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

NCT01076166 | Completed Results

• 1 other identifier: P10-813
• Study Type: observational
• Target: 337
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Lower Respiratory Tract Infection

Keywords

Post-marketing observational study; Lower respiratory tract infections; Klacid Granules for Oral Suspension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number and Type of Adverse Events

  Baseline to 14 days

Study Arms (1)

Children with lower respiratory tract infection

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

Drug: clarithromycin (Klacid) granules for oral suspension

Interventions

clarithromycin (Klacid) granules for oral suspension DRUG

clarithromycin (Klacid) Granules for Oral Suspension

Also known as: clarithromycin, Klacid Granules for Oral Suspension, Biaxin XL

Children with lower respiratory tract infection

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Out-patients in Thailand

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (16)

Site Reference ID/Investigator# 27424

Bangkok, 10110, Thailand

Location

Site Reference ID/Investigator# 46824

Bangkok, 10120, Thailand

Location

Site Reference ID/Investigator# 16261

Bangkok, 10160, Thailand

Location

Site Reference ID/Investigator# 46825

Bangkok, 10160, Thailand

Location

Site Reference ID/Investigator# 27428

Bangkok, 10220, Thailand

Location

Site Reference ID/Investigator# 27425

Bangkok, 10260, Thailand

Location

Site Reference ID/Investigator# 27423

Bangkok, 10700, Thailand

Location

Site Reference ID/Investigator# 27426

Bangkok, 10900, Thailand

Location

Site Reference ID/Investigator# 46823

Chiang Mai, 50180, Thailand

Location

Site Reference ID/Investigator# 27434

Chumphon, 86000, Thailand

Location

Site Reference ID/Investigator# 27433

Chumphon, 86110, Thailand

Location

Site Reference ID/Investigator# 27431

Nakhon Ratchasima, 30000, Thailand

Location

Site Reference ID/Investigator# 27441

Nong Khai, 43110, Thailand

Location

Site Reference ID/Investigator# 27429

Phitsanulok, 65000, Thailand

Location

Site Reference ID/Investigator# 27432

Rayong, 21000, Thailand

Location

Site Reference ID/Investigator# 27430

Samutsakorn, 74000, Thailand

Location

MeSH Terms

Interventions

Clarithromycin; Suspensions

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Savary Om, M.D.

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: April 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 11, 2011
• Results First Posted: March 7, 2011

Record last verified: 2011-04

Locations

TH (16)