Clinical trial NCT01075204: Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)
Official title: Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infection
Keywords: Respiratory Tract Infection
Clarithromycin
Recovery
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Eilaf
First posted: 2010-02-25
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With a Fast Recovery
timeFrame: Day 1 to Day 5
measure: Percentage of Participants With Clinical Success
timeFrame: 10 days
measure: Classification of Overall Response
timeFrame: 10 days
Secondary outcomes:
measure: Percentage of Participants With Treatment Failure
timeFrame: 10 days
measure: Factors Affecting the Speed of Recovery
timeFrame: 10 days
measure: Number of Participants With Adverse Events
timeFrame: 10 days
measure: Fever Status at End of Study
timeFrame: 10 days
measure: Cough Status at End of Study
timeFrame: 10 days
measure: Sputum Status at End of Study
timeFrame: 10 days
measure: Dyspnea Status at End of Study
timeFrame: 10 days
measure: Abnormal Breathing Sounds Status at End of Study
timeFrame: 10 days
measure: Rhinorrhea Status at End of Study
timeFrame: 10 days
measure: Post-nasal Discharge Status at End of Study
timeFrame: 10 days
measure: Percentage of Participants Compliant With Treatment
timeFrame: 10 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Site Ref # / Investigator 50162
city: Cairo
country: Egypt
facility: Site Ref # / Investigator 50215
city: Cairo
country: Egypt
facility: Site Ref # / Investigator 50225
city: Cairo
country: Egypt
facility: Site Ref # / Investigator 50235
city: Cairo
country: Egypt
facility: Site Ref # / Investigator 50236
city: Cairo
country: Egypt
facility: Site Ref # / Investigator 50237
city: Cairo
country: Egypt
facility: Site Ref # / Investigator 51204
city: Cairo
country: Egypt
facility: Site Ref # / Investigator 51205
city: Helwan
country: Egypt
facility: Site Ref # / Investigator 50213
city: Tanta
country: Egypt
facility: Site Ref # / Investigator 51206
city: Tanta
country: Egypt
facility: Site Ref # / Investigator 51207
city: Jeddah
country: Saudi Arabia
facility: Site Ref # / Investigator 22543
Study officials:
affiliation: Abbott Laboratories - Saudi Arabia
name: Mohamed Tahoun, Bachelor
role: STUDY_DIRECTOR
References: