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

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

337 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-01-31

Brief Summary

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Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections.

Detailed Description

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Conditions

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Lower Respiratory Tract Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DRUG

clarithromycin (Klacid) Granules for Oral Suspension

Interventions

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clarithromycin (Klacid) granules for oral suspension

clarithromycin (Klacid) Granules for Oral Suspension

Intervention Type DRUG

Other Intervention Names

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clarithromycin Klacid Granules for Oral Suspension Biaxin XL

Eligibility Criteria

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Inclusion Criteria

* Patients with lower respiratory tract infection.
* 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

* 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
* Ritonavir.
* Severe immunodeficiency and chronic disease conditions.
* Renal or hepatic impairment.
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

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 Status

Site Reference ID/Investigator# 46824

Bangkok, , Thailand

Site Status

Site Reference ID/Investigator# 16261

Bangkok, , Thailand

Site Status

Site Reference ID/Investigator# 46825

Bangkok, , Thailand

Site Status

Site Reference ID/Investigator# 27428

Bangkok, , Thailand

Site Status

Site Reference ID/Investigator# 27425

Bangkok, , Thailand

Site Status

Site Reference ID/Investigator# 27423

Bangkok, , Thailand

Site Status

Site Reference ID/Investigator# 27426

Bangkok, , Thailand

Site Status

Site Reference ID/Investigator# 46823

Chiang Mai, , Thailand

Site Status

Site Reference ID/Investigator# 27434

Chumphon, , Thailand

Site Status

Site Reference ID/Investigator# 27433

Chumphon, , Thailand

Site Status

Site Reference ID/Investigator# 27431

Nakhon Ratchasima, , Thailand

Site Status

Site Reference ID/Investigator# 27441

Nong Khai, , Thailand

Site Status

Site Reference ID/Investigator# 27429

Phitsanulok, , Thailand

Site Status

Site Reference ID/Investigator# 27432

Rayong, , Thailand

Site Status

Site Reference ID/Investigator# 27430

Samutsakorn, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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P10-813

Identifier Type: -

Identifier Source: org_study_id

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