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

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

Official Title
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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.

Conditions
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Lower Respiratory Tract Infection

Intervention / Treatment
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* Drug: clarithromycin (Klacid) granules for oral suspension


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with lower respiratory tract infection<br>Thai children with lower respiratory tract infections on Klacid Granules for Oral Suspension | Drug: clarithromycin (Klacid) granules for oral suspension<br>* clarithromycin (Klacid) Granules for Oral Suspension<br>* Other names: Biaxin XL;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-marketing observational study, Lower respiratory tract infections, Klacid Granules for Oral Suspension