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

Respiratory Tract Infection Clinical Trial

— CLOSER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075204
• Other study ID #: P11-989
• Status: Completed
• Phase: N/A
• First received: February 23, 2010
• Last updated: February 6, 2013
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2013
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics CommitteeEgypt: Ministry of Health and Population
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

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 (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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Drug:
• clarithromycin modified release 500 mg
clarithromycin modified release 500 mg for 7 days

Locations

Country	Name	City	State
Egypt	Site Ref # / Investigator 50162	Cairo
Egypt	Site Ref # / Investigator 50215	Cairo
Egypt	Site Ref # / Investigator 50225	Cairo
Egypt	Site Ref # / Investigator 50235	Cairo
Egypt	Site Ref # / Investigator 50236	Cairo
Egypt	Site Ref # / Investigator 50237	Cairo
Egypt	Site Ref # / Investigator 51204	Cairo
Egypt	Site Ref # / Investigator 51205	Cairo
Egypt	Site Ref # / Investigator 50213	Helwan
Egypt	Site Ref # / Investigator 51206	Tanta
Egypt	Site Ref # / Investigator 51207	Tanta
Saudi Arabia	Site Ref # / Investigator 22543	Jeddah

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Eilaf CRO

Countries where clinical trial is conducted

Egypt,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Percentage of Participants With Treatment Failure	Treatment failure is defined as failure to return to baseline symptom status (symptom status prior to the onset of the respiratory tract infection) within 10 days or the need for new treatments or medications during the first 10 days for persistence or aggravation of symptoms.; Participants with treatment failure were further categorized as: All symptoms improved but not resolved within the study period; Some symptoms improved and some resolved; Some symptoms resolved or improved while other symptoms did not improve (unchanged); Some symptoms resolved or improved while other symptoms became worse.	10 days	No
Secondary	Factors Affecting the Speed of Recovery	Factors affecting the speed of recovery were examined and tested for association with the speed of recovery. Logistic regression was conducted to assess whether the following nine variables; age, gender, body mass index (BMI), concomitant tobacco use, steroid use, bronchial asthma, allergic rhinitis, nasal septum deviation and chronic obstructive pulmonary disease (COPD) act as predictors for speed of recovery of respiratory tract infections. Data shown are the beta regression coefficients for each variable.	10 days	No
Secondary	Number of Participants With Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment.; If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above.; Please see Adverse Events section below for more details.	10 days	Yes
Secondary	Fever Status at End of Study	Participants with fever (temperature over 37.0 degree of Celsius) at any time during the study were classified at the end of study as resolved, improved or no change. 'No fever' indicates participants with no fever during the study period.	10 days	No
Secondary	Cough Status at End of Study	Participants with cough at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No cough' indicates participants with no cough symptoms during the study period.	10 days	No
Secondary	Sputum Status at End of Study	Participants with sputum symptoms at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No sputum' indicates participants with no sputum symptoms during the study period.	10 days	No
Secondary	Dyspnea Status at End of Study	Participants with dyspnea (shortness of breath) at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No dyspnea' indicates participants with no dyspnea symptoms during the study period.	10 days	No
Secondary	Abnormal Breathing Sounds Status at End of Study	Participants with abnormal breathing sounds such as wheezing or rales at any time during the study were classified at the end of study as resolved, improved, or no change. 'No abnormal breath sounds' indicates participants with no abnormal breathing sounds during the study period.	10 days	No
Secondary	Rhinorrhea Status at End of Study	Participants with rhinorrhea (runny nose) at any time during the study were classified at the end of study as resolved, or no change. 'No rhinorrhea' indicates participants with no rhinorrhea during the study period.	10 days	No
Secondary	Post-nasal Discharge Status at End of Study	Participants with post-nasal discharge at any time during the study were classified at the end of study as resolved, improved, or no change. 'No post-nasal discharge' indicates participants with no post-nasal discharge symptoms during the study period.	10 days	No
Secondary	Percentage of Participants Compliant With Treatment	Treatment compliance was assessed by the study physician at each study visit. The percentage of participants who were compliant with study treatment for 6 days, 7 days and 8 days is reported.	10 days	No