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

Last updated on November 7, 2019

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Study Location
Pfizer Investigational Site
Jn Vishakhapatnam, Andhra Pradesh, 530001 India
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Upper Respiratory Tract Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

N/A

NCT00827502
Pfizer
Completed
Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections

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Descriptive Information
Brief TitleTrulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections
Official TitleTrulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections
Brief SummaryTo assess effectiveness of Trulimax (Azithromycin) in Acute Bacterial Upper Respiratory Tract Infections (URTIs).
Detailed DescriptionProspective, Open-label, Non-interventional and Multi-center Study NA
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationOnly patients with acute URTI, presumed to be of bacterial origin as per the clinical judgment of the investigator will be enrolled in the study.
ConditionUpper Respiratory Tract Infections
InterventionNot Provided
Study Groups/CohortsNot 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 StatusCompleted
Actual Enrollment
 (submitted: May 17, 2010)
421
Original Estimated Enrollment
 (submitted: January 21, 2009)
400
Actual Study Completion DateJuly 2009
Actual Primary Completion DateJuly 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesIndia
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00827502
Other Study ID NumbersA0661198
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2011

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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