Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.
NCT ID: NCT01076166
Last Updated: 2011-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
337 participants
OBSERVATIONAL
2009-04-30
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children with lower respiratory tract infection
Thai children with lower respiratory tract infections on Klacid Granules for Oral Suspension
clarithromycin (Klacid) granules for oral suspension
clarithromycin (Klacid) Granules for Oral Suspension
Interventions
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clarithromycin (Klacid) granules for oral suspension
clarithromycin (Klacid) Granules for Oral Suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is male or female \> 6 months and \< 12 years of age.
* Prescription of Klacid Granules for Oral Suspension is at the discretion of the investigators according to the clinical condition of the patients
* Patients who are suitable for treatment with Klacid Granules for Oral Suspension according to the Prescribing Information
Exclusion Criteria
* 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
* Ritonavir.
* Severe immunodeficiency and chronic disease conditions.
* Renal or hepatic impairment.
6 Months
12 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott Laboratories
Principal Investigators
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Savary Om, M.D.
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Reference ID/Investigator# 27424
Bangkok, , Thailand
Site Reference ID/Investigator# 46824
Bangkok, , Thailand
Site Reference ID/Investigator# 16261
Bangkok, , Thailand
Site Reference ID/Investigator# 46825
Bangkok, , Thailand
Site Reference ID/Investigator# 27428
Bangkok, , Thailand
Site Reference ID/Investigator# 27425
Bangkok, , Thailand
Site Reference ID/Investigator# 27423
Bangkok, , Thailand
Site Reference ID/Investigator# 27426
Bangkok, , Thailand
Site Reference ID/Investigator# 46823
Chiang Mai, , Thailand
Site Reference ID/Investigator# 27434
Chumphon, , Thailand
Site Reference ID/Investigator# 27433
Chumphon, , Thailand
Site Reference ID/Investigator# 27431
Nakhon Ratchasima, , Thailand
Site Reference ID/Investigator# 27441
Nong Khai, , Thailand
Site Reference ID/Investigator# 27429
Phitsanulok, , Thailand
Site Reference ID/Investigator# 27432
Rayong, , Thailand
Site Reference ID/Investigator# 27430
Samutsakorn, , Thailand
Countries
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Other Identifiers
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P10-813
Identifier Type: -
Identifier Source: org_study_id
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