Renal DialysisPhase 1ESRDNCT03904836
Tobramycin Administered at the Beginning of Dialysis
A Phase 1 study testing Tobramycin in people with Renal Dialysis and Renal Failure, Chronic, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate whether the administration of a full tobramycin dose (5 mg/kg) during the first 30 minutes of a hemodialysis session provides favorable pharmacokinetic parameters in subjects with end-stage renal disease who are suspected or has been diagnosed with Gram-negative rod-type… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis, Renal Failure, Chronic
- What is being tested?
- Tobramycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jan 2019to 31 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 and over;
- Subjects with end-stage renal disease who are on an intermittent hemodialysis program (three times a week, 3-4 hours) at the Hôpital Maisonneuve-Rosemont hemodialysis unit for at least one month;
- Subjects with suspicion or diagnosis of Gram-negative rod-type bacteria infection for which an antibiotic is prescribed;
- Subjects able to consent to the study (consent form read and signed by the subject).
Who cannot join
- Contraindication or possible medical hazard related to the administration of tobramycin or to any ingredient in the formulation (e.g. sulphites), such as severe allergies or aminoglycoside-reported previous intolerances;
- Variable residual renal function (e.g. acute or transient renal failure requiring occasional hemodialysis sessions, post-renal transplantation);
- Conditions sensitive to the side effects of tobramycin (e.g. history of myasthenia gravis, Parkinson's disease, vestibular or auditory disorder);
- Subjects with impaired volume of distribution (ie, severe burns [> 20%], significant ascites, decompensation for acute heart failure requiring hospitalization, admission to the critical care unit, cystic fibrosis, morbid obesity [dry weight greater than 50% of ideal weight]);
- Pregnant or breastfeeding women;
- Unstable hemodynamic status (risk of not tolerating / completing a 3-4 hour dialysis session);
Show all 9Show fewer
- Recent treatment with an aminoglycoside (<1 month);
- Participation in another research protocol;
- Inability to give free and informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Tobramycin Administered at the Beginning of Intermittent Hemodialysis Session
The purpose of the study is to evaluate whether the administration of a full tobramycin dose (5 mg/kg) during the first 30 minutes of a hemodialysis session provides favorable pharmacokinetic parameters in subjects with end-stage renal disease who are suspected or has been diagnosed with Gram-negative rod-type infection.
It is anticipated that the administration of a single 5 mg/kg dose of tobramycin during the first 30 minutes of a hemodialysis session will achieve an optimal ratio of maximum tobramycin concentration to minimal inhibitory concentration (Cmax/CMI) of 8 to 10 while limiting the accumulation (trough < 2 mg/L before the next hemodialysis session) in end-stage renal disease subjects requiring intermittent hemodialysis sessions.
Read the detailed description
STUDY DESIGN:
Prospective, monocentric, non-randomized, uncontrolled pharmacokinetic study
End-stage renal disease subjects who have been involved in an intermittent hemodialysis program and who have suspected or diagnosed Gram-negative rod-type infection.
Pharmacokinetic parameters: Tobramycin concentration analyses done at the beginning of hemodialysis session (before tobramycin administration), 30 minutes after completion of the infusion (will allow us to calculate the peak), during hemodialysis session (additional), at the end of hemodialysis session, between hemodialysis sessions (optional) and just before the next hemodialysis session (will allow us to analyse the trough).
RECRUITMENT PROCESS:
A systematic daily screening for hemodialysis hospitalized subjects or subjects followed at the outpatient clinic who have a suspicion or diagnosis of Gram-negative rod type infection will be made by the research coordinators. Software routinely used in the clinic at Maisonneuve-Rosemont Hospital (Gesphar, NumeRx, Oacis and Medurge) will be used to ensure the identification of potential subjects. The pharmacists responsible for validation of prescriptions at the pharmacy department will collaborate with the research team to help identifying eligible candidates. An eligibility assessment tool will be used and subjects who meet the inclusion criteria and do not meet any exclusion criteria will be considered as eligible candidates. Thereafter, additional baseline information will be collected from the medical file (e.g. ethnicity) or by questioning the subject. A member of the research team will addressed the eligible subject, will explain the study and present the Information Form and Informed Consent (FIC), that will document informed consent of the subject.
DATA COLLECTION:
A minimum of four blood samples and a maximum of six blood samples will be collected. The sampling scheme is as follows: at the beginning of hemodialysis session (before tobramycin administration), 30 minutes after completion of the infusion, during hemodialysis session (additional), at the end of hemodialysis session, between hemodialysis sessions (optional) and just before the next hemodialysis session.
A member of the research team will provide the tubes to the nursing, will write sampling times and will ship the blood samples to the laboratory.
STUDY SAMPLE:
Since the objective is to obtain robust pharmacokinetic parameters, the calculation of the sample size aims at a sufficient number of participants to obtain a convergence of facilitated pharmacokinetic parameters, thus obtaining values of coefficients of variation of less than 40%, while maintaining a statistical power of 80%. The calculation uses the variability of the parameters obtained by Veinstein et al. In this study, the residual clearance (Clnhd) is the parameter with the greatest variability (average of 10.4 mL / min with a standard deviation of 6.4 mL / min). Thus, the variability used in calculating the sample size is that of the parameter with the greatest variability, the residual clearance. The sample studied by Veinstein et al. not having the same characteristics as the subjects of the study, the variability could be greater than the reference sample and a safety margin of 30% is added. A total of 12 subjects to be recruited is therefore planned. No correction is applied for losses at the follow-up or withdrawal of consent considering the short duration of the study.
- Conditions
- Renal Dialysis, Renal Failure, Chronic
- Being tested
- Tobramycin
- Keywords
- Chronic Renal Diseases, Kidney Failure, Chronic, Renal Failure, Chronic, Tobramycin, Aminoglycosides, Pharmacokinetics, Infection, Anti-Bacterial Agents, Antibiotics, Renal Insufficiency, Chronic
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TobramycinDrug
5 milligrams per kilogram intravenous for one dose
| Study group | Role | What they receive |
|---|---|---|
| Tobramycin | Experimental | Subjects with end-stage renal disease who have been involved in an intermittent hemodialysis program and who have suspected or diagnosed Gram-negative rod-type infection Receives: Drug: Tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of maximum tobramycin concentration to minimal inhibitory concentration
In subjects receiving a single 5 mg/kg tobramycin dose during the first 30 minutes of a hemodialysis session, to determine the proportion of subjects in whom the maximum concentration is greater than or equal to 8 times that of the minimal inhibitory concentration
Measured: The timeframe for data collection for this outcome is 48 hours to 72 hours
Secondary outcomes (7)
Tobramycin trough level
In subjects receiving a single 5 mg/kg tobramycin dose during the first 30 minutes of a hemodialysis session, to determine the proportion of subjects whose trough concentration of tobramycin is less than or equal to 2 mg / L.
Measured: The timeframe for data collection for this outcome is 48 hours to 72 hours
Residual clearance
Measured: The timeframe for data collection for this outcome is 48 hours to 72 hours
Clearance associated with hemodialysis
Measured: The timeframe for data collection for this outcome is 48 hours to 72 hours
Volume of distribution
Measured: The timeframe for data collection for this outcome is 48 hours to 72 hours
Total area under the curve
Measured: The timeframe for data collection for this outcome is 0 to 48 or 72 hours (depending on time between the two dialysis)
Area under the curve between 0 to 24h after administration
Measured: The timeframe for data collection for this outcome is 0 to 24 hours
Tobramycin concentration
Tobramycin concentration 24h, 48h and 72h after administration
Measured: The timeframe for data collection for this outcome is 24 hours to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start31 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Philippe Lafrance, Maisonneuve-Rosemont Hospital
- Investigators
- Jean-Philippe Lafrance, MD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904836
- Sponsor's protocol ID
- 2019-1619
- Acronym
- ESRD
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cheikh Hassan HI, Tang M, Djurdjev O, Langsford D, Sood MM, Levin A. Infection in advanced chronic kidney disease leads to increased risk of cardiovascular events, end-stage kidney disease and mortality. Kidney Int. 2016 Oct;90(4):897-904. doi: 10.1016/j.kint.2016.07.013. Epub 2016 Aug 31.
PubMed 27591084Kato S, Chmielewski M, Honda H, Pecoits-Filho R, Matsuo S, Yuzawa Y, Tranaeus A, Stenvinkel P, Lindholm B. Aspects of immune dysfunction in end-stage renal disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1526-33. doi: 10.2215/CJN.00950208. Epub 2008 Aug 13.
PubMed 18701615Reynvoet E, Vandijck DM, Blot SI, Dhondt AW, De Waele JJ, Claus S, Buyle FM, Vanholder RC, Hoste EA. Epidemiology of infection in critically ill patients with acute renal failure. Crit Care Med. 2009 Jul;37(7):2203-9. doi: 10.1097/CCM.0b013e3181a03961.
PubMed 19487937Eschenauer GA, Lam SW, Mueller BA. Dose Timing of Aminoglycosides in Hemodialysis Patients: A Pharmacology View. Semin Dial. 2016 May;29(3):204-13. doi: 10.1111/sdi.12458. Epub 2016 Jan 12.
PubMed 26756428Sandoz Canada Inc. Product monograph: Tobramycin injection USP. Boucherville, QC: Sandoz Canada Inc.; 2017.
O'Shea S, Duffull S, Johnson DW. Aminoglycosides in hemodialysis patients: is the current practice of post dialysis dosing appropriate? Semin Dial. 2009 May-Jun;22(3):225-30. doi: 10.1111/j.1525-139X.2008.00554.x. Epub 2009 Apr 5.
PubMed 19386073ANSM. Bon usage des aminosides administrés par voie injectable: gentamicine, tobramycine, netilmicine, amikacine - Mise au point. Paris: National Security Agency of Medicines and Health Products; 2011.
Lacy MK, Nicolau DP, Nightingale CH, Quintiliani R. The pharmacodynamics of aminoglycosides. Clin Infect Dis. 1998 Jul;27(1):23-7. doi: 10.1086/514620.
PubMed 9675444Moore RD, Lietman PS, Smith CR. Clinical response to aminoglycoside therapy: importance of the ratio of peak concentration to minimal inhibitory concentration. J Infect Dis. 1987 Jan;155(1):93-9. doi: 10.1093/infdis/155.1.93.
PubMed 3540140Brummett RE, Morrison RB. The incidence of aminoglycoside antibiotic-induced hearing loss. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):406-10. doi: 10.1001/archotol.1990.01870040028008.
PubMed 2317321Forge A, Schacht J. Aminoglycoside antibiotics. Audiol Neurootol. 2000 Jan-Feb;5(1):3-22. doi: 10.1159/000013861.
PubMed 10686428Gailiunas P Jr, Dominguez-Moreno M, Lazarus M, Lowrie EG, Gottlieb MN, Merrill JP. Vestibular toxicity of gentamicin. Incidence in patients receiving long-term hemodialysis therapy. Arch Intern Med. 1978 Nov;138(11):1621-4. doi: 10.1001/archinte.138.11.1621.
PubMed 309753Halmagyi GM, Fattore CM, Curthoys IS, Wade S. Gentamicin vestibulotoxicity. Otolaryngol Head Neck Surg. 1994 Nov;111(5):571-4. doi: 10.1177/019459989411100506.
PubMed 7970794Ahmed RM, Hannigan IP, MacDougall HG, Chan RC, Halmagyi GM. Gentamicin ototoxicity: a 23-year selected case series of 103 patients. Med J Aust. 2012 Jun 18;196(11):701-4. doi: 10.5694/mja11.10850.
PubMed 22554194Heintz BH, Thompson GR 3rd, Dager WE. Clinical experience with aminoglycosides in dialysis-dependent patients: risk factors for mortality and reassessment of current dosing practices. Ann Pharmacother. 2011 Nov;45(11):1338-45. doi: 10.1345/aph.1Q403. Epub 2011 Oct 18.
PubMed 22010003
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Tobramycin Administered at the Beginning of Intermittent Hemodialysis Session
- ClinicalTrials.gov ID
- NCT03904836
- Acronym / sponsor ID
- ESRD / 2019-1619
- Conditions
- Renal Dialysis, Renal Failure, Chronic
- Keywords
- Chronic Renal Diseases, Kidney Failure, Chronic, Renal Failure, Chronic, Tobramycin, Aminoglycosides, Pharmacokinetics, Infection, Anti-Bacterial Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate whether the administration of a full tobramycin dose (5 mg/kg) during the first 30 minutes of a hemodialysis session provides favorable pharmacokinetic parameters in subjects with end-stage renal disease who are suspected or has been diagnosed with Gram-negative rod-type infection.
It is anticipated that the administration of a single 5 mg/kg dose of tobramycin during the first 30 minutes of a hemodialysis session will achieve an optimal ratio of maximum tobramycin concentration to minimal inhibitory concentration (Cmax/CMI) of 8 to 10 while limiting the accumulation (trough < 2 mg/L before the next hemodialysis session) in end-stage renal disease subjects requiring intermittent hemodialysis sessions.
Detailed description
STUDY DESIGN:
Prospective, monocentric, non-randomized, uncontrolled pharmacokinetic study
End-stage renal disease subjects who have been involved in an intermittent hemodialysis program and who have suspected or diagnosed Gram-negative rod-type infection.
Pharmacokinetic parameters: Tobramycin concentration analyses done at the beginning of hemodialysis session (before tobramycin administration), 30 minutes after completion of the infusion (will allow us to calculate the peak), during hemodialysis session (additional), at the end of hemodialysis session, between hemodialysis sessions (optional) and just before the next hemodialysis session (will allow us to analyse the trough).
RECRUITMENT PROCESS:
A systematic daily screening for hemodialysis hospitalized subjects or subjects followed at the outpatient clinic who have a suspicion or diagnosis of Gram-negative rod type infection will be made by the research coordinators. Software routinely used in the clinic at Maisonneuve-Rosemont Hospital (Gesphar, NumeRx, Oacis and Medurge) will be used to ensure the identification of potential subjects. The pharmacists responsible for validation of prescriptions at the pharmacy department will collaborate with the research team to help identifying eligible candidates. An eligibility assessment tool will be used and subjects who meet the inclusion criteria and do not meet any exclusion criteria will be considered as eligible candidates. Thereafter, additional baseline information will be collected from the medical file (e.g. ethnicity) or by questioning the subject. A member of the research team will addressed the eligible subject, will explain the study and present the Information Form and Informed Consent (FIC), that will document informed consent of the subject.
DATA COLLECTION:
A minimum of four blood samples and a maximum of six blood samples will be collected. The sampling scheme is as follows: at the beginning of hemodialysis session (before tobramycin administration), 30 minutes after completion of the infusion, during hemodialysis session (additional), at the end of hemodialysis session, between hemodialysis sessions (optional) and just before the next hemodialysis session.
A member of the research team will provide the tubes to the nursing, will write sampling times and will ship the blood samples to the laboratory.
STUDY SAMPLE:
Since the objective is to obtain robust pharmacokinetic parameters, the calculation of the sample size aims at a sufficient number of participants to obtain a convergence of facilitated pharmacokinetic parameters, thus obtaining values of coefficients of variation of less than 40%, while maintaining a statistical power of 80%. The calculation uses the variability of the parameters obtained by Veinstein et al. In this study, the residual clearance (Clnhd) is the parameter with the greatest variability (average of 10.4 mL / min with a standard deviation of 6.4 mL / min). Thus, the variability used in calculating the sample size is that of the parameter with the greatest variability, the residual clearance. The sample studied by Veinstein et al. not having the same characteristics as the subjects of the study, the variability could be greater than the reference sample and a safety margin of 30% is added. A total of 12 subjects to be recruited is therefore planned. No correction is applied for losses at the follow-up or withdrawal of consent considering the short duration of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tobramycin | Experimental | Drug: TobramycinSubjects with end-stage renal disease who have been involved in an intermittent hemodialysis program and who have suspected or diagnosed Gram-negative rod-type infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 18 and over;
- Subjects with end-stage renal disease who are on an intermittent hemodialysis program (three times a week, 3-4 hours) at the Hôpital Maisonneuve-Rosemont hemodialysis unit for at least one month;
- Subjects with suspicion or diagnosis of Gram-negative rod-type bacteria infection for which an antibiotic is prescribed;
- Subjects able to consent to the study (consent form read and signed by the subject).
Key exclusion criteria (9 listed)
- Contraindication or possible medical hazard related to the administration of tobramycin or to any ingredient in the formulation (e.g. sulphites), such as severe allergies or aminoglycoside-reported previous intolerances;
- Variable residual renal function (e.g. acute or transient renal failure requiring occasional hemodialysis sessions, post-renal transplantation);
- Conditions sensitive to the side effects of tobramycin (e.g. history of myasthenia gravis, Parkinson's disease, vestibular or auditory disorder);
- Subjects with impaired volume of distribution (ie, severe burns [> 20%], significant ascites, decompensation for acute heart failure requiring hospitalization, admission to the critical care unit, cystic fibrosis, morbid obesity [dry weight greater than 50% of ideal weight]);
- Pregnant or breastfeeding women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobramycin5 milligrams per kilogram intravenous for one dose | Drug | Tobramycin |
Primary outcome
Ratio of maximum tobramycin concentration to minimal inhibitory concentration
Time frame: The timeframe for data collection for this outcome is 48 hours to 72 hours
In subjects receiving a single 5 mg/kg tobramycin dose during the first 30 minutes of a hemodialysis session, to determine the proportion of subjects in whom the maximum concentration is greater than or equal to 8 times that of the minimal inhibitory concentration
7 secondary outcomes
Tobramycin trough level
Time frame: The timeframe for data collection for this outcome is 48 hours to 72 hours
Residual clearance
Time frame: The timeframe for data collection for this outcome is 48 hours to 72 hours
Clearance associated with hemodialysis
Time frame: The timeframe for data collection for this outcome is 48 hours to 72 hours
Volume of distribution
Time frame: The timeframe for data collection for this outcome is 48 hours to 72 hours
Total area under the curve
Time frame: The timeframe for data collection for this outcome is 0 to 48 or 72 hours (depending on time between the two dialysis)
Area under the curve between 0 to 24h after administration
Time frame: The timeframe for data collection for this outcome is 0 to 24 hours
Tobramycin concentration
Time frame: The timeframe for data collection for this outcome is 24 hours to 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Background: PubMed 27591084Cheikh Hassan HI, Tang M, Djurdjev O, Langsford D, Sood MM, Levin A. Infection in advanced chronic kidney disease leads to increased risk of cardiovascular events, end-stage kidney disease and mortality. Kidney Int. 2016 Oct;90(4):897-904. doi: 10.1016/j.kint.2016.07.013. Epub 2016 Aug 31.
- Background: PubMed 18701615Kato S, Chmielewski M, Honda H, Pecoits-Filho R, Matsuo S, Yuzawa Y, Tranaeus A, Stenvinkel P, Lindholm B. Aspects of immune dysfunction in end-stage renal disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1526-33. doi: 10.2215/CJN.00950208. Epub 2008 Aug 13.
- Background: PubMed 19487937Reynvoet E, Vandijck DM, Blot SI, Dhondt AW, De Waele JJ, Claus S, Buyle FM, Vanholder RC, Hoste EA. Epidemiology of infection in critically ill patients with acute renal failure. Crit Care Med. 2009 Jul;37(7):2203-9. doi: 10.1097/CCM.0b013e3181a03961.
- Background: PubMed 26756428Eschenauer GA, Lam SW, Mueller BA. Dose Timing of Aminoglycosides in Hemodialysis Patients: A Pharmacology View. Semin Dial. 2016 May;29(3):204-13. doi: 10.1111/sdi.12458. Epub 2016 Jan 12.
- BackgroundSandoz Canada Inc. Product monograph: Tobramycin injection USP. Boucherville, QC: Sandoz Canada Inc.; 2017.
- Background: PubMed 19386073O'Shea S, Duffull S, Johnson DW. Aminoglycosides in hemodialysis patients: is the current practice of post dialysis dosing appropriate? Semin Dial. 2009 May-Jun;22(3):225-30. doi: 10.1111/j.1525-139X.2008.00554.x. Epub 2009 Apr 5.
- BackgroundANSM. Bon usage des aminosides administrés par voie injectable: gentamicine, tobramycine, netilmicine, amikacine - Mise au point. Paris: National Security Agency of Medicines and Health Products; 2011.
- Background: PubMed 9675444Lacy MK, Nicolau DP, Nightingale CH, Quintiliani R. The pharmacodynamics of aminoglycosides. Clin Infect Dis. 1998 Jul;27(1):23-7. doi: 10.1086/514620.
- Background: PubMed 3540140Moore RD, Lietman PS, Smith CR. Clinical response to aminoglycoside therapy: importance of the ratio of peak concentration to minimal inhibitory concentration. J Infect Dis. 1987 Jan;155(1):93-9. doi: 10.1093/infdis/155.1.93.
- Background: PubMed 2317321Brummett RE, Morrison RB. The incidence of aminoglycoside antibiotic-induced hearing loss. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):406-10. doi: 10.1001/archotol.1990.01870040028008.
- Background: PubMed 10686428Forge A, Schacht J. Aminoglycoside antibiotics. Audiol Neurootol. 2000 Jan-Feb;5(1):3-22. doi: 10.1159/000013861.
- Background: PubMed 309753Gailiunas P Jr, Dominguez-Moreno M, Lazarus M, Lowrie EG, Gottlieb MN, Merrill JP. Vestibular toxicity of gentamicin. Incidence in patients receiving long-term hemodialysis therapy. Arch Intern Med. 1978 Nov;138(11):1621-4. doi: 10.1001/archinte.138.11.1621.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe Lafrance, MD principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tobramycin in people with Renal Dialysis and Renal Failure, Chronic, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of maximum tobramycin concentration to minimal inhibitory concentration (time frame: The timeframe for data collection for this outcome is 48 hours to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03904836, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.