To assess effectiveness of Trulimax (Azithromycin) in Acute Bacterial Upper Respiratory Tract Infections (URTIs).
Prospective, Open-label, Non-interventional and Multi-center Study NA
Study Type
OBSERVATIONAL
Enrollment
421
Pfizer Investigational Site
Jn Vishakhapatnam, Andhra Pradesh, India
Pfizer Investigational Site
Visakhapatnam, Andhra Pradesh, India
Pfizer Investigational Site
Guwhati, Assam, India
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
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
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
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Pfizer Investigational Site
Nagpur, Maharashtra, India
Pfizer Investigational Site
Vashi, Maharashtra, India
Pfizer Investigational Site
New Delhi, National Capital Territory of Delhi, India
Pfizer Investigational Site
New Delhi, National Capital Territory of Delhi, India
Pfizer Investigational Site
Delhi, New Delhi, India
Pfizer Investigational Site
Chennai, Tamil Nadu, India
Pfizer Investigational Site
Chennai, Tamil Nadu, India
...and 1 more locations