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

Completed

• Conditions: Respiratory Tract Infection
• Interventions: Drug: Clarithromycin (Klacid® MR)

• Registration Number: NCT01076153
• Lead Sponsor: Abbott

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-26
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-04-22
• Status Verified: 2011-06
• Results First Submitted QC: 2011-06-03
• Results First Posted: 2011-06-29
• Last Update Submitted: 2011-07-01
• Last Update Posted: 2011-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 760

Inclusion Criteria

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

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
  • Some antiretrovirals: zidovudine and ritonavir.

• Severe immunodeficiency and chronic disease conditions.

• Renal or hepatic impairment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with respiratory tract infection	Clarithromycin (Klacid® MR)	Thai patients with upper or lower respiratory tract infections on Klacid MR.

Primary Outcome Measures

Name	Time	Method
Average Time From Baseline to Recovery From Cough and Other Symptoms	Baseline to 14 days	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.

Secondary Outcome Measures

Name	Time	Method
Number and Type of Adverse Events	Baseline to 14 days	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 is summarized. See the Reported Adverse Event section for details.

Trial Locations

Locations (26)

Site Reference ID/Investigator# 27448; 🇹🇭 Bangkok, Thailand

Site Reference ID/Investigator# 27445; 🇹🇭 Bangkok, Thailand

Site Reference ID/Investigator# 27451; 🇹🇭 Bangkok, Thailand

Site Reference ID/Investigator# 27452; 🇹🇭 Bangkok, Thailand

Site Reference ID/Investigator# 27449; 🇹🇭 Bangkok, Thailand

Site Reference ID/Investigator# 27472; 🇹🇭 Surat Thani, Thailand

Site Reference ID/Investigator# 27456; 🇹🇭 Udornthani, Thailand

Site Reference ID/Investigator# 27466; 🇹🇭 Chonburi, Thailand

Site Reference ID/Investigator# 27458; 🇹🇭 Nong khai, Thailand

Site Reference ID/Investigator# 27467; 🇹🇭 Rayong, Thailand

Site Reference ID/Investigator# 27450; 🇹🇭 Bangkok, Thailand

Site Reference ID/Investigator# 27454; 🇹🇭 Chiangmai, Thailand

Site Reference ID/Investigator# 27469; 🇹🇭 Kanchanaburi, Thailand

Site Reference ID/Investigator# 27461; 🇹🇭 Nakonratchasima, Thailand

Site Reference ID/Investigator# 27457; 🇹🇭 Nong khai, Thailand

Site Reference ID/Investigator# 27465; 🇹🇭 Chonburi, Thailand

Site Reference ID/Investigator# 27471; 🇹🇭 Surat Thani, Thailand

Site Reference ID/Investigator# 27464; 🇹🇭 Utaradit, Thailand

Site Reference ID/Investigator# 27462; 🇹🇭 Nakonratchasima, Thailand

Site Reference ID/Investigator# 27463; 🇹🇭 Nakonratchasima, Thailand

Site Reference ID/Investigator# 27470; 🇹🇭 Songkhla, Thailand

Site Reference ID/Investigator# 27459; 🇹🇭 Ubonratchathani, Thailand

Site Reference ID/Investigator# 27453; 🇹🇭 Bangkok, Thailand

Site Reference ID/Investigator# 22862; 🇹🇭 Bangkok, Thailand

Site Reference ID/Investigator# 27444; 🇹🇭 Bangkok, Thailand

Site Reference ID/Investigator# 27455; 🇹🇭 Nakhon Phanom, Thailand