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To assess effectiveness of Trulimax (Azithromycin) in Acute Bacterial Upper Respiratory Tract Infections (URTIs).
Prospective, Open-label, Non-interventional and Multi-center Study NA
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study | Success: Cure (disappearance of all pre-treatment signs and symptoms of infection) or improvement in or partial disappearance of signs and symptoms not requiring further treatment at end of study; Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. Unknown or missing values were considered as failure. | Baseline to 2 weeks |
| Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study | Cure: Disappearance of all pre-treatment signs and symptoms of infection; Improvement: Improvement in, or partial disappearance of signs and symptoms without requiring further antibacterial therapy. Subjects who discontinued study drug for reasons other than lack of clinical response, i.e., despite clinical improvement, were included in this category; and Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. An unknown response or missing value was considered clinical failure. | Baseline to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | Cost (in Indian Rupees) per participant of utilizations including general consultations over the study; each medication over the study (study drug, analgesics, antipyretics, anti-inflammatory drugs, vitamins, other study medication), radiological tests over the study (chest X-ray); and clinical laboratory tests over the study (complete blood count and erythrocyte sedimentation rate). |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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Only patients with acute URTI, presumed to be of bacterial origin as per the clinical judgment of the investigator will be enrolled in the study.
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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 | Jn Vishakhapatnam | Andhra Pradesh | 530001 | India | ||
| 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 | Azithromycin | The use and dosage recommendations for Azithromycin took place on the basis of the approved local product document (LPD) and were adjusted solely according to medical and therapeutic necessities. According to the approved LPD, in general a total dose of 30 mg/kg was given as a single daily dose(10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on day 1, and then reduced to 5 mg/kg on days 2 to 5). For children with acute otitis media a single dose of 30 mg/kg was recommended. Children with streptococcal pharyngitis were given a single dose of 10 mg/kg or 20 mg/kg for 3 days and did not exceed a daily dose of 500mg. The maximum recommended total dose of Azithromycin in children for any treatment was 1500 mg. Azithromycin tablets were administered only to children weighing more than 45 kg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin |
| 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 Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study | Success: Cure (disappearance of all pre-treatment signs and symptoms of infection) or improvement in or partial disappearance of signs and symptoms not requiring further treatment at end of study; Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. Unknown or missing values were considered as failure. | The full analysis set (FAS) included all subjects who received at least one dose of study medication. | Posted | Number | participants | Baseline to 2 weeks |
|
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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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (12.0) | 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 |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| Baseline to 3 months |
| Visakhapatnam |
| Andhra Pradesh |
| 530 020 |
| India |
| Pfizer Investigational Site | Guwhati | Assam | 781 011 | India |
| Pfizer Investigational Site | Nagpur | Maharashtra | 440 009 | India |
| Pfizer Investigational Site | Vashi | Maharashtra | 400 075 | India |
| Pfizer Investigational Site | New Delhi | National Capital Territory of Delhi | 110 057 | India |
| Pfizer Investigational Site | New Delhi | National Capital Territory of Delhi | 110060 | India |
| Pfizer Investigational Site | Delhi | New Delhi | 110085 | India |
| Pfizer Investigational Site | Chennai | Tamil Nadu | 600 084 | India |
| Pfizer Investigational Site | Chennai | Tamil Nadu | 602 001 | India |
| Pfizer Investigational Site | Lucknow | Uttar Pradesh | 226020 | India |
| Withdrawal by Subject |
|
| participants |
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| Sex/Gender, Customized | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | Cost (in Indian Rupees) per participant of utilizations including general consultations over the study; each medication over the study (study drug, analgesics, antipyretics, anti-inflammatory drugs, vitamins, other study medication), radiological tests over the study (chest X-ray); and clinical laboratory tests over the study (complete blood count and erythrocyte sedimentation rate). | FAS | Posted | Median | Full Range | cost (in Indian Rupees) per participant | Baseline to 3 months |
|
|
|
| Primary | Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study | Cure: Disappearance of all pre-treatment signs and symptoms of infection; Improvement: Improvement in, or partial disappearance of signs and symptoms without requiring further antibacterial therapy. Subjects who discontinued study drug for reasons other than lack of clinical response, i.e., despite clinical improvement, were included in this category; and Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. An unknown response or missing value was considered clinical failure. | The efficacy evaluable (EVAL) population included subjects in the FAS having at least 1 definitive follow up global response assessment to treatment of URTIs. | Posted | Number | Participants | Baseline to 2 weeks |
|
|
|
| 0 |
| 410 |
| 16 |
| 410 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Gastric disorder | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Hyperchlorhydria | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Adverse event | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Drug intolerance | General disorders | MedDRA (12.0) | Systematic Assessment |
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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.
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| Antipyretics (n=116) |
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| Anti-inflammatory (n=88) |
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| Vitamins (n=180) |
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| Other study medication (n=235) |
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| Chest X-ray (n=9) |
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| Complete Blood Count (n=15) |
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| Erythrocyte Sedimentation Rate (n=4) |
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| Title | Measurements |
|---|
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