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Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

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ClinicalTrials.gov Identifier: NCT01076153
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : June 29, 2011
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Abbott

Brief Summary:
The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections.

Condition or disease Intervention/treatment
Respiratory Tract Infection Drug: Clarithromycin (Klacid® MR)

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Study Type : Observational
Actual Enrollment : 760 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-center, Post-Marketing Observational Study to Identify the Recovery Time in Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR
Study Start Date : December 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with respiratory tract infection
Thai patients with upper or lower respiratory tract infections on Klacid MR.
Drug: Clarithromycin (Klacid® MR)
Klacid MR 500mg (clarithromycin)
Other Names:
  • Clarithromycin
  • Klacid MR
  • Biaxin XL




Primary Outcome Measures :
  1. Average Time From Baseline to Recovery From Cough and Other Symptoms [ Time Frame: Baseline to 14 days ]
    Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, cough, fever, and sore throat. Recovery was defined as the disappearance of all signs and symptoms of infection.


Secondary Outcome Measures :
  1. Number and Type of Adverse Events [ Time Frame: Baseline to 14 days ]
    Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients in Thailand
Criteria

Inclusion Criteria:

  • Patients with upper or lower respiratory tract infection.
  • Patient is male or female ≥ 18 years of age.

Exclusion Criteria:

  • Known hypersensitivity to or previously intolerant of macrolides.
  • Illness severe enough to warrant hospitalization or parenteral therapy.
  • Concomitant use of any of the following medications:

    • Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.
    • Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.
    • Colchicine
    • Digoxin
    • Some antiretrovirals: zidovudine and ritonavir.
  • Severe immunodeficiency and chronic disease conditions.
  • Renal or hepatic impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076153


Locations
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Sponsors and Collaborators
Abbott
Investigators
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Study Director: Savary Om, M.D. Abbott
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Responsible Party: Savary Om/ Regional Medical Director, Abbott Laboratories
ClinicalTrials.gov Identifier: NCT01076153    
Other Study ID Numbers: P08-331
First Posted: February 26, 2010    Key Record Dates
Results First Posted: June 29, 2011
Last Update Posted: July 12, 2011
Last Verified: June 2011
Keywords provided by Abbott:
Post-marketing observational study
Upper or lower respiratory tract infection
Klacid MR
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors