N/A
N=335
Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)
Respiratory Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT01075204 ↗Enrolled (actual)
335
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Percentage of Participants With a Fast Recovery — 12.8; 54.3; 27.4; 29.7 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- clarithromycin modified release 500 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Fast Recovery |
12.8; 54.3; 27.4; 29.7; 37.1; 42.6 | — |
| PRIMARY Percentage of Participants With Clinical Success |
86.9 | — |
| PRIMARY Classification of Overall Response |
43; 248; 44 | — |
| SECONDARY Percentage of Participants With Treatment Failure |
13.1; 0.9; 3.9; 6.9; 1.5 | — |
| SECONDARY Factors Affecting the Speed of Recovery |
-0.007; 0.216; 0.004; 0.419; -0.456; 0.140 | 0.334 |
| SECONDARY Number of Participants With Adverse Events |
2; 0 | — |
| SECONDARY Fever Status at End of Study |
120; 70; 5; 140 | — |
| SECONDARY Cough Status at End of Study |
93; 100; 23; 4; 113 | — |
| SECONDARY Sputum Status at End of Study |
88; 102; 19; 4; 120 | — |
| SECONDARY Dyspnea Status at End of Study |
31; 28; 2; 1; 273 | — |
| SECONDARY Abnormal Breathing Sounds Status at End of Study |
30; 13; 4; 288 | — |
| SECONDARY Rhinorrhea Status at End of Study |
55; 56; 2; 222 | — |
| SECONDARY Post-nasal Discharge Status at End of Study |
75; 98; 6; 154 | — |
| SECONDARY Percentage of Participants Compliant With Treatment |
43; 54; 3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01075204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.