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

Respiratory Tract Infection Clinical Trial

Official title:

A Multi-center, Post-Marketing Observational Study to Identify the Recovery Time in Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076153
• Other study ID #: P08-331
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: July 1, 2011
• Start date: December 2008
• Est. completion date: April 2010

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 760
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• Clarithromycin (Klacid® MR)
Klacid MR 500mg (clarithromycin)

Locations

Country	Name	City	State
Thailand	Site Reference ID/Investigator# 22862	Bangkok
Thailand	Site Reference ID/Investigator# 27444	Bangkok
Thailand	Site Reference ID/Investigator# 27445	Bangkok
Thailand	Site Reference ID/Investigator# 27448	Bangkok
Thailand	Site Reference ID/Investigator# 27449	Bangkok
Thailand	Site Reference ID/Investigator# 27450	Bangkok
Thailand	Site Reference ID/Investigator# 27451	Bangkok
Thailand	Site Reference ID/Investigator# 27452	Bangkok
Thailand	Site Reference ID/Investigator# 27453	Bangkok
Thailand	Site Reference ID/Investigator# 27454	Chiangmai
Thailand	Site Reference ID/Investigator# 27465	Chonburi
Thailand	Site Reference ID/Investigator# 27466	Chonburi
Thailand	Site Reference ID/Investigator# 27469	Kanchanaburi
Thailand	Site Reference ID/Investigator# 27455	Nakhon Phanom
Thailand	Site Reference ID/Investigator# 27461	Nakonratchasima
Thailand	Site Reference ID/Investigator# 27462	Nakonratchasima
Thailand	Site Reference ID/Investigator# 27463	Nakonratchasima
Thailand	Site Reference ID/Investigator# 27457	Nong khai
Thailand	Site Reference ID/Investigator# 27458	Nong khai
Thailand	Site Reference ID/Investigator# 27467	Rayong
Thailand	Site Reference ID/Investigator# 27470	Songkhla
Thailand	Site Reference ID/Investigator# 27471	Surat Thani
Thailand	Site Reference ID/Investigator# 27472	Surat Thani
Thailand	Site Reference ID/Investigator# 27459	Ubonratchathani
Thailand	Site Reference ID/Investigator# 27456	Udornthani
Thailand	Site Reference ID/Investigator# 27464	Utaradit

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 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	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 is summarized. See the Reported Adverse Event section for details.	Baseline to 14 days	Yes