Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections.

Official Title
-----------------
A Multi-center, Post-Marketing Observational Study to Identify the Recovery Time in Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

Conditions
-----------------
Respiratory Tract Infection

Intervention / Treatment
-----------------
* Drug: Clarithromycin (Klacid® MR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with upper or lower respiratory tract infection. Patient is male or female ≥ 18 years of age. 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 Some antiretrovirals: zidovudine and ritonavir. Severe immunodeficiency and chronic disease conditions. Renal or hepatic impairment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with respiratory tract infection<br>Thai patients with upper or lower respiratory tract infections on Klacid MR. | Drug: Clarithromycin (Klacid® MR)<br>* Klacid MR 500mg (clarithromycin)<br>* Other names: Biaxin XL;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Time From Baseline to Recovery From Cough and Other Symptoms | Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) 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, cough, fever, and sore throat. 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 is summarized. See the Reported Adverse Event section for details. | Baseline to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-marketing observational study, Upper or lower respiratory tract infection, Klacid MR