | 1,2,3,4,8,24,48,72 hours postdose |
| Number of Participants With a Clinical Response | 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:
| Days 7,8,9 or 10 |
| Adverse Events (AEs) and Serious AEs (SAEs) | All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported. | Baseline up to 28 days |
| San José |
| Provincia de San José |
| Costa Rica |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) | 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. | All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest. | Posted | Mean | Standard Deviation | ng*hr/ml | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Azithromycin | All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest. | Posted | Mean | Standard Deviation | ng/ml | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose |
|
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin | Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half. | All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest. | Posted | Median | Full Range | hr | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose |
|
|
|
| Secondary | Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) | All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest. | Posted | Number | ng/ml | 1,2,3,4,8,24,48,72 hours postdose |
|
|
|
|
| Secondary | Number of Participants With a Clinical Response | 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:
| Any worsening of existing signs and symptoms, or new signs and symptoms, were documented as adverse events. | Posted | Number | participants | Days 7,8,9 or 10 |
|
|
|
| Secondary | Adverse Events (AEs) and Serious AEs (SAEs) | All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported. | All subjects who received at least 1 dose of study medication were included in the safety analyses. | Posted | Number | participants | Baseline up to 28 days |
|
|
|
| 0 |
| 19 |
| 4 |
| 19 |
| EG001 | 30 mg/kg Azithromycin IR | 0 | 19 | 5 | 19 |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Treatment failure | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.1) | 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.
| Organic Chemicals |
| Serum Concentration 3 hour postdose |
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| Serum Concentration 4 hour postdose |
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| Serum Concentration 8 hour postdose |
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| Serum Concentration 24 hour postdose |
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| Serum Concentration 48 hour postdose |
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| Serum Concentration 72 hour postdose |
|
| ANOVA |
| Ratio of Geometric means (percent) |
| 50.57 |
| 90 |
| 25.24 |
| 101.30 |
Ratio (percent) = Test/Reference multiplied by 100 |
| No |
| Superiority or Other |
| Serum Concentration 3 hours postdose | ANOVA | Ratio of Geometric means (percent) | 100.07 | 90 | 57.91 | 172.92 | Ratio (percent) = Test/Reference multiplied by 100 | No | Superiority or Other |
| Serum Concentration 4 hours postdose | ANOVA | Ratio of Geometric means (percent) | 164.93 | 90 | 103.78 | 262.12 | Ratio (percent) = Test/Reference multiplied by 100 | No | Superiority or Other |
| Serum Concentration 8 hours postdose | ANOVA | Ratio of Geometric means (percent) | 174.41 | 90 | 110.07 | 276.36 | Ratio (percent) = Test/Reference multiplied by 100 | No | Superiority or Other |
| Serum Concentration 24 hours postdose | ANOVA | Ratio of Geometric means (percent) | 173.01 | 90 | 111.45 | 268.55 | Ratio (percent) = Test/Reference multiplied by 100 | No | Superiority or Other |
| Serum Concentration 48 hours postdose | ANOVA | Ratio of Geometric means (percent) | 189.35 | 90 | 129.76 | 276.30 | Ratio (percent) = Test/Reference multiplied by 100 | No | Superiority or Other |
| Serum Concentration 72 hours postdose | ANOVA | Ratio of Geometric means (percent) | 183.14 | 90 | 124.61 | 269.14 | Ratio (percent) = Test/Reference multiplied by 100 | No | Superiority or Other |