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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01076153
First received: February 24, 2010
Last updated: July 1, 2011
Last verified: June 2011

February 24, 2010
July 1, 2011
December 2008
April 2010   (final data collection date for primary outcome measure)
Average Time From Baseline to Recovery From Cough and Other Symptoms [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
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.
Average time from baseline to recovery from cough, fever and sore throat [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01076153 on ClinicalTrials.gov Archive Site
Number and Type of Adverse Events [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: Yes ]
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.
Number and type of adverse events [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR
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

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

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

Outpatients in Thailand

Respiratory Tract Infection
Drug: Clarithromycin (Klacid® MR)
Klacid MR 500mg (clarithromycin)
Other Names:
  • Clarithromycin
  • Klacid MR
  • Biaxin XL
Patients with respiratory tract infection
Thai patients with upper or lower respiratory tract infections on Klacid MR.
Intervention: Drug: Clarithromycin (Klacid® MR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
760
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01076153
P08-331
No
Savary Om/ Regional Medical Director, Abbott Laboratories
Abbott
Not Provided
Study Director: Savary Om, M.D. Abbott
Abbott
June 2011

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