N/A
N=466
Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Mycobacterium Infections, Atypical
Bottom Line
View on ClinicalTrials.gov: NCT01097005 ↗Enrolled (actual)
466
Serious AEs
7.9%
Results posted
Sep 2016
Primary outcome: Primary: Bacilli Negative Conversion Rate — 269 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Mylan Inc.
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bacilli Negative Conversion Rate |
269 | — |
| SECONDARY Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator |
217; 13; 10; 9 | — |
| SECONDARY Bacteriological Relapse Related to Duration of Clarithromycin Administration |
5; 0 | — |
Summary
To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.
Eligibility Criteria
Inclusion Criteria
- Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid
Exclusion Criteria
- Contraindications according to the package insert
- Patients with a history of hypersensitivity to any ingredient of Klaricid
- Patients who are receiving pimozide, ergot-containing products, or cisapride
- Patients who have AIDS (Acquired Immune Deficiency Syndrome)
Data sourced from ClinicalTrials.gov (NCT01097005). 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.