VancomycinHemato-VancoNCT04758442
Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology
A study testing Additional blood sample in people with Vancomycin and Hematologic Malignancies, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
This is a single-center prospective pharmacokinetic study. The principal objective is to collect new data among patients with hematologic cancer to develop a Bayesian population pharmacokinetic model and to improve dose adjustment of intravenous vancomycin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vancomycin, Hematologic Malignancies, Febrile Neutropenia
- What is being tested?
- Additional blood sample
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 31 Oct 2021
- Phase
- Interventional
- 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 diagnosed with a hematologic cancer;
- Subjects hospitalized at Maisonneuve-Rosemont hospital between February 2021 and August 2021;
- Intravenous vancomycin treatment prescribed by a doctor;
- Subjects received at least 3 doses of intravenous vancomycin.
Who cannot join
- Non-malignant diagnosis (aplastic anemia and rare metabolic diseases);
- Subjects admitted to a critical care unit;
- End-stage renal disease (GFR < 15 mL/min/1.73m2);
- Patients undergoing dialysis/renal replacement therapy;
- Acute kidney injury at the moment of the first vancomycin dosage (definition adapted from KDIGO criteria):
- Increase in serum creatinine by ≥ 26.5 umol/L within 48 hours or
Show all 10Show fewer
- Increase in serum creatinine to ≥ 1.5 times baseline within prior 7 days
- Pregnant women;
- Severely burn patients;
- Inability to give free and informed consent.
Trial locations and contacts
1 site in 1 country.
Annie Brisebois-Boyer, Pharm.D, M. Sc contact
Canada1 site, 1 recruiting
- Recruiting
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
About this study
Official title: Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology: a Nomogram Based on a Bayesian Population Model to Predict Initial Dosage of Vancomycin
This is a single-center prospective pharmacokinetic study. The principal objective is to collect new data among patients with hematologic cancer to develop a Bayesian population pharmacokinetic model and to improve dose adjustment of intravenous vancomycin. Approximately 40 subjects meeting the inclusion and no exclusion criteria will be enrolled in the study. Vancomycin blood concentration will be measured at steady-state at three different moment for each participant : immediately before the infusion, 1 hour after the infusion and during the elimination phase (at 3, 4 or 5 hours after the infusion). This additional vancomycin serum concentration in the elimination phase will be used to estimate more precisely the vancomycin pharmacokinetic parameters in this specific population including the distribution volume and the elimination of the molecule. Ultimately, the purpose of this study is to create a nomogram to predict the optimal initial vancomycin dosing in adult patients with a hematologic cancer.
Read the detailed description
STUDY DESIGN:
Prospective, monocentric, pharmacokinetic study.
Adults who have been diagnosed with a hematologic malignancy, are hospitalized at Maisonneuve-Rosemont hospital and received at least 3 doses of intravenous vancomycin.
Pharmacokinetic parameters: Serum vancomycin concentration measured at steady state just before the beginning of the infusion (trough), 1 hour after completion of the infusion (peak) and between 3 to 5 hours after the end of the infusion (additional blood draw during the elimination phase).
RECRUITMENT PROCESS:
A systematic daily screening of hospitalized patients diagnosed with a hematologic cancer will be made by the research team and the pharmacists 7 days a week. An information sheet will be given to all potential eligible patients at their admission. When intravenous vancomycin is prescribed, a member of the research team will explain the study and present the Information and Consent Form (ICF) to the potential participant to obtain his/her official informed consent.
DATA COLLECTION:
Three blood draws will be planned around the fourth or fifth dose of vancomycin and collected by the nursing team. The sampling scheme is as follows: just before the beginning of the infusion (trough), 1 hour after completion of the infusion (peak) and 3, 4 or 5 hours after the end of the infusion (additional blood draw during the elimination phase) according to the assigned time of the participant. The assigned time of the additional blood draw will be randomized at the inclusion of the subject in the study. A member of the research team will provide the tubes to the nurse, will write and save sampling times and will ship the blood samples to the laboratory.
- Conditions
- Vancomycin, Hematologic Malignancies, Febrile Neutropenia
- Being tested
- Additional blood sample
- Keywords
- Bayesian model, Pharmacokinetics
- Medical subject headings
- Hematologic Neoplasms, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional blood sampleOther
Included subjects will provided three blood samples to follow vancomycin concentration
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Experimental | Subjects with hematologic cancer who received intravenous vancomycin for a suspected or confirmed infection. Receives: Other: Additional blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameters : Volume of Distribution
Estimated from vancomycin serum concentrations and patient characteristics
Measured: During intravenous vancomycin treatment assessed to 72 hours
Pharmacokinetic Parameters : Vancomycin clearance
Estimated from vancomycin serum concentrations and patient characteristics
Measured: During intravenous vancomycin treatment assessed to 72 hours
Secondary outcomes (4)
Area Under the concentration-time Curve (AUC)
Measured: between 0 to 24 hours during vancomycin administration
Serum Vancomycin Through Concentration
Vancomycin concentration measured just before the next infusion
Measured: 5 minutes before the selected infusion
Serum Vancomycin Peak Concentration
Vancomycin concentration measured 1 hour after the end of vancomycin infusion
Measured: 60 minutes after the end of the infusion
Serum Vancomycin Elimination Phase Concentration
Vancomycin concentration measured 3 to 5 hours after the end of vancomycin infusion
Measured: 3 to 5 hours after the end of the infusion (+/- 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Feb 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for VancomycinStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758442
- Sponsor's protocol ID
- 2021-2482
- Acronym
- Hemato-Vanco
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Freifeld AG, Bow EJ, Sepkowitz KA, Boeckh MJ, Ito JI, Mullen CA, Raad II, Rolston KV, Young JA, Wingard JR; Infectious Diseases Society of America. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis. 2011 Feb 15;52(4):e56-93. doi: 10.1093/cid/cir073.
PubMed 21258094Wingard JR, Hsu J, Hiemenz JW. Hematopoietic stem cell transplantation: an overview of infection risks and epidemiology. Infect Dis Clin North Am. 2010 Jun;24(2):257-72. doi: 10.1016/j.idc.2010.01.010.
PubMed 20466269Rybak M, Lomaestro B, Rotschafer JC, Moellering R Jr, Craig W, Billeter M, Dalovisio JR, Levine DP. Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2009 Jan 1;66(1):82-98. doi: 10.2146/ajhp080434. No abstract available.
PubMed 19106348Pfizer Canada Inc. PRODUCT MONOGRAPH : VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP. Kirkland, QC Pfizer Canada Inc.;2018.
Rybak MJ. The pharmacokinetic and pharmacodynamic properties of vancomycin. Clin Infect Dis. 2006 Jan 1;42 Suppl 1:S35-9. doi: 10.1086/491712.
PubMed 16323118Zhao W, Zhang D, Fakhoury M, Fahd M, Duquesne F, Storme T, Baruchel A, Jacqz-Aigrain E. Population pharmacokinetics and dosing optimization of vancomycin in children with malignant hematological disease. Antimicrob Agents Chemother. 2014 Jun;58(6):3191-9. doi: 10.1128/AAC.02564-13. Epub 2014 Mar 24.
PubMed 24663023Okada A, Kariya M, Irie K, Okada Y, Hiramoto N, Hashimoto H, Kajioka R, Maruyama C, Kasai H, Hamori M, Nishimura A, Shibata N, Fukushima K, Sugioka N. Population Pharmacokinetics of Vancomycin in Patients Undergoing Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Pharmacol. 2018 Sep;58(9):1140-1149. doi: 10.1002/jcph.1106. Epub 2018 May 15.
PubMed 29762865Aljutayli A, Marsot A, Nekka F. An Update on Population Pharmacokinetic Analyses of Vancomycin, Part I: In Adults. Clin Pharmacokinet. 2020 Jun;59(6):671-698. doi: 10.1007/s40262-020-00866-2.
PubMed 32020531Marsot A, Boulamery A, Bruguerolle B, Simon N. Vancomycin: a review of population pharmacokinetic analyses. Clin Pharmacokinet. 2012 Jan 1;51(1):1-13. doi: 10.2165/11596390-000000000-00000.
PubMed 22149255Neely MN, Youn G, Jones B, Jelliffe RW, Drusano GL, Rodvold KA, Lodise TP. Are vancomycin trough concentrations adequate for optimal dosing? Antimicrob Agents Chemother. 2014;58(1):309-16. doi: 10.1128/AAC.01653-13. Epub 2013 Oct 28.
PubMed 24165176Bury D, Ter Heine R, van de Garde EMW, Nijziel MR, Grouls RJ, Deenen MJ. The effect of neutropenia on the clinical pharmacokinetics of vancomycin in adults. Eur J Clin Pharmacol. 2019 Jul;75(7):921-928. doi: 10.1007/s00228-019-02657-6. Epub 2019 Mar 15.
PubMed 30877327Jarkowski A 3rd, Forrest A, Sweeney RP, Tan W, Segal BH, Almyroudis N, Wang ES, Wetzler M. Characterization of vancomycin pharmacokinetics in the adult acute myeloid leukemia population. J Oncol Pharm Pract. 2012 Mar;18(1):91-6. doi: 10.1177/1078155211402107. Epub 2011 Apr 26.
PubMed 21521799Buelga DS, del Mar Fernandez de Gatta M, Herrera EV, Dominguez-Gil A, Garcia MJ. Population pharmacokinetic analysis of vancomycin in patients with hematological malignancies. Antimicrob Agents Chemother. 2005 Dec;49(12):4934-41. doi: 10.1128/AAC.49.12.4934-4941.2005.
PubMed 16304155Choi MH, Choe YH, Lee SG, Jeong SH, Kim JH. Neutropenia is independently associated with sub-therapeutic serum concentration of vancomycin. Clin Chim Acta. 2017 Feb;465:106-111. doi: 10.1016/j.cca.2016.12.021. Epub 2016 Dec 23.
PubMed 28025029Bosso JA, Nappi J, Rudisill C, Wellein M, Bookstaver PB, Swindler J, Mauldin PD. Relationship between vancomycin trough concentrations and nephrotoxicity: a prospective multicenter trial. Antimicrob Agents Chemother. 2011 Dec;55(12):5475-9. doi: 10.1128/AAC.00168-11. Epub 2011 Sep 26.
PubMed 21947388
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology: a Nomogram Based on a Bayesian Population Model to Predict Initial Dosage of Vancomycin
- ClinicalTrials.gov ID
- NCT04758442
- Acronym / sponsor ID
- Hemato-Vanco / 2021-2482
- Conditions
- Vancomycin, Hematologic Malignancies, Febrile Neutropenia
- Keywords
- Bayesian model, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 17 Feb 2021 (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.
This is a single-center prospective pharmacokinetic study. The principal objective is to collect new data among patients with hematologic cancer to develop a Bayesian population pharmacokinetic model and to improve dose adjustment of intravenous vancomycin. Approximately 40 subjects meeting the inclusion and no exclusion criteria will be enrolled in the study. Vancomycin blood concentration will be measured at steady-state at three different moment for each participant : immediately before the infusion, 1 hour after the infusion and during the elimination phase (at 3, 4 or 5 hours after the infusion). This additional vancomycin serum concentration in the elimination phase will be used to estimate more precisely the vancomycin pharmacokinetic parameters in this specific population including the distribution volume and the elimination of the molecule. Ultimately, the purpose of this study is to create a nomogram to predict the optimal initial vancomycin dosing in adult patients with a hematologic cancer.
Detailed description
STUDY DESIGN:
Prospective, monocentric, pharmacokinetic study.
Adults who have been diagnosed with a hematologic malignancy, are hospitalized at Maisonneuve-Rosemont hospital and received at least 3 doses of intravenous vancomycin.
Pharmacokinetic parameters: Serum vancomycin concentration measured at steady state just before the beginning of the infusion (trough), 1 hour after completion of the infusion (peak) and between 3 to 5 hours after the end of the infusion (additional blood draw during the elimination phase).
RECRUITMENT PROCESS:
A systematic daily screening of hospitalized patients diagnosed with a hematologic cancer will be made by the research team and the pharmacists 7 days a week. An information sheet will be given to all potential eligible patients at their admission. When intravenous vancomycin is prescribed, a member of the research team will explain the study and present the Information and Consent Form (ICF) to the potential participant to obtain his/her official informed consent.
DATA COLLECTION:
Three blood draws will be planned around the fourth or fifth dose of vancomycin and collected by the nursing team. The sampling scheme is as follows: just before the beginning of the infusion (trough), 1 hour after completion of the infusion (peak) and 3, 4 or 5 hours after the end of the infusion (additional blood draw during the elimination phase) according to the assigned time of the participant. The assigned time of the additional blood draw will be randomized at the inclusion of the subject in the study. A member of the research team will provide the tubes to the nurse, will write and save sampling times and will ship the blood samples to the laboratory.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Experimental | Other: Additional blood sampleSubjects with hematologic cancer who received intravenous vancomycin for a suspected or confirmed infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects aged 18 and over;
- Subjects diagnosed with a hematologic cancer;
- Subjects hospitalized at Maisonneuve-Rosemont hospital between February 2021 and August 2021;
- Intravenous vancomycin treatment prescribed by a doctor;
- Subjects received at least 3 doses of intravenous vancomycin.
Key exclusion criteria (10 listed)
- Non-malignant diagnosis (aplastic anemia and rare metabolic diseases);
- Subjects admitted to a critical care unit;
- End-stage renal disease (GFR < 15 mL/min/1.73m2);
- Patients undergoing dialysis/renal replacement therapy;
- Acute kidney injury at the moment of the first vancomycin dosage (definition adapted from KDIGO criteria):
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 |
|---|---|---|
| Additional blood sampleIncluded subjects will provided three blood samples to follow vancomycin concentration | Other | Vancomycin |
Primary outcome
Pharmacokinetic Parameters : Volume of Distribution
Time frame: During intravenous vancomycin treatment assessed to 72 hours
Estimated from vancomycin serum concentrations and patient characteristics
Pharmacokinetic Parameters : Vancomycin clearance
Time frame: During intravenous vancomycin treatment assessed to 72 hours
Estimated from vancomycin serum concentrations and patient characteristics
4 secondary outcomes
Area Under the concentration-time Curve (AUC)
Time frame: between 0 to 24 hours during vancomycin administration
Serum Vancomycin Through Concentration
Time frame: 5 minutes before the selected infusion
Serum Vancomycin Peak Concentration
Time frame: 60 minutes after the end of the infusion
Serum Vancomycin Elimination Phase Concentration
Time frame: 3 to 5 hours after the end of the infusion (+/- 30 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Background: PubMed 21258094Freifeld AG, Bow EJ, Sepkowitz KA, Boeckh MJ, Ito JI, Mullen CA, Raad II, Rolston KV, Young JA, Wingard JR; Infectious Diseases Society of America. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis. 2011 Feb 15;52(4):e56-93. doi: 10.1093/cid/cir073.
- Background: PubMed 20466269Wingard JR, Hsu J, Hiemenz JW. Hematopoietic stem cell transplantation: an overview of infection risks and epidemiology. Infect Dis Clin North Am. 2010 Jun;24(2):257-72. doi: 10.1016/j.idc.2010.01.010.
- Background: PubMed 19106348Rybak M, Lomaestro B, Rotschafer JC, Moellering R Jr, Craig W, Billeter M, Dalovisio JR, Levine DP. Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2009 Jan 1;66(1):82-98. doi: 10.2146/ajhp080434. No abstract available.
- BackgroundPfizer Canada Inc. PRODUCT MONOGRAPH : VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP. Kirkland, QC Pfizer Canada Inc.;2018.
- Background: PubMed 16323118Rybak MJ. The pharmacokinetic and pharmacodynamic properties of vancomycin. Clin Infect Dis. 2006 Jan 1;42 Suppl 1:S35-9. doi: 10.1086/491712.
- Background: PubMed 24663023Zhao W, Zhang D, Fakhoury M, Fahd M, Duquesne F, Storme T, Baruchel A, Jacqz-Aigrain E. Population pharmacokinetics and dosing optimization of vancomycin in children with malignant hematological disease. Antimicrob Agents Chemother. 2014 Jun;58(6):3191-9. doi: 10.1128/AAC.02564-13. Epub 2014 Mar 24.
- Background: PubMed 29762865Okada A, Kariya M, Irie K, Okada Y, Hiramoto N, Hashimoto H, Kajioka R, Maruyama C, Kasai H, Hamori M, Nishimura A, Shibata N, Fukushima K, Sugioka N. Population Pharmacokinetics of Vancomycin in Patients Undergoing Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Pharmacol. 2018 Sep;58(9):1140-1149. doi: 10.1002/jcph.1106. Epub 2018 May 15.
- Background: PubMed 32020531Aljutayli A, Marsot A, Nekka F. An Update on Population Pharmacokinetic Analyses of Vancomycin, Part I: In Adults. Clin Pharmacokinet. 2020 Jun;59(6):671-698. doi: 10.1007/s40262-020-00866-2.
- Background: PubMed 22149255Marsot A, Boulamery A, Bruguerolle B, Simon N. Vancomycin: a review of population pharmacokinetic analyses. Clin Pharmacokinet. 2012 Jan 1;51(1):1-13. doi: 10.2165/11596390-000000000-00000.
- Background: PubMed 24165176Neely MN, Youn G, Jones B, Jelliffe RW, Drusano GL, Rodvold KA, Lodise TP. Are vancomycin trough concentrations adequate for optimal dosing? Antimicrob Agents Chemother. 2014;58(1):309-16. doi: 10.1128/AAC.01653-13. Epub 2013 Oct 28.
- Background: PubMed 30877327Bury D, Ter Heine R, van de Garde EMW, Nijziel MR, Grouls RJ, Deenen MJ. The effect of neutropenia on the clinical pharmacokinetics of vancomycin in adults. Eur J Clin Pharmacol. 2019 Jul;75(7):921-928. doi: 10.1007/s00228-019-02657-6. Epub 2019 Mar 15.
- Background: PubMed 21521799Jarkowski A 3rd, Forrest A, Sweeney RP, Tan W, Segal BH, Almyroudis N, Wang ES, Wetzler M. Characterization of vancomycin pharmacokinetics in the adult acute myeloid leukemia population. J Oncol Pharm Pract. 2012 Mar;18(1):91-6. doi: 10.1177/1078155211402107. Epub 2011 Apr 26.
- 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.
Annie Brisebois-Boyer, Pharm.D, M. Sc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional blood sample in people with Vancomycin and Hematologic Malignancies, run by Ciusss de L'Est de l'Île de Montréal 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie Brisebois-Boyer, Pharm.D, M. Sc (514-252-3400 ext. 1553, abriseboisboyer.hmr@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Parameters : Volume of Distribution (time frame: During intravenous vancomycin treatment assessed to 72 hours). The study lists 2 primary outcomes in all. 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 NCT04758442, which also lists 17 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 17 Feb 2021.