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

Abbott

Status: Completed

Conditions: Lower Respiratory Tract Infection

Treatments: Drug: clarithromycin (Klacid) granules for oral suspension

Study type: Observational

Funder types: Industry

Identifiers

NCT01076166

P10-813

Details and patient eligibility

About

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

Enrollment: 337 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

337 participants in 1 patient group

Children with lower respiratory tract infection

Description:

Thai children with lower respiratory tract infections on Klacid Granules for Oral Suspension

Treatment:

Drug: clarithromycin (Klacid) granules for oral suspension