Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00827502
First received: January 21, 2009
Last updated: April 25, 2011
Last verified: April 2011

January 21, 2009
April 25, 2011
February 2009
July 2009   (final data collection date for primary outcome measure)
  • Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]
    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.
Investigator assessment of clinical outcome (success/failure) at end of study. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00827502 on ClinicalTrials.gov Archive Site
Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
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).
  • To determine safety and tolerability of Trulimax (azithromycin) treatment in patients suffering from URTIs. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Pharmacoeconomic analysis of management of URTIs shall be attempted [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections
Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections

To assess effectiveness of Trulimax (Azithromycin) in Acute Bacterial Upper Respiratory Tract Infections (URTIs).

Prospective, Open-label, Non-interventional and Multi-center Study NA

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Upper Respiratory Tract Infections
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
421
July 2009
July 2009   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00827502
A0661198
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP