A Phase 2 interventional study of 280 mg Arikayce™ and Matching Placebo for Cohort 1 in Bronchiectasis, sponsored by Insmed Incorporated. Completed at 18 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Insmed Incorporated · Phase 2, Interventional, and Treatment
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This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.
Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis varies, but the presence of microbial infection and a persistent inflammatory response is typical of the disease. The chronic nature of the infection and the associated considerable morbidity provides the rationale for using aerosolized antibiotics for the treatment of bronchiectasis patients.
This is a multi-national Phase 2 study of safety and tolerability of 28 days of daily dosing with two dose levels (280 mg and 560 mg) of Arikayce™ versus placebo in subjects with bronchiectasis and chronic Pseudomonas infection. Study subjects will be randomized to receive either study drug or placebo by inhalation via a PARI eFlow® nebulizer. Each subject will complete 28 days of daily dosing. All study subjects will be followed for microbiologic activity for 14 days after completion of treatment and for safety for 28 days post completion of study treatment.
The total study duration will be 56 days, with the screening visit occurring within the preceding 14 days prior to study day 1. At Day 1 (baseline), subjects will be evaluated at pre-dose and during the first 4-5 hours post-dose. Subjects will return at Week 2 (day 14) after start of treatment and at the end of Week 4 (Day 28) treatment period to determine safety and efficacy of Arikayce™. Subjects will be followed up on study Days 42 and 56 (about 2 and 4 weeks after end of treatment) for safety determination. After completion of this study, subjects will be followed up for an additional 6 months via phone contacts and records review, if hospitalized or treated for pulmonary exacerbation (under the extension protocol).
Clinical laboratory parameters, audiology testing, clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the qualitative and quantitative safety and tolerability of Arikayce™ compared to placebo. Serum, urine and sputum specimens will be collected at periodic intervals to assess pharmacokinetics (PK) in subjects who consent for the PK portion of the study. Additionally, sputum samples will be collected to determine changes in bacterial density. Total Pulmonary Symptom Severity Score (PSSS) will be assessed, and respiratory quality of life will be evaluated by using the St. George's Respiratory Questionnaire (SGRQ). Arikace™,Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and the other studies evaluating amikacin liposome inhalation suspension.
404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.
This study's enrollment of 64 is close to the median of 60 across 263 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Insmed Incorporated is the lead sponsor of 50 studies on the registry; 8 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 8 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this arm of the cohort 1 will receive 280 mg of Arikayce™
Drug: 280 mg Arikayce™
Subjects in this arm of the cohort 1 will receive matching placebo.
Drug: Matching Placebo for Cohort 1
Subjects in this arm of the cohort 2 will receive 560 mg of Arikayce™
Drug: 560 mg Arikayce™
Subjects in this arm of the cohort 2 will receive matching placebo
Drug: Matching Placebo for Cohort 2
Study subjects will receive Arikace™ 280 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
Also known as: liposomal amikacin for inhalation
Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
Study subjects will receive Arikace™ 560 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
Also known as: liposomal amikacin for inhalation
Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Number of Subjects reporting TEAE in the Arikayce™ groups and the placebo groups during the study. The table shows the events incidents, not the number of participants.
Time frame: Day 1 through 56.
Treatment-emergent Marked Laboratory Abnormalities up to 28 Days After Study Medication Discontinuation
Number of subjects reporting Incidence of clinically significant abnormalities in clinical values (Common Terminology Criteria for Adverse Events \[CTCAE\] grade \>= 3) in Arikayce™ and placebo groups.
Time frame: Day 1 through 56.
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Changes in PFT from pre-dose during the study were measured on Days 1, 14, and 28. Acute tolerability of the study treatment was assessed by examining the relative (rel.) changes in FEV1 from pre-dose assessments to 0-1 hour post-dose and 2-4 hours post-dose for each time point at which post-dose spirometry was conducted.
Time frame: Pre-dose, 0-1 hour post-dose and 2-4 hours post-dose on day 1, 0-1 hour post-dose and 2-4 hours post-dose on day 14, and 0-1 hour post-dose and 2-4 hours post-dose on day 28
Treatment-emergent PFT Abnormalities up to the End of Study
Number of Subjects with Decrease of \>= 15% in FEV1 (L) from Pre- to Post-dose by Study Day
Time frame: Day 1, Day 14 and Day 28
Number of Subjects With an Adverse Event Leading to Permanent Discontinuation of Study Medication
Time frame: Screening to Day 56
Serious Adverse Events up to 28 Days After Study Medication Discontinuation
Number of subjects with a SAE in the Arikace™ groups and the placebo group up to 28 days after study medication discontinuation. See SAE table in the safety section for details.
Time frame: Screening to Day 56
Change From Baseline in Log10CFU Per Gram (Density) of Pseudomonas Aeruginosa in Sputum.
The change in Pseudomonas aeruginosa density from from baseline to Day 14, 28, and 42 were evaluated.Treatment differences with respect to the changes from baseline to each measured study day, defined as the log10 of the sum of all morphotypes (colony-forming units \[CFU\]) per gram of sputum in (log10CFU/gram \[g\]), was estimated for each treatment group; standard deviations accompanied the treatment differences.
Time frame: Baseline to Day 14, Day 28 and Day 42.
Total Pulmonary Symptom Severity Score (PSSS)
Changes in the severity and intensity (frequency x severity) of individual symptoms and change in composite PSSS from baseline to Days 14, 28, 42 and 56. The Pulmonary Symptom Severity Score (PSSS) was assessed on patient's responses to the Patients Symptoms Questionnaire, which employs symptom frequency and severity scales described for the validated Memorial Symptoms Assessment Scale. Symptom severity was scored on a scale of 0 (not applicable or symptom not present) to 4 (very severe) for each of the 5 symptoms (cough, shortness of breath, sputum production \[frequency and severity\], fatigue, and wheezing), and a composite score (range, 0 to 20 \[low score represents better outcome\]) was obtained as the sum of the severity scores for each symptom.
Time frame: Baseline to Day 14, Day 28, Day 42 and Day 56.
To Evaluate Change in St. George's Respiratory Questionnaire Measurements
A composite total score is derived as the sum of domain scores for symptoms, activity, and impact, with 0 as the best possible score and 100 as the worst possible score. A reduction in score of 4 points is generally recognized as a clinically meaningful improvement in quality of life. This analysis compared the changes from Day 1 (prior to first dosing) to Days 14, 28, 42, and 56.
Time frame: Day 1 to Day 14, Day 28, Day 42 and Day 56.
To Evaluate the Use of Systemic Antipseudomonal Rescue Therapy
Time frame: Screening to Day 56.
| Milestone | Arikayce™ at 280 mg | Matching Placebo (280 mg) | Arikayce™ at 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Started | 24 | 10 | 20 | 10 |
| Completed | 24 | 10 | 17 | 8 |
| Not completed | 0 | 0 | 3 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 | 2 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 |
Number of Subjects reporting TEAE in the Arikayce™ groups and the placebo groups during the study. The table shows the events incidents, not the number of participants.
| Participants | Arikace™ 280 mg | Matching Placebo (280 mg) | Arikace™ 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Productive Cough | 2 | 3 | 2 | 3 |
| Bronchial disorder | 3 | 0 | 1 | 0 |
| Cough | 1 | 2 | 5 | 0 |
| Haemoptysis | 2 | 1 | 1 | 0 |
| Pyrexia | 2 | 1 | 1 | 2 |
| Wheezing | 1 | 2 | 1 | 0 |
| Dyspnoea | 0 | 2 | 3 | 1 |
| Headache | 1 | 1 | 4 | 1 |
| Nasopharyngitis | 1 | 1 | 1 | 0 |
| Sneezing | 0 | 2 | 0 | 0 |
| Agitation | 1 | 0 | 0 | 0 |
| Aphthous stomatitis | 0 | 1 | 0 | 0 |
| Arthralgia | 1 | 0 | 0 | 0 |
| Cervicobrachial syndrome | 0 | 1 | 0 | 0 |
| Chronic obstructive pulmonary disease | 1 | 0 | 0 | 0 |
| Dizziness | 0 | 1 | 1 | 0 |
| Dysgeusia | 1 | 0 | 0 | 0 |
| Dysphonia | 1 | 0 | 2 | 0 |
| Forced expiratory volume decreased | 1 | 0 | 0 | 0 |
| Pharyngolaryngeal pain | 1 | 0 | 0 | 0 |
| Pruritus | 0 | 1 | 0 | 0 |
| Rash | 0 | 1 | 0 | 0 |
| Rhinorrhoea | 0 | 1 | 0 | 1 |
| Sinus bradycardia | 0 | 1 | 0 | 0 |
| Tinnitus | 1 | 0 | 0 | 0 |
| Toothache | 1 | 0 | 0 | 0 |
| Upper respiratory tract infection | 1 | 0 | 1 | 0 |
| Anorexia | 0 | 0 | 1 | 1 |
| Bronchiectasis | 0 | 0 | 1 | 1 |
| Fatigue | 0 | 0 | 1 | 1 |
| Insomnia | 0 | 0 | 1 | 1 |
| Abortion incomplete | 0 | 0 | 1 | 0 |
| Blood creatinine increased | 0 | 0 | 1 | 0 |
| Constipation | 0 | 0 | 0 | 1 |
| Laryngitis | 0 | 0 | 1 | 0 |
| Lung abscess | 0 | 0 | 0 | 1 |
| Nausea | 0 | 0 | 1 | 0 |
| Palpitations | 0 | 0 | 1 | 0 |
Number of subjects reporting Incidence of clinically significant abnormalities in clinical values (Common Terminology Criteria for Adverse Events \[CTCAE\] grade \>= 3) in Arikayce™ and placebo groups.
| Participants | Arikace™ 280 mg | Matching Placebo (280 mg) | Arikace™ 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Leukocytes | 1 | 0 | 0 | 0 |
| Neutrophils Abs | 4 | 0 | 1 | 0 |
| Sodium | 1 | 0 | 0 | 0 |
| Uric acid | 0 | 1 | 1 | 1 |
Changes in PFT from pre-dose during the study were measured on Days 1, 14, and 28. Acute tolerability of the study treatment was assessed by examining the relative (rel.) changes in FEV1 from pre-dose assessments to 0-1 hour post-dose and 2-4 hours post-dose for each time point at which post-dose spirometry was conducted.
| L | Arikace™ 280 mg | Matching Placebo (280 mg) | Arikace™ 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Day 1: Pre-Dose | 1.917 ± 0.793 | 1.841 ± 0.536 | 1.939 ± 0.515 | 1.758 ± 0.654 |
| Day 1: 0 - 1 Hr Post-Dose | 1.922 ± 0.780 | 1.820 ± 0.546 | 1.907 ± 0.475 | 1.807 ± 0.666 |
| Day 1: 2 - 4 Hrs Post-Dose | 1.955 ± 0.766 | 1.864 ± 0.520 | 1.912 ± 0.477 | 1.812 ± 0.675 |
| Day1:0-1 Hr Post-Dose Rel. Change from Pre-dose | 0.816 ± 9.317 | -1.186 ± 3.028 | -0.873 ± 9.640 | 3.128 ± 12.088 |
| Day1:2-4 Hrs Post-Dose Rel. Change from Pre-dose | 3.323 ± 11.181 | 1.484 ± 3.507 | -0.661 ± 8.374 | 3.082 ± 11.671 |
| Day 14: Pre-Dose | 1.892 ± 0.759 | 1.761 ± 0.550 | 1.864 ± 0.607 | 1.895 ± 0.592 |
| Day 14: 0 - 1 Hr Post-Dose | 1.907 ± 0.776 | 1.794 ± 0.556 | 1.856 ± 0.555 | 1.908 ± 0.611 |
| Day 14: 2 - 4 Hr Post-Dose | 1.931 ± 0.771 | 1.797 ± 0.520 | 1.843 ± 0.567 | 1.901 ± 0.542 |
| Day14:0-1 Hr Post-Dose Rel. Change from Pre-dose | 0.800 ± 8.818 | 2.061 ± 4.509 | -1.629 ± 9.961 | 0.589 ± 4.558 |
| Day14:2-4 Hr Post-Dose Rel. Change from Pre-dose | 2.388 ± 9.020 | 2.711 ± 6.620 | -3.114 ± 8.506 | 1.228 ± 9.617 |
| Day 28: Pre-Dose | 1.919 ± 0.761 | 1.794 ± 0.507 | 1.846 ± 0.532 | 1.934 ± 0.560 |
| Day 28: 0 - 1 Hr Post-Dose | 1.928 ± 0.751 | 1.803 ± 0.502 | 1.797 ± 0.541 | 1.901 ± 0.550 |
| Day 28: 2 - 4 Hrs Post-Dose | 1.908 ± 0.754 | 1.809 ± 0.527 | 1.799 ± 0.578 | 1.940 ± 0.641 |
| Day 28:0-1 Hr Post-Dose Rel. Change from Pre-dose | 0.635 ± 7.647 | 0.654 ± 3.675 | 0.607 ± 4.185 | -1.437 ± 6.454 |
| Day 28:2-4 Hrs Post-Dose Rel. Change from Pre-dose | -0.356 ± 8.858 | 0.601 ± 3.184 | -0.006 ± 6.156 | -0.542 ± 7.690 |
Number of Subjects with Decrease of \>= 15% in FEV1 (L) from Pre- to Post-dose by Study Day
| Participants | Arikace™ 280 mg | Matching Placebo (280 mg) | Arikace™ 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Day 1 — No | 22 | 10 | 17 | 9 |
| Day 1 — Yes | 2 | 0 | 2 | 0 |
| Day 14 — No | 23 | 10 | 18 | 9 |
| Day 14 — Yes | 1 | 0 | 1 | 0 |
| Day 28 — No | 23 | 10 | 19 | 9 |
| Day 28 — Yes | 1 | 0 | 0 | 0 |
| Participants | Arikace™ 280 mg | Matching Placebo (280 mg) | Arikace™ 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Number of Subjects With an Adverse Event Leading to Permanent Discontinuation of Study Medication | 0 | 0 | 1 | 0 |
Number of subjects with a SAE in the Arikace™ groups and the placebo group up to 28 days after study medication discontinuation. See SAE table in the safety section for details.
| Participants | Arikace™ 280 mg | Matching Placebo (280 mg) | Arikace™ 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Serious Adverse Events up to 28 Days After Study Medication Discontinuation | 1 | 0 | 1 | 1 |
The change in Pseudomonas aeruginosa density from from baseline to Day 14, 28, and 42 were evaluated.Treatment differences with respect to the changes from baseline to each measured study day, defined as the log10 of the sum of all morphotypes (colony-forming units \[CFU\]) per gram of sputum in (log10CFU/gram \[g\]), was estimated for each treatment group; standard deviations accompanied the treatment differences.
| log10CFU per gram | Arikace™ 280 mg | Matching Placebo (280 mg) | Arikace™ 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Day 14 Change from Baseline | -0.227 ± 0.805 | -0.333 ± 0.515 | -2.016 ± 1.942 | -0.474 ± 1.942 |
| Day 28 Change from Baseline | -0.094 ± 0.975 | 0.315 ± 0.732 | -1.013 ± 1.099 | -0.302 ± 0.443 |
| Day 42 Change from Baseline | 0.101 ± 0.788 | -0.057 ± 0.627 | 0.046 ± 0.705 | -0.641 ± 1.095 |
Changes in the severity and intensity (frequency x severity) of individual symptoms and change in composite PSSS from baseline to Days 14, 28, 42 and 56. The Pulmonary Symptom Severity Score (PSSS) was assessed on patient's responses to the Patients Symptoms Questionnaire, which employs symptom frequency and severity scales described for the validated Memorial Symptoms Assessment Scale. Symptom severity was scored on a scale of 0 (not applicable or symptom not present) to 4 (very severe) for each of the 5 symptoms (cough, shortness of breath, sputum production \[frequency and severity\], fatigue, and wheezing), and a composite score (range, 0 to 20 \[low score represents better outcome\]) was obtained as the sum of the severity scores for each symptom.
| score on a scale | Arikace™ 280 mg | Matching Placebo (280 mg) | Arikace™ 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Day 14 change from Day 1 | -1.125 ± 2.213 | -0.200 ± 0.789 | -0.471 ± 2.035 | -0.250 ± 2.053 |
| Day 28 change from Day 1 | -2.167 ± 2.988 | 0.000 ± 2.357 | -1.000 ± 4.087 | -0.125 ± 4.257 |
| Day 42 change from Day 1 | -2.458 ± 3.476 | -1.000 ± 1.491 | -1.882 ± 4.285 | 1.125 ± 3.137 |
| Day 56 change from Day 1 | -2.458 ± 2.874 | -1.500 ± 2.121 | -2.167 ± 3.053 | -2.000 ± 1.690 |
A composite total score is derived as the sum of domain scores for symptoms, activity, and impact, with 0 as the best possible score and 100 as the worst possible score. A reduction in score of 4 points is generally recognized as a clinically meaningful improvement in quality of life. This analysis compared the changes from Day 1 (prior to first dosing) to Days 14, 28, 42, and 56.
| score on a scale | Arikace™ 280 mg | Matching Placebo (280 mg) | Arikace™ 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Day 14 change from Day 1 | -4.024 ± 8.558 | -6.350 ± 8.756 | -6.101 ± 12.164 | -2.807 ± 7.256 |
| Day 28 change from Day 1 | -6.205 ± 13.661 | -5.812 ± 12.039 | -6.200 ± 11.855 | -8.304 ± 12.993 |
| Day 42 change from Day 1 | -7.611 ± 13.274 | -6.130 ± 14.271 | -8.196 ± 12.332 | 0.242 ± 5.818 |
| Day 56 change from Day 1 | -7.937 ± 16.281 | -7.371 ± 11.270 | -9.282 ± 10.302 | -1.637 ± 15.161 |
| Participants | Arikace™ 280 mg | Matching Placebo (280mg) | Arikace™ 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Rescue Medication Initiation by Day 28 | 0 | 0 | 0 | 1 |
| Rescue Medication Initiation by Day 56 | 0 | 0 | 0 | 1 |
| No Rescue Medication Initiation | 24 | 10 | 19 | 7 |
Collected over TEAEs were assessed at Baseline and all subsequent study visits up to day 56. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arikace at 280 mg | 0/24 (0%) | 1/24 (4.2%) | 11/24 (45.8%) |
| Matching Placebo (280 mg) | 0/10 (0%) | 0/10 (0%) | 5/10 (50%) |
| Arikace at 560 mg | 0/19 (0%) | 1/19 (5.3%) | 11/19 (57.9%) |
| Matching Placebo (560 mg) | 0/9 (0%) | 1/9 (11.1%) | 6/9 (66.7%) |
| Event | Arikace at 280 mg | Matching Placebo (280 mg) | Arikace at 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Lung AbscessRespiratory, thoracic and mediastinal disorders | 0/24 | 0/10 | 0/19 | 1/9 |
| Abortion IncompletePregnancy, puerperium and perinatal conditions | 0/24 | 0/10 | 1/19 | 0/9 |
| Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders | 1/24 | 0/10 | 0/19 | 0/9 |
| Event | Arikace at 280 mg | Matching Placebo (280 mg) | Arikace at 560 mg | Matching Placebo (560 mg) |
|---|---|---|---|---|
| Productive CoughRespiratory, thoracic and mediastinal disorders | 2/24 | 3/10 | 2/19 | 3/9 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/24 | 2/10 | 5/19 | 0/9 |
| PyrexiaGeneral disorders | 2/24 | 1/10 | 1/19 | 2/9 |
| HeadacheNervous system disorders | 1/24 | 1/10 | 4/19 | 1/9 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/24 | 2/10 | 3/19 | 1/9 |
| WheezingRespiratory, thoracic and mediastinal disorders | 1/24 | 2/10 | 1/19 | 0/9 |
| SneezingRespiratory, thoracic and mediastinal disorders | 0/24 | 2/10 | 0/19 | 1/9 |
| Bronchial DisorderRespiratory, thoracic and mediastinal disorders | 3/24 | 0/10 | 1/19 | 0/9 |
| ConstipationGastrointestinal disorders | 0/24 | 0/10 | 0/19 | 1/9 |
| FatigueGeneral disorders | 0/24 | 0/10 | 1/19 | 1/9 |
Modified intent-to-treat (mITT) population, defined as all randomized patients who received at least 1 dose of study drug.
| Age, Continuous(years) | Arikayce™ at 280 mg | Matching Placebo (280 mg) | Arikayce™ at 560 mg | Matching Placebo (560 mg) | Total |
|---|---|---|---|---|---|
| Mean | 49.9 ± 21.1 | 46.8 ± 15.0 | 58.5 ± 16.0 | 52.3 ± 11.1 | 52.4 ± 17.7 |
| Sex: Female, Male(Participants) | Arikayce™ at 280 mg | Matching Placebo (280 mg) | Arikayce™ at 560 mg | Matching Placebo (560 mg) | Total |
|---|---|---|---|---|---|
| Female | 10 | 4 | 11 | 5 | 30 |
| Male | 14 | 6 | 8 | 4 | 32 |
Ran from Jun 2008 to primary completion in May 2009, 10 months.
Results were first posted in Jul 2019, 10 years 1 month after primary completion. A results delay was requested in Sep 2016.
Of 24 phase 2 interventional studies under Bronchiectasis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 32. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Amikacin