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

July 1, 2011 updated by: Abbott

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

760

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bangkok, Thailand, 10160
        • Site Reference ID/Investigator# 27453
      • Bangkok, Thailand, 10210
        • Site Reference ID/Investigator# 27450
      • Bangkok, Thailand, 10220
        • Site Reference ID/Investigator# 27448
      • Bangkok, Thailand, 10400
        • 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# 27451
      • Bangkok, Thailand, 10600
        • Site Reference ID/Investigator# 27452
      • Bangkok, Thailand, 10900
        • Site Reference ID/Investigator# 27449
      • Chiangmai, Thailand, 50180
        • Site Reference ID/Investigator# 27454
      • Chonburi, Thailand, 20110
        • Site Reference ID/Investigator# 27466
      • Chonburi, Thailand, 20150
        • Site Reference ID/Investigator# 27465
      • Kanchanaburi, Thailand, 71000
        • Site Reference ID/Investigator# 27469
      • Nakhon Phanom, Thailand, 48000
        • Site Reference ID/Investigator# 27455
      • Nakonratchasima, Thailand, 30000
        • Site Reference ID/Investigator# 27461
      • Nakonratchasima, Thailand, 30000
        • Site Reference ID/Investigator# 27462
      • Nakonratchasima, Thailand, 30000
        • Site Reference ID/Investigator# 27463
      • Nong khai, Thailand, 43000
        • Site Reference ID/Investigator# 27457
      • Nong khai, Thailand, 43110
        • Site Reference ID/Investigator# 27458
      • Rayong, Thailand, 21000
        • Site Reference ID/Investigator# 27467
      • Songkhla, Thailand, 90110
        • Site Reference ID/Investigator# 27470
      • Surat Thani, Thailand, 84000
        • Site Reference ID/Investigator# 27472
      • Surat Thani, Thailand, 84130
        • Site Reference ID/Investigator# 27471
      • Ubonratchathani, Thailand, 34000
        • Site Reference ID/Investigator# 27459
      • Udornthani, Thailand, 41000
        • Site Reference ID/Investigator# 27456
      • Utaradit, Thailand, 53000
        • Site Reference ID/Investigator# 27464

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatients in Thailand

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (ESTIMATE)

February 26, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 12, 2011

Last Update Submitted That Met QC Criteria

July 1, 2011

Last Verified

June 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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