Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

NCT01076153 | Completed Results

• 1 other identifier: P08-331
• Study Type: observational
• Target: 760
• Locations: 1 country
• Sites: 26

Brief Summary

The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections.

Conditions

Respiratory Tract Infection

Keywords

Post-marketing observational study; Upper or lower respiratory tract infection; Klacid MR

Outcome Measures

Primary Outcomes (1)

• Average Time From Baseline to Recovery From Cough and Other Symptoms

  Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) 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, cough, fever, and sore throat. 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)

Patients with respiratory tract infection

Thai patients with upper or lower respiratory tract infections on Klacid MR.

Drug: Clarithromycin (Klacid® MR)

Interventions

Clarithromycin (Klacid® MR) DRUG

Klacid MR 500mg (clarithromycin)

Also known as: Clarithromycin, Klacid MR, Biaxin XL

Patients with respiratory tract infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients in Thailand

You may qualify if:

• Patients with upper or lower respiratory tract infection.
• Patient is male or female ≥ 18 years of age.

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
• Some antiretrovirals: zidovudine and ritonavir.
• Severe immunodeficiency and chronic disease conditions.
• Renal or hepatic impairment.

Sponsors & Collaborators

• Abbott: lead

Study Sites (26)

Site Reference ID/Investigator# 27453

Bangkok, 10160, Thailand

Location

Site Reference ID/Investigator# 27450

Bangkok, 10210, Thailand

Location

Site Reference ID/Investigator# 27448

Bangkok, 10220, Thailand

Location

Site Reference ID/Investigator# 22862

Bangkok, 10400, Thailand

Location

Site Reference ID/Investigator# 27444

Bangkok, 10400, Thailand

Location

Site Reference ID/Investigator# 27445

Bangkok, 10400, Thailand

Location

Site Reference ID/Investigator# 27451

Bangkok, 10400, Thailand

Location

Site Reference ID/Investigator# 27452

Bangkok, 10600, Thailand

Location

Site Reference ID/Investigator# 27449

Bangkok, 10900, Thailand

Location

Site Reference ID/Investigator# 27454

Chiang Mai, 50180, Thailand

Location

Site Reference ID/Investigator# 27466

Chon Buri, 20110, Thailand

Location

Site Reference ID/Investigator# 27465

Chon Buri, 20150, Thailand

Location

Site Reference ID/Investigator# 27469

Kanchanaburi, 71000, Thailand

Location

Site Reference ID/Investigator# 27455

Nakhon Phanom, 48000, Thailand

Location

Site Reference ID/Investigator# 27461

Nakhon Ratchasima, 30000, Thailand

Location

Site Reference ID/Investigator# 27462

Nakhon Ratchasima, 30000, Thailand

Location

Site Reference ID/Investigator# 27463

Nakhon Ratchasima, 30000, Thailand

Location

Site Reference ID/Investigator# 27457

Nong Khai, 43000, Thailand

Location

Site Reference ID/Investigator# 27458

Nong Khai, 43110, Thailand

Location

Site Reference ID/Investigator# 27467

Rayong, 21000, Thailand

Location

Site Reference ID/Investigator# 27470

Songkhla, 90110, Thailand

Location

Site Reference ID/Investigator# 27472

Surat Thani, 84000, Thailand

Location

Site Reference ID/Investigator# 27471

Surat Thani, 84130, Thailand

Location

Site Reference ID/Investigator# 27459

Ubonratchathani, 34000, Thailand

Location

Site Reference ID/Investigator# 27456

Udon Thani, 41000, Thailand

Location

Site Reference ID/Investigator# 27464

Uttaradit, 53000, Thailand

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

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: December 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 12, 2011
• Results First Posted: June 29, 2011

Record last verified: 2011-06

Locations

TH (26)