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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01076166
First received: February 24, 2010
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention
Lower Respiratory Tract Infection
Drug: clarithromycin (Klacid) granules for oral suspension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Average Time From Baseline to Recovery From Fever and Other Symptoms [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number and Type of Adverse Events [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 337
Study Start Date: April 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
  • Klacid Granules for Oral Suspension
  • Biaxin XL

  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Out-patients in Thailand

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076166

Locations
Thailand
Site Reference ID/Investigator# 16261
Bangkok, Thailand, 10160
Site Reference ID/Investigator# 27423
Bangkok, Thailand, 10700
Site Reference ID/Investigator# 27424
Bangkok, Thailand, 10110
Site Reference ID/Investigator# 27425
Bangkok, Thailand, 10260
Site Reference ID/Investigator# 27426
Bangkok, Thailand, 10900
Site Reference ID/Investigator# 27428
Bangkok, Thailand, 10220
Site Reference ID/Investigator# 46825
Bangkok, Thailand, 10160
Site Reference ID/Investigator# 46824
Bangkok, Thailand, 10120
Site Reference ID/Investigator# 46823
Chiangmai, Thailand, 50180
Site Reference ID/Investigator# 27434
Chumphon, Thailand, 86000
Site Reference ID/Investigator# 27433
Chumphon, Thailand, 86110
Site Reference ID/Investigator# 27431
Nakhon Ratchasima, Thailand, 30000
Site Reference ID/Investigator# 27441
Nong khai, Thailand, 43110
Site Reference ID/Investigator# 27429
Pisanuloke, Thailand, 65000
Site Reference ID/Investigator# 27432
Rayong, Thailand, 21000
Site Reference ID/Investigator# 27430
Samutsakorn, Thailand, 74000
Sponsors and Collaborators
Abbott
Investigators
Study Director: Savary Om, M.D. Abbott
  More Information

No publications provided

Responsible Party: Savary Om/ Regional Medical Director, Abbott Laboratories
ClinicalTrials.gov Identifier: NCT01076166     History of Changes
Other Study ID Numbers: P10-813
Study First Received: February 24, 2010
Results First Received: January 7, 2011
Last Updated: April 7, 2011
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Abbott:
Post-marketing observational study
Lower respiratory tract infections
Klacid Granules for Oral Suspension

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014