Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)

NCT01075204 | Completed Results

• 1 other identifier: P11-989
• Study Type: observational
• Target: 335
• Locations: 2 countries
• Sites: 12

Brief Summary

The objective is to describe the time to recovery of symptoms (cough, mucus, fever, sore throat, and others), tolerability and compliance of treatment with clarithromycin once daily in patients with upper or lower respiratory tract infections in the routine clinical practice.

Conditions

Respiratory Tract Infection

Keywords

Respiratory Tract Infection; Clarithromycin; Recovery

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With a Fast Recovery

  Fast recovery is defined as the resolution of symptoms within 5 days or less from the start of clarithromycin modified release treatment. Recovery is defined as returning to the symptom status prior to the onset of the respiratory tract infection, based on the participant and physician's assessment. Data are reported for all symptoms taken together (all symptoms resolved within 5 days) and for each individual symptom.

  Day 1 to Day 5

• Percentage of Participants With Clinical Success

  Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.

  10 days

• Classification of Overall Response

  Based on the participant and physician's assessment, overall symptom response was classified as follows: * Fast Responders: participants showing clinical recovery of all symptoms within the first 5 days of treatment. * Slow Responders: participants showing clinical recovery between Day 6 \& Day 10 (includes participants with a fast response for some symptoms and slow response for the remaining symptoms). * Failure response: participants showing no clinical success by Day 10, or showing need for another anti-infective treatment to resolve aggravated symptoms (includes participants with a failure response for some symptoms and either a slow or fast response for the remaining symptoms).

  10 days

Secondary Outcomes (11)

• Percentage of Participants With Treatment Failure

  10 days

• Factors Affecting the Speed of Recovery

  10 days

• Number of Participants With Adverse Events

  10 days

• Fever Status at End of Study

  10 days

• Cough Status at End of Study

  10 days

Study Arms (1)

Clarithromycin modified release

Patients with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.

Drug: clarithromycin modified release 500 mg

Interventions

clarithromycin modified release 500 mg DRUG

clarithromycin modified release 500 mg for 7 days

Also known as: Clarithromycin Modified Release 500 mg (Klacid XL)

Clarithromycin modified release

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

Assignment to clarithromycin therapy falls within current clinical practice and was not decided in advance by this protocol. Study participants were selected from patients seen at the primary care clinic, with a preliminary clinical diagnosis of an upper or lower respiratory tract infection who were considered for antibiotic treatment and prescribed clarithromycin.

You may qualify if:

• Adults, equal to or more than 18 years years of age
• Patients with respiratory tract infections, including any of the following:
• Acute tracheitis, acute tracheobronchitis
• Acute sinusitis
• Chronic sinusitis
• Acute tonsillopharyngitis
• Acute bronchitis
• Mild community-acquired pneumonia
• Acute exacerbation of chronic bronchitis

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 (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm).
• Mental condition rendering the subject unable to understand the nature of the study.

Sponsors & Collaborators

• Abbott: lead
• Eilaf: collaborator

Study Sites (12)

Site Ref # / Investigator 50162

Cairo, Egypt

Location

Site Ref # / Investigator 50215

Cairo, Egypt

Location

Site Ref # / Investigator 50225

Cairo, Egypt

Location

Site Ref # / Investigator 50235

Cairo, Egypt

Location

Site Ref # / Investigator 50236

Cairo, Egypt

Location

Site Ref # / Investigator 50237

Cairo, Egypt

Location

Site Ref # / Investigator 51204

Cairo, Egypt

Location

Site Ref # / Investigator 51205

Cairo, Egypt

Location

Site Ref # / Investigator 50213

Helwan, Egypt

Location

Site Ref # / Investigator 51206

Tanta, Egypt

Location

Site Ref # / Investigator 51207

Tanta, Egypt

Location

Site Ref # / Investigator 22543

Jeddah, 21461, Saudi Arabia

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Esther Oppermann, Clinical Trial Manager
• Organization: Abbott

esther.oppermann@abbott.com

49 511 6750 3954

Study Officials

• Mohamed Tahoun, Bachelor

  Abbott Laboratories - Saudi Arabia

  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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 25, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 12, 2013
• Results First Posted: January 30, 2013

Record last verified: 2013-02

Locations

SA (1); EG (11)