Late Onset Neonatal SepsisPhase 2NeoVancNCT02790996
Neonatal Vancomycin Trial
A Phase 2 study testing Vancomycin in people with Late Onset Neonatal Sepsis, run by PENTA Foundation at 18 sites in 5 countries.
Trial summary
The study aims to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and infants aged ≤ 90 days with late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms Read more about this study
- Who is it for?
- Ages 72 hours to 90 days
- Conditions the study is for
- Late Onset Neonatal Sepsis
- What is being tested?
- Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 27 Feb 2017to 1 Apr 2020
- Phase
- Phase 2
- 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 72 hours to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Postnatal age ≤ 90 days AND
- Postnatal age ≥ 72 hours at onset of sepsis AND
- Clinical sepsis as defined by presence of any three clinical or laboratory criteria from the list below OR
- Confirmed, significant bacterial sepsis as defined by positive culture with a Gram-positive bacterium from a normally sterile site and at least one clinical or one laboratory criterion from the list below, in the 24 hours before randomisation
- Clinical criteria
- hyper- or hypothermia,
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- hypotension or impaired peripheral perfusion or mottled skin,
- apnoea or increased oxygen requirement or increased requirement for ventilatory support,
- bradycardic episodes or tachycardia,
- worsening feeding intolerance or abdominal distension,
- lethargy or hypotonia or irritability
- Laboratory criteria:
- white blood cell (WBC) count < 4 or > 20 x 109 cells/L
- immature to total neutrophil ratio (I/T) > 0.2
- platelet count < 100 x 109/L
- C-reactive protein (CRP) > 10 mg/L
- glucose intolerance as defined by a blood glucose value > 180 mg/dL (> 10 mmol/L) when receiving normal glucose amounts (8 - 15 g/kg/day)
- metabolic acidosis as defined by a base excess (BE) < -10 mmol/L (-10 mEq/L) or a blood lactate value > 2 mmol/L
Who cannot join
- Administration of any systemic antibiotic regimen for more than 24 hours prior to randomisation, unless the change is driven by the apparent lack of efficacy of the original regimen
- Treatment with vancomycin for ≥ 24 hours at any time within 7 days of enrolment
- Known toxicity, hypersensitivity or intolerance to vancomycin
- Known renal impairment with urinary output < 0.7 ml/kg/hour for 24 hours or a creatinine value ≥ 100 µmol/L (1.13 mg/dL)
- Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass
- Severe congenital malformations where the infant is not expected to survive for more than 3 months
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- Patient known to have S. aureus (MSSA or MRSA) bacteraemia
- Patient with osteomyelitis, septic arthritis, urinary tract infection (UTI) or meningitis
- Patient with high suspicion of/confirmed sepsis caused by Gram-negative organisms or fungi
- Other situations where the treating physician considers a different empiric antibiotic regimen necessary
- Current participation in any other clinical study of an investigational medicinal product (IMP)
- Post-randomisation exclusions
- Any participant found to have Gram-negative or fungal sepsis, osteomyelitis, septic arthritis, UTI, meningitis or S. aureus (MSSA or MRSA) bacteraemia after randomisation will be excluded from analysis. Participants who have received at least one dose of study vancomycin will be followed up for safety
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
Greece7 sites
Aghia Sophia Children's Hospital (A)
Athens
Aghia Sophia Children's Hospital (B)
Athens
Aghia Sophia Children's Hospital (C)
Athens
Kyriakou Children's Hospital
Athens
General University Hospital Attikon
Chaïdári
Hippokration Hospital - Department of Neonatology
Thessaloniki
Papageorgiou 2nd Department of Neonatology
Thessaloniki
Italy5 sites
Ospedale "Di Venere" - Carbonara di Bari
Bari
ASST Grande Ospedale Metropolitano Niguarda
Milan
Azienda Ospedaliera di Padova
Padova
Policlinico San Matteo
Pavia
Ospedale Pediatrico Bambino Gesu'
Rome
Spain3 sites
Hospital Sant Joan de Deu
Barcelona
Hospital 12 de Octubre
Madrid
Hospital Materno Infantil, La Paz
Madrid
Estonia2 sites
Tallinn's Children's Hospital
Tallinn
Paediatric Intensive Care Unit, Clinicum of the University of Tartu
Tartu
About this study
Official title: Multi-centre, Randomised, Open Label, Phase IIb Study to Compare the Efficacy, Safety and Pharmacokinetics (PK) of an Optimised Dosing to a Standard Dosing Regimen of Vancomycin in Neonates and Infants Aged ≤ 90 Days With Late Onset Bacterial Sepsis Known or Suspected to be Caused by Gram-positive Microorganisms
The study aims to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and infants aged ≤ 90 days with late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms
Read the detailed description
Detailed objectives of the study are:
- To compare the efficacy of an optimised vancomycin dosing regimen to a standard vancomycin dosing regimen in patients with late onset, bacterial sepsis, known or suspected to be caused by Gram-positive microorganisms.
- To compare the safety of vancomycin (including renal and hearing safety) by allocation group in the intention to treat (ITT) population
- To describe the PK parameters according to vancomycin dosing regimen and outcome using population PK modelling in the ITT population
- To describe PK/PD in terms of the probability of target attainment (PTA) with different vancomycin dosing regimens in the ITT and per protocol (PP) populations
- To describe outcomes and duration of therapy at the end of vancomycin treatment and at the short term follow-up visit by allocation group in the ITT and PP populations
- To compare the clinical outcome to the antibacterial susceptibility of infecting organisms
- To compare colonisation by resistant microorganisms (e.g. vancomycin-resistant enterococci (VRE)) and Candida spp. by allocation group at baseline, TOC and short-term follow-up
- To validate across multiple centres a host biomarker panel to allow improved diagnosis of bacterial sepsis and monitor response to antibacterial therapy
- Conditions
- Late Onset Neonatal Sepsis
- Being tested
- Vancomycin
- Keywords
- sepsis, neonate, vancomycin
- Medical subject headings
- Neonatal Sepsis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Vancomycin is an antibiotic used to treat a number of bacterial infections.It is recommended intravenously as a treatment for complicated skin infections, bloodstream infections, endocarditis, bone and joint infections, and meningitis caused by methicillin-resistant S. aureus.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin - Optimised Regimen | Experimental | A single loading dose of 25 mg/kg followed by a maintenance dose of:
Postmenstrual age ≤ 35 weeks - 15 mg/kg 12 hourly; Postmenstrual age > 35 weeks - 15 mg/kg 8 hourly Receives: Drug: Vancomycin |
| Vancomycin - Standard Regimen | Active comparator | Postmenstrual age < 29 weeks - 15 mg/kg given 24 hourly; Postmenstrual age 29 - 35 weeks - 15 mg/kg 12 hourly; Postmenstrual age > 35 weeks - 15 mg/kg 8 hourly Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful outcome at Test of Cure visit
Patient is alive AND has a successful outcome at the end of actual vancomycin therapy AND the patient has not had a clinically or microbiologically significant relapse or new infection.
Measured: 10±1 days after End of Actual Vancomycin Therapy
Secondary outcomes (11)
Clinically or microbiologically significant relapse or new infection requiring treatment with any other antibiotic for more than 24 hours
Measured: 10±1 days after the End of Actual Vancomycin Treatment
Successful outcome at Visit 4 or End of Actual Vancomycin Therapy including total duration of vancomycin therapy
Measured: Day 5±1 or Day 10±2
Abnormal renal function tests at the Short-term Follow-Up Visit
Measured: 30±5 days post-initiation of vancomycin therapy
Abnormal hearing screening test
Measured: By Day 90 post-initiation of vancomycin therapy
Comparative safety of vancomycin (relating to the number of treatment-related adverse events other than those associated with renal function and hearing) at Short Term Follow-Up Visit
Measured: 30±5 days post-initiation of vancomycin therapy
Pharmacokinetic parameters of vancomycin using population PK modelling by allocation group
Area under the plasma concentration time curve - AUC (mg*hour/L)
Measured: Up to 2 years (final data collection date for outcome measure)
Probability of target attainment (PTA) with different study regimens
Different bacteriological targets will be tested, based on the MIC of different bacteria of interest with level of sensitivity. Simulations based on the vancomycin popPK model will be conducted to define the number of patients in the different allocation groups reaching the predefined targets when modifying the dose.
Measured: Up to 2 years (final data collection date for outcome measure)
Relationship between CoNS species and duration of treatment and CRP response
Measured: Day 5±1 or Day 10±1
Gut colonisation by vancomycin resistant organisms at baseline, Test of Cure Visit and Short-term Follow-Up Visit
Measured: Baseline, 10±1 days after end of vancomycin therapy, 30±5 days post-initiation of vancomycin therapy
Skin colonisation and resistance patterns before and after vancomycin treatment
Measured: Baseline, 10±1 days after end of vancomycin therapy, 30±5 days post-initiation of vancomycin therapy
Assessment of changes in host biomarker panel profiles from baseline to End of Actual Vancomycin Therapy and the relationship between host biomarker and duration of treatment
Functional molecular units based on a multimarker panel - a set of 52 biomarkers will be performed as a classifier with high accuracy and specificity in predicting bacterial infection
Measured: Day 3 and Day 5±1, Day 10±1 (standard arm only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start27 Feb 2017
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: Planned interim analysis yielded different event rate affecting sample size and ability to recruit sufficient numbers within remaining trial time frame
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Late Onset Neonatal SepsisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- PENTA Foundation
- Sponsor type
- Research network
- Collaborators
- St George's, University of London, Hopital Universitaire Robert-Debre, University of Tartu, Consorzio per Valutazioni Biologiche e Farmacologiche, University of Liverpool, Therakind limited, Bambino Gesù Hospital and Research Institute, Servicio Madrileño de Salud, Madrid, Spain, Aristotle University Of Thessaloniki, Cardiff University, SYNAPSE Research Management Partners S.L, European Commission
- Responsible party
- Sponsor
- Investigators
- Mike Sharland, MD, FRCPCH, Study chair, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790996
- Sponsor's protocol ID
- NeoVanc
- Acronym
- NeoVanc
- Status last verified
- Sep 2020
- First submitted
- 7 Apr 2016
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hill LF, Turner MA, Lutsar I, Heath PT, Hardy P, Linsell L, Jacqz-Aigrain E, Roilides E, Sharland M; NeoVanc Consortium. An optimised dosing regimen versus a standard dosing regimen of vancomycin for the treatment of late onset sepsis due to Gram-positive microorganisms in neonates and infants aged less than 90 days (NeoVanc): study protocol for a randomised controlled trial. Trials. 2020 Apr 15;21(1):329. doi: 10.1186/s13063-020-4184-8.
PubMed 32293527Hill LF, Clements MN, Turner MA, Dona D, Lutsar I, Jacqz-Aigrain E, Heath PT, Roilides E, Rawcliffe L, Alonso-Diaz C, Baraldi E, Dotta A, Ilmoja ML, Mahaveer A, Metsvaht T, Mitsiakos G, Papaevangelou V, Sarafidis K, Walker AS, Sharland M; NeoVanc Consortium. Optimised versus standard dosing of vancomycin in infants with Gram-positive sepsis (NeoVanc): a multicentre, randomised, open-label, phase 2b, non-inferiority trial. Lancet Child Adolesc Health. 2022 Jan;6(1):49-59. doi: 10.1016/S2352-4642(21)00305-9. Epub 2021 Nov 26.
PubMed 34843669
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Randomised, Open Label, Phase IIb Study to Compare the Efficacy, Safety and Pharmacokinetics (PK) of an Optimised Dosing to a Standard Dosing Regimen of Vancomycin in Neonates and Infants Aged ≤ 90 Days With Late Onset Bacterial Sepsis Known or Suspected to be Caused by Gram-positive Microorganisms
- ClinicalTrials.gov ID
- NCT02790996
- Acronym / sponsor ID
- NeoVanc / NeoVanc
- Conditions
- Late Onset Neonatal Sepsis
- Keywords
- sepsis, neonate, vancomycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Planned interim analysis yielded different event rate affecting sample size and ability to recruit sufficient numbers within remaining trial time frame
- Enrolment
- 242 participants (actual)
- Lead sponsor
- PENTA FoundationResearch network
- Collaborators
- St George's, University of London, Hopital Universitaire Robert-Debre, University of Tartu, Consorzio per Valutazioni Biologiche e Farmacologiche, University of Liverpool, Therakind limited, Bambino Gesù Hospital and Research Institute, Servicio Madrileño de Salud, Madrid, Spain, Aristotle University Of Thessaloniki, Cardiff University, SYNAPSE Research Management Partners S.L, European Commission
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 6 Jun 2016 (estimated)
- 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 study aims to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and infants aged ≤ 90 days with late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms
Detailed description
Detailed objectives of the study are:
- To compare the efficacy of an optimised vancomycin dosing regimen to a standard vancomycin dosing regimen in patients with late onset, bacterial sepsis, known or suspected to be caused by Gram-positive microorganisms.
- To compare the safety of vancomycin (including renal and hearing safety) by allocation group in the intention to treat (ITT) population
- To describe the PK parameters according to vancomycin dosing regimen and outcome using population PK modelling in the ITT population
- To describe PK/PD in terms of the probability of target attainment (PTA) with different vancomycin dosing regimens in the ITT and per protocol (PP) populations
- To describe outcomes and duration of therapy at the end of vancomycin treatment and at the short term follow-up visit by allocation group in the ITT and PP populations
- To compare the clinical outcome to the antibacterial susceptibility of infecting organisms
- To compare colonisation by resistant microorganisms (e.g. vancomycin-resistant enterococci (VRE)) and Candida spp. by allocation group at baseline, TOC and short-term follow-up
- To validate across multiple centres a host biomarker panel to allow improved diagnosis of bacterial sepsis and monitor response to antibacterial therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin - Optimised Regimen | Experimental | Drug: VancomycinA single loading dose of 25 mg/kg followed by a maintenance dose of: Postmenstrual age ≤ 35 weeks - 15 mg/kg 12 hourly; Postmenstrual age > 35 weeks - 15 mg/kg 8 hourly |
| Vancomycin - Standard Regimen | Active comparator | Drug: VancomycinPostmenstrual age < 29 weeks - 15 mg/kg given 24 hourly; Postmenstrual age 29 - 35 weeks - 15 mg/kg 12 hourly; Postmenstrual age > 35 weeks - 15 mg/kg 8 hourly |
Who may qualify
- Ages
- 72 hours to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Postnatal age ≤ 90 days AND
- Postnatal age ≥ 72 hours at onset of sepsis AND
- Clinical sepsis as defined by presence of any three clinical or laboratory criteria from the list below OR
- Confirmed, significant bacterial sepsis as defined by positive culture with a Gram-positive bacterium from a normally sterile site and at least one clinical or one laboratory criterion from the list below, in the 24 hours before randomisation
- Clinical criteria
Key exclusion criteria (13 listed)
- Administration of any systemic antibiotic regimen for more than 24 hours prior to randomisation, unless the change is driven by the apparent lack of efficacy of the original regimen
- Treatment with vancomycin for ≥ 24 hours at any time within 7 days of enrolment
- Known toxicity, hypersensitivity or intolerance to vancomycin
- Known renal impairment with urinary output < 0.7 ml/kg/hour for 24 hours or a creatinine value ≥ 100 µmol/L (1.13 mg/dL)
- Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass
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 |
|---|---|---|
| VancomycinVancomycin is an antibiotic used to treat a number of bacterial infections.It is recommended intravenously as a treatment for complicated skin infections, bloodstream infections, endocarditis, bone and joint infections, and meningitis caused by methicillin-resistant S. aureus. | Drug | Vancomycin - Optimised Regimen, Vancomycin - Standard Regimen |
Primary outcome
Successful outcome at Test of Cure visit
Time frame: 10±1 days after End of Actual Vancomycin Therapy
Patient is alive AND has a successful outcome at the end of actual vancomycin therapy AND the patient has not had a clinically or microbiologically significant relapse or new infection.
11 secondary outcomes
Clinically or microbiologically significant relapse or new infection requiring treatment with any other antibiotic for more than 24 hours
Time frame: 10±1 days after the End of Actual Vancomycin Treatment
Successful outcome at Visit 4 or End of Actual Vancomycin Therapy including total duration of vancomycin therapy
Time frame: Day 5±1 or Day 10±2
Abnormal renal function tests at the Short-term Follow-Up Visit
Time frame: 30±5 days post-initiation of vancomycin therapy
Abnormal hearing screening test
Time frame: By Day 90 post-initiation of vancomycin therapy
Comparative safety of vancomycin (relating to the number of treatment-related adverse events other than those associated with renal function and hearing) at Short Term Follow-Up Visit
Time frame: 30±5 days post-initiation of vancomycin therapy
Pharmacokinetic parameters of vancomycin using population PK modelling by allocation group
Time frame: Up to 2 years (final data collection date for outcome measure)
Probability of target attainment (PTA) with different study regimens
Time frame: Up to 2 years (final data collection date for outcome measure)
Relationship between CoNS species and duration of treatment and CRP response
Time frame: Day 5±1 or Day 10±1
Gut colonisation by vancomycin resistant organisms at baseline, Test of Cure Visit and Short-term Follow-Up Visit
Time frame: Baseline, 10±1 days after end of vancomycin therapy, 30±5 days post-initiation of vancomycin therapy
Skin colonisation and resistance patterns before and after vancomycin treatment
Time frame: Baseline, 10±1 days after end of vancomycin therapy, 30±5 days post-initiation of vancomycin therapy
Assessment of changes in host biomarker panel profiles from baseline to End of Actual Vancomycin Therapy and the relationship between host biomarker and duration of treatment
Time frame: Day 3 and Day 5±1, Day 10±1 (standard arm only)
Results and safety
The study was stopped early (reason given: Planned interim analysis yielded different event rate affecting sample size and ability to recruit sufficient numbers within remaining trial time frame). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 32293527Hill LF, Turner MA, Lutsar I, Heath PT, Hardy P, Linsell L, Jacqz-Aigrain E, Roilides E, Sharland M; NeoVanc Consortium. An optimised dosing regimen versus a standard dosing regimen of vancomycin for the treatment of late onset sepsis due to Gram-positive microorganisms in neonates and infants aged less than 90 days (NeoVanc): study protocol for a randomised controlled trial. Trials. 2020 Apr 15;21(1):329. doi: 10.1186/s13063-020-4184-8.
- Derived from this study: PubMed 34843669Hill LF, Clements MN, Turner MA, Dona D, Lutsar I, Jacqz-Aigrain E, Heath PT, Roilides E, Rawcliffe L, Alonso-Diaz C, Baraldi E, Dotta A, Ilmoja ML, Mahaveer A, Metsvaht T, Mitsiakos G, Papaevangelou V, Sarafidis K, Walker AS, Sharland M; NeoVanc Consortium. Optimised versus standard dosing of vancomycin in infants with Gram-positive sepsis (NeoVanc): a multicentre, randomised, open-label, phase 2b, non-inferiority trial. Lancet Child Adolesc Health. 2022 Jan;6(1):49-59. doi: 10.1016/S2352-4642(21)00305-9. Epub 2021 Nov 26.
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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.
Mike Sharland, MD, FRCPCH study chair
St George's, University of London
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vancomycin in people with Late Onset Neonatal Sepsis, run by PENTA Foundation at 18 sites in 5 countries.
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 18 inclusion and 13 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: stopped early, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Greece, Italy, Spain, Estonia, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Planned interim analysis yielded different event rate affecting sample size and ability to recruit sufficient numbers within remaining trial time frame). Results are not available in the source record.
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?
Successful outcome at Test of Cure visit (time frame: 10±1 days after End of Actual Vancomycin Therapy). 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 NCT02790996, which also lists 2 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 9 Sep 2020.