N/A N=337

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

Lower Respiratory Tract Infection

Bottom Line

View on ClinicalTrials.gov: NCT01076166 ↗

Enrolled (actual)

337

Serious AEs

0.6%

Results posted

Mar 2011

Primary outcome: Primary: Average Time From Baseline to Recovery From Fever and Other Symptoms — 7.18; 7.14; 7.88 Days

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: clarithromycin (Klacid) granules for oral suspension (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Abbott
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Time From Baseline to Recovery From Fever and Other Symptoms	7.18; 7.14; 7.88	—
SECONDARY Number and Type of Adverse Events	2; 1	—

Summary

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

Eligibility 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.

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Data sourced from ClinicalTrials.gov (NCT01076166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.