Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.

A Multi-center, Post-Marketing Observational Study to Identify the Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid Granules for Oral Suspension.

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

Study Overview

• Status: Completed
• Conditions: Lower Respiratory Tract Infection
• Intervention / Treatment: Drug: clarithromycin (Klacid) granules for oral suspension

• Study Type: Observational
• Enrollment (Actual): 337

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10110
    • Site Reference ID/Investigator# 27424
  • Bangkok, Thailand, 10120
    • Site Reference ID/Investigator# 46824
  • Bangkok, Thailand, 10160
    • Site Reference ID/Investigator# 16261
  • Bangkok, Thailand, 10160
    • Site Reference ID/Investigator# 46825
  • Bangkok, Thailand, 10220
    • Site Reference ID/Investigator# 27428
  • Bangkok, Thailand, 10260
    • Site Reference ID/Investigator# 27425
  • Bangkok, Thailand, 10700
    • Site Reference ID/Investigator# 27423
  • Bangkok, Thailand, 10900
    • Site Reference ID/Investigator# 27426
  • Chiangmai, Thailand, 50180
    • Site Reference ID/Investigator# 46823
  • Chumphon, Thailand, 86000
    • Site Reference ID/Investigator# 27434
  • Chumphon, Thailand, 86110
    • Site Reference ID/Investigator# 27433
  • Nakhon Ratchasima, Thailand, 30000
    • Site Reference ID/Investigator# 27431
  • Nong khai, Thailand, 43110
    • Site Reference ID/Investigator# 27441
  • Pisanuloke, Thailand, 65000
    • Site Reference ID/Investigator# 27429
  • Rayong, Thailand, 21000
    • Site Reference ID/Investigator# 27432
  • Samutsakorn, Thailand, 74000
    • Site Reference ID/Investigator# 27430

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Out-patients in Thailand

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with lower respiratory tract infection; Thai children with lower respiratory tract infections on Klacid Granules for Oral Suspension	Drug: clarithromycin (Klacid) granules for oral suspension; clarithromycin (Klacid) Granules for Oral Suspension; Other Names: clarithromycin; Biaxin XL; Klacid Granules for Oral Suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Time From Baseline to Recovery From Fever and Other Symptoms	Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment 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, fever, cough, chest/abdominal pain, and vomiting. 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	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 are summarized. See the Reported Adverse Event section for details.	Baseline to 14 days

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 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): April 11, 2011
• Last Update Submitted That Met QC Criteria: April 7, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Post-marketing observational study; Lower respiratory tract infections; Klacid Granules for Oral Suspension
• 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: P10-813