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

Lower Respiratory Tract Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076166
• Other study ID #: P10-813
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: April 7, 2011
• Start date: April 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Lower Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Drug:
• clarithromycin (Klacid) granules for oral suspension
clarithromycin (Klacid) Granules for Oral Suspension

Locations

Country	Name	City	State
Thailand	Site Reference ID/Investigator# 16261	Bangkok
Thailand	Site Reference ID/Investigator# 27423	Bangkok
Thailand	Site Reference ID/Investigator# 27424	Bangkok
Thailand	Site Reference ID/Investigator# 27425	Bangkok
Thailand	Site Reference ID/Investigator# 27426	Bangkok
Thailand	Site Reference ID/Investigator# 27428	Bangkok
Thailand	Site Reference ID/Investigator# 46824	Bangkok
Thailand	Site Reference ID/Investigator# 46825	Bangkok
Thailand	Site Reference ID/Investigator# 46823	Chiangmai
Thailand	Site Reference ID/Investigator# 27433	Chumphon
Thailand	Site Reference ID/Investigator# 27434	Chumphon
Thailand	Site Reference ID/Investigator# 27431	Nakhon Ratchasima
Thailand	Site Reference ID/Investigator# 27441	Nong khai
Thailand	Site Reference ID/Investigator# 27429	Pisanuloke
Thailand	Site Reference ID/Investigator# 27432	Rayong
Thailand	Site Reference ID/Investigator# 27430	Samutsakorn

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Time From Baseline to Recovery From Fever and Other Symptoms	Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment 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, fever, cough, chest/abdominal pain, and vomiting. Recovery was defined as the disappearance of all signs and symptoms of infection.	Baseline to 14 days	No
Secondary	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 are summarized. See the Reported Adverse Event section for details.	Baseline to 14 days	Yes