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
  Purpose

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


Condition Intervention
Respiratory Tract Infection
Drug: Clarithromycin (Klacid® MR)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 760
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076153

Locations
Thailand
Site Reference ID/Investigator# 22862
Bangkok, Thailand, 10400
Site Reference ID/Investigator# 27444
Bangkok, Thailand, 10400
Site Reference ID/Investigator# 27445
Bangkok, Thailand, 10400
Site Reference ID/Investigator# 27450
Bangkok, Thailand, 10210
Site Reference ID/Investigator# 27453
Bangkok, Thailand, 10160
Site Reference ID/Investigator# 27448
Bangkok, Thailand, 10220
Site Reference ID/Investigator# 27451
Bangkok, Thailand, 10400
Site Reference ID/Investigator# 27452
Bangkok, Thailand, 10600
Site Reference ID/Investigator# 27449
Bangkok, Thailand, 10900
Site Reference ID/Investigator# 27454
Chiangmai, Thailand, 50180
Site Reference ID/Investigator# 27466
Chonburi, Thailand, 20110
Site Reference ID/Investigator# 27465
Chonburi, Thailand, 20150
Site Reference ID/Investigator# 27469
Kanchanaburi, Thailand, 71000
Site Reference ID/Investigator# 27455
Nakhon Phanom, Thailand, 48000
Site Reference ID/Investigator# 27461
Nakonratchasima, Thailand, 30000
Site Reference ID/Investigator# 27462
Nakonratchasima, Thailand, 30000
Site Reference ID/Investigator# 27463
Nakonratchasima, Thailand, 30000
Site Reference ID/Investigator# 27457
Nong khai, Thailand, 43000
Site Reference ID/Investigator# 27458
Nong khai, Thailand, 43110
Site Reference ID/Investigator# 27467
Rayong, Thailand, 21000
Site Reference ID/Investigator# 27470
Songkhla, Thailand, 90110
Site Reference ID/Investigator# 27471
Surat Thani, Thailand, 84130
Site Reference ID/Investigator# 27472
Surat Thani, Thailand, 84000
Site Reference ID/Investigator# 27459
Ubonratchathani, Thailand, 34000
Site Reference ID/Investigator# 27456
Udornthani, Thailand, 41000
Site Reference ID/Investigator# 27464
Utaradit, Thailand, 53000
Sponsors and Collaborators
Abbott
Investigators
Study Director: Savary Om, M.D. Abbott
  More Information

No publications provided

Responsible Party: Savary Om/ Regional Medical Director, Abbott Laboratories
ClinicalTrials.gov Identifier: NCT01076153     History of Changes
Other Study ID Numbers: P08-331
Study First Received: February 24, 2010
Results First Received: April 22, 2011
Last Updated: July 1, 2011
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Abbott:
Post-marketing observational study
Upper or lower respiratory tract infection
Klacid MR

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clarithromycin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014