N/A
N=760
Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR
Respiratory Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT01076153 ↗Enrolled (actual)
760
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Average Time From Baseline to Recovery From Cough and Other Symptoms — 7.06; 6.76; 7.82; 9.05 Days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Clarithromycin (Klacid® MR) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Time From Baseline to Recovery From Cough and Other Symptoms |
7.06; 6.76; 7.82; 9.05 | — |
| SECONDARY Number and Type of Adverse Events |
0; 7 | — |
Summary
The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections.
Eligibility Criteria
Inclusion Criteria
- Patients with upper or lower respiratory tract infection.
- Patient is male or female ≥ 18 years of age.
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.
Data sourced from ClinicalTrials.gov (NCT01076153). 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.