Trial Outcomes & Findings for Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections (NCT NCT01097005)
NCT ID: NCT01097005
Last Updated: 2022-03-31
Results Overview
Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin
Recruitment status
COMPLETED
Target enrollment
466 participants
Primary outcome timeframe
During the treatment with clarithromycin, from 40 days to 1232 days
Results posted on
2022-03-31
Participant Flow
Patients will be registered using a central registration system. The investigators will register eligible patients with the registration center via FAX by 7 days after initiation of clarithromycin treatment.
Participant milestones
| Measure |
Clarithromycin
Those with an exposure
|
|---|---|
|
Overall Study
STARTED
|
466
|
|
Overall Study
Analysis of Safety
|
441
|
|
Overall Study
Analysis of NTM Lung Disease
|
340
|
|
Overall Study
Analysis of Bacilli Negative Conversion
|
285
|
|
Overall Study
Analysis of CGI
|
249
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
365
|
Reasons for withdrawal
| Measure |
Clarithromycin
Those with an exposure
|
|---|---|
|
Overall Study
Case Report Form not collected
|
18
|
|
Overall Study
Subjects cannot visit the hospital
|
1
|
|
Overall Study
Poor medication compliance
|
1
|
|
Overall Study
No examination data available
|
244
|
|
Overall Study
Deviation from exclusion criteria
|
37
|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Discontinuance by complication
|
50
|
Baseline Characteristics
Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Baseline characteristics by cohort
| Measure |
Clarithromycin
n=340 Participants
Those with an exposure
|
|---|---|
|
Age, Customized
<45 years
|
15 participants
n=99 Participants
|
|
Age, Customized
45-64 years
|
136 participants
n=99 Participants
|
|
Age, Customized
65-74 years
|
126 participants
n=99 Participants
|
|
Age, Customized
>=75 years
|
62 participants
n=99 Participants
|
|
Age, Customized
unknown
|
1 participants
n=99 Participants
|
|
Sex/Gender, Customized
Female
|
256 participants
n=99 Participants
|
|
Sex/Gender, Customized
Male
|
83 participants
n=99 Participants
|
|
Sex/Gender, Customized
unknown
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: During the treatment with clarithromycin, from 40 days to 1232 daysPopulation: Analysis of the bacilli negative conversion
Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin
Outcome measures
| Measure |
Clarithromycin
n=285 Participants
Negative conversion / Yes
|
|---|---|
|
Bacilli Negative Conversion Rate
|
269 participants
|
SECONDARY outcome
Timeframe: When treatment with clarithromycin is discontinued, from 40 days to 1232 daysPopulation: Analysis of Clinical Global Improvement (CGI). Number of patients with each rank scale.
Number of participants who evaluated for efficacy of clarithromycin with the 4-rank Scales ("Effective", "Ineffective", "Deterioration", "Impossible")
Outcome measures
| Measure |
Clarithromycin
n=249 Participants
Negative conversion / Yes
|
|---|---|
|
Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator
Effective
|
217 Number of patients
|
|
Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator
Ineffective
|
13 Number of patients
|
|
Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator
Deterioration
|
10 Number of patients
|
|
Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator
Impossible to assess
|
9 Number of patients
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: End of study (completers). Analysis of bacteriological relapse.
Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion
Outcome measures
| Measure |
Clarithromycin
n=101 Participants
Negative conversion / Yes
|
|---|---|
|
Bacteriological Relapse Related to Duration of Clarithromycin Administration
0-14 months CLR
|
5 participants
|
|
Bacteriological Relapse Related to Duration of Clarithromycin Administration
≥15 months CLR
|
0 participants
|
Adverse Events
Clarithromycin
Serious events: 35 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clarithromycin
n=441 participants at risk
Those with an exposure
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Psychiatric disorders
Disorientation
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Nervous system disorders
Somnolence
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.45%
2/441 • Number of events 2 • During treatment with clarithromycin up to 3.4 years
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Investigations
Weight decreased
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Infections and infestations
Pneumonia
|
0.68%
3/441 • Number of events 3 • During treatment with clarithromycin up to 3.4 years
|
|
Infections and infestations
Bacterial infection
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Infections and infestations
Pneumonia bacterial
|
0.91%
4/441 • Number of events 4 • During treatment with clarithromycin up to 3.4 years
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.45%
2/441 • Number of events 2 • During treatment with clarithromycin up to 3.4 years
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Nervous system disorders
Loss of consciousness
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Nervous system disorders
Optic neuritis
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Cardiac disorders
Arrhythmia
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Cardiac disorders
Cardiac failure acute
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Alveoliltis allergic
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.45%
2/441 • Number of events 2 • During treatment with clarithromycin up to 3.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.68%
3/441 • Number of events 3 • During treatment with clarithromycin up to 3.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.45%
2/441 • Number of events 2 • During treatment with clarithromycin up to 3.4 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Renal and urinary disorders
Calculus urinary
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
Renal and urinary disorders
Haematuria
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
|
General disorders
Pyrexia
|
0.23%
1/441 • Number of events 1 • During treatment with clarithromycin up to 3.4 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigators will be granted by sponsor.
- Publication restrictions are in place
Restriction type: OTHER