Upper Respiratory Tract Infections
Conditions
Keywords
TRULIMAX (AZITHROMYCIN ) NON-INTERVENTIONAL STUDY
Brief summary
To assess effectiveness of Trulimax (Azithromycin) in Acute Bacterial Upper Respiratory Tract Infections (URTIs).
Detailed description
Prospective, Open-label, Non-interventional and Multi-center Study NA
Interventions
None listed
Sponsors
Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. * Patients with acute URTI, presumed to be of bacterial origin as per the clinical judgment of the investigator.
Exclusion criteria
N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study | Baseline to 2 weeks | 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. |
| Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study | Baseline to 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | Baseline to 3 months | 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). |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Azithromycin | 410 |
| Total | 410 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | randomized but not treated | 11 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Azithromycin |
|---|---|
| Age, Customized 18-44 years | 270 participants |
| Age, Customized <18 years | 51 participants |
| Age, Customized 45-64 years | 73 participants |
| Age, Customized >= 65 years | 9 participants |
| Age, Customized Demographic information not collected | 5 participants |
| Age, Customized Unspecified | 2 participants |
| Sex/Gender, Customized Demographic information not collected | 5 participants |
| Sex/Gender, Customized Female | 155 participants |
| Sex/Gender, Customized Male | 245 participants |
| Sex/Gender, Customized Unspecified | 5 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 410 |
| serious Total, serious adverse events | 0 / 410 |
Outcome results
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.
Time frame: Baseline to 2 weeks
Population: The efficacy evaluable (EVAL) population included subjects in the FAS having at least 1 definitive follow up global response assessment to treatment of URTIs.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin | Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study | Cure | 249 Participants |
| Azithromycin | Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study | Improvement | 26 Participants |
| Azithromycin | Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study | Failure | 3 Participants |
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.
Time frame: Baseline to 2 weeks
Population: The full analysis set (FAS) included all subjects who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin | Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study | Success | 275 participants |
| Azithromycin | Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study | Failure (Unknown or missing values also included) | 133 participants |
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).
Time frame: Baseline to 3 months
Population: FAS
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Azithromycin | Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | Chest X-ray (n=9) | 150 cost (in Indian Rupees) per participant |
| Azithromycin | Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | General Consultations (n=346) | 500 cost (in Indian Rupees) per participant |
| Azithromycin | Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | Overall Study Drugs (n=390) | 170 cost (in Indian Rupees) per participant |
| Azithromycin | Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | Analgesics (n=205) | 18 cost (in Indian Rupees) per participant |
| Azithromycin | Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | Antipyretics (n=116) | 9 cost (in Indian Rupees) per participant |
| Azithromycin | Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | Anti-inflammatory (n=88) | 20 cost (in Indian Rupees) per participant |
| Azithromycin | Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | Vitamins (n=180) | 20 cost (in Indian Rupees) per participant |
| Azithromycin | Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | Other study medication (n=235) | 20 cost (in Indian Rupees) per participant |
| Azithromycin | Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | Complete Blood Count (n=15) | 200 cost (in Indian Rupees) per participant |
| Azithromycin | Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate | Erythrocyte Sedimentation Rate (n=4) | 80 cost (in Indian Rupees) per participant |