Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections
NCT00827502
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Adult Trials: 18+ Years
- 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.
N/A
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections | |||
| Official Title | Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections | |||
| 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 | |||
| Study Type | Observational | |||
| Study Design | Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | 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. | |||
| Condition | Upper Respiratory Tract Infections | |||
| Intervention | Not Provided | |||
| Study Groups/Cohorts | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 421 | |||
| Original Estimated Enrollment | 400 | |||
| Actual Study Completion Date | July 2009 | |||
| Actual Primary Completion Date | July 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: N/A | |||
| Sex/Gender |
| |||
| Ages | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | India | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00827502 | |||
| Other Study ID Numbers | A0661198 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2011 | |||