- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01076153
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
Conditions
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
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Bangkok, Thailand, 10160
- Site Reference ID/Investigator# 27453
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Bangkok, Thailand, 10210
- Site Reference ID/Investigator# 27450
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Bangkok, Thailand, 10220
- Site Reference ID/Investigator# 27448
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Bangkok, Thailand, 10400
- Site Reference ID/Investigator# 22862
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Bangkok, Thailand, 10400
- Site Reference ID/Investigator# 27444
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Bangkok, Thailand, 10400
- Site Reference ID/Investigator# 27445
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Bangkok, Thailand, 10400
- Site Reference ID/Investigator# 27451
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Bangkok, Thailand, 10600
- Site Reference ID/Investigator# 27452
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Bangkok, Thailand, 10900
- Site Reference ID/Investigator# 27449
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Chiangmai, Thailand, 50180
- Site Reference ID/Investigator# 27454
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Chonburi, Thailand, 20110
- Site Reference ID/Investigator# 27466
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Chonburi, Thailand, 20150
- Site Reference ID/Investigator# 27465
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Kanchanaburi, Thailand, 71000
- Site Reference ID/Investigator# 27469
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Nakhon Phanom, Thailand, 48000
- Site Reference ID/Investigator# 27455
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Nakonratchasima, Thailand, 30000
- Site Reference ID/Investigator# 27461
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Nakonratchasima, Thailand, 30000
- Site Reference ID/Investigator# 27462
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Nakonratchasima, Thailand, 30000
- Site Reference ID/Investigator# 27463
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Nong khai, Thailand, 43000
- Site Reference ID/Investigator# 27457
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Nong khai, Thailand, 43110
- Site Reference ID/Investigator# 27458
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Rayong, Thailand, 21000
- Site Reference ID/Investigator# 27467
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Songkhla, Thailand, 90110
- Site Reference ID/Investigator# 27470
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Surat Thani, Thailand, 84000
- Site Reference ID/Investigator# 27472
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Surat Thani, Thailand, 84130
- Site Reference ID/Investigator# 27471
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Ubonratchathani, Thailand, 34000
- Site Reference ID/Investigator# 27459
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Udornthani, Thailand, 41000
- Site Reference ID/Investigator# 27456
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Utaradit, Thailand, 53000
- Site Reference ID/Investigator# 27464
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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:
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number and Type of Adverse Events
Time Frame: Baseline to 14 days
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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.
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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
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Disease Attributes
- Infections
- Communicable Diseases
- Respiratory Tract Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Clarithromycin
Other Study ID Numbers
- P08-331
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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