Clinical trial NCT01076166: Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Respiratory Tract Infection
Keywords: Post-marketing observational study
Lower respiratory tract infections
Klacid Granules for Oral Suspension
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 337
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out-patients in Thailand

Brief 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.

Primary outcomes:
measure: Average Time From Baseline to Recovery From Fever and Other Symptoms
timeFrame: Baseline to 14 days
Secondary outcomes:
measure: Number and Type of Adverse Events
timeFrame: Baseline to 14 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27424
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 46824
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 16261
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 46825
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27428
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27425
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27423
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27426
city: Chiangmai
country: Thailand
facility: Site Reference ID/Investigator# 46823
city: Chumphon
country: Thailand
facility: Site Reference ID/Investigator# 27434
city: Chumphon
country: Thailand
facility: Site Reference ID/Investigator# 27433
city: Nakhon Ratchasima
country: Thailand
facility: Site Reference ID/Investigator# 27431
city: Nong khai
country: Thailand
facility: Site Reference ID/Investigator# 27441
city: Pisanuloke
country: Thailand
facility: Site Reference ID/Investigator# 27429
city: Rayong
country: Thailand
facility: Site Reference ID/Investigator# 27432
city: Samutsakorn
country: Thailand
facility: Site Reference ID/Investigator# 27430
Study officials:
affiliation: Abbott
name: Savary Om, M.D.
role: STUDY_DIRECTOR
References: