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

This study has been completed.
Sponsor:
Collaborator:
Eilaf CRO
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01075204
First received: February 23, 2010
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Respiratory Tract Infection
Drug: clarithromycin modified release 500 mg

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Percentage of Participants With a Fast Recovery [ Time Frame: Day 1 to Day 5 ] [ Designated as safety issue: No ]

    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.


  • Percentage of Participants With Clinical Success [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.

  • Classification of Overall Response [ Time Frame: 10 days ] [ Designated as safety issue: No ]

    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).


Secondary Outcome Measures:
  • Percentage of Participants With Treatment Failure [ Time Frame: 10 days ] [ Designated as safety issue: No ]

    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.

  • Factors Affecting the Speed of Recovery [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Adverse Events [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

    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.


  • Fever Status at End of Study [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.

  • Cough Status at End of Study [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.

  • Sputum Status at End of Study [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.

  • Dyspnea Status at End of Study [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.

  • Abnormal Breathing Sounds Status at End of Study [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.

  • Rhinorrhea Status at End of Study [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.

  • Post-nasal Discharge Status at End of Study [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Compliant With Treatment [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 335
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
clarithromycin modified release 500 mg for 7 days
Other Name: Clarithromycin Modified Release 500 mg (Klacid XL)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075204

Locations
Egypt
Site Ref # / Investigator 50162
Cairo, Egypt
Site Ref # / Investigator 50237
Cairo, Egypt
Site Ref # / Investigator 50215
Cairo, Egypt
Site Ref # / Investigator 50236
Cairo, Egypt
Site Ref # / Investigator 50235
Cairo, Egypt
Site Ref # / Investigator 50225
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, Egypt
Saudi Arabia
Site Ref # / Investigator 22543
Jeddah, Saudi Arabia, 21461
Sponsors and Collaborators
Abbott
Eilaf CRO
Investigators
Study Director: Mohamed Tahoun, Bachelor Abbott Laboratories - Saudi Arabia
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01075204     History of Changes
Other Study ID Numbers: P11-989
Study First Received: February 23, 2010
Results First Received: December 20, 2012
Last Updated: February 6, 2013
Health Authority: Saudi Arabia: Ethics Committee
Egypt: Ministry of Health and Population

Keywords provided by Abbott:
Respiratory Tract Infection
Clarithromycin
Recovery

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clarithromycin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014