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

Abbott760 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

760

Conditions

Respiratory Tract Infection

Interventions

Clarithromycin (Klacid® MR)DRUG

Klacid MR 500mg (clarithromycin)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (26)

Site Reference ID/Investigator# 27453

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 14 days

Secondary Outcomes

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.

Time frame: Baseline to 14 days

Data from ClinicalTrials.gov

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