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Tobramycin Nebulization to Prevent Multidrug-Resistant Ventilator-Associated Pneumonia (TOP-MDRVAP)

23. september 2026 opdateret af: Second Affiliated Hospital, Zhejiang University, School of Medicine

Tobramycin Nebulization to Prevent Multidrug-Resistant Ventilator-Associated Pneumonia: A Prospective, Multicenter, Double-Blind, Randomized Controlled Trial

The TOP-MDRVAP trial will test whether inhaled tobramycin can safely prevent pneumonia caused by multidrug-resistant bacteria in adults who need a breathing machine. Tobramycin is an antibiotic. Multidrug-resistant bacteria are bacteria that resist treatment with several types of antibiotics. Pneumonia that develops in patients receiving breathing support through a breathing tube is called ventilator-associated pneumonia (VAP). This study will evaluate tobramycin as a preventive treatment, rather than as treatment for existing VAP.

The study plans to enroll 574 adults aged 18 years or older in intensive care units (ICUs) at several hospitals. Participants must have received breathing support through a tube for 72 to 96 hours and be expected to need this support for at least another 72 hours. They must have at least one risk factor for infection with multidrug-resistant bacteria and must not have suspected or confirmed VAP when entering the study.

Participants will be assigned by chance to one of two groups, with an equal chance of entering either group. One group will receive tobramycin inhalation solution, 300 mg in 5 mL, twice daily for 3 consecutive days. The other group will receive 5 mL of 0.9% saline, a saltwater solution containing no antibiotic, on the same schedule. A nebulizer will turn the solution into a fine mist delivered through the breathing tube.

Both groups will receive standard measures to prevent VAP. Participants, their representatives, the healthcare professionals providing their direct care, and the researchers assessing outcomes will not know which study treatment each participant receives.

The main question is whether fewer participants develop VAP caused by multidrug-resistant bacteria within 28 days after assignment to a study group. Researchers will also compare the occurrence of VAP from any cause, antibiotic use, time receiving breathing support, time spent in the ICU and hospital, and deaths within 28 and 90 days.

Participants will be monitored for possible side effects, including kidney problems, narrowing of the airways, and complications involving the breathing tube or equipment. Samples will be tested for bacteria and antibiotic resistance. Follow-up will continue for up to 90 days after assignment, using hospital records or telephone contact to assess survival and recovery milestones, including discharge and the end of breathing support.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Ikke rekrutterer endnu

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
574

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310000
        • Second Affiliated Hospital of Zhejiang University School of Medicine
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age ≥18 years at enrollment.

  2. Invasive mechanical ventilation through an endotracheal tube for ≥72 hours and ≤96 hours, measured from the time of intubation, with an anticipated requirement for at least another 72 hours of invasive mechanical ventilation, as assessed by the attending physician.

  3. At least one of the following risk factors for multidrug-resistant (MDR) bacterial infection:

    3.1 Exposure to systemic antibiotics for ≥24 hours within the 30 days before enrollment.

    3.2 Current hospitalization for at least 120 hours before randomization. 3.3 Septic shock requiring vasoactive medication to maintain a mean arterial pressure ≥65 mmHg, with a blood lactate level >2 mmol/L.

    3.4 Moderate-to-severe acute respiratory distress syndrome (ARDS), according to the Berlin definition, with a PaO2/FiO2 ratio ≤200 mmHg and positive end-expiratory pressure (PEEP) ≥5 cm H2O.

    3.5 Current renal replacement therapy, including continuous renal replacement therapy or intermittent hemodialysis.

    3.6 A history of MDR bacterial colonization or infection within the previous 12 months, documented by clinical culture.

  4. Written informed consent obtained from the patient or the patient's legally authorized representative.

Exclusion Criteria:

  1. Suspected or confirmed ventilator-associated pneumonia (VAP) on the day of enrollment, based on the attending physician's clinical judgment.
  2. Continuous invasive mechanical ventilation for more than 96 hours before enrollment.
  3. Planned extubation within the next 24 hours.
  4. Previous tracheostomy.
  5. A history of allergy to tobramycin or any other aminoglycoside antibiotic.
  6. Use of tobramycin within the 7 days before enrollment; ongoing treatment with any aminoglycoside antibiotic at enrollment; or a clinical indication for intravenous treatment with any aminoglycoside antibiotic at enrollment.
  7. Chronic kidney disease (stages 4-5) with a baseline estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m², or acute kidney injury meeting the protocol-specified Kidney Disease: Improving Global Outcomes (KDIGO) stage 3 criteria: serum creatinine increased to three times baseline, serum creatinine >353.6 μmol/L, urine output <0.3 mL/kg/hour for more than 24 hours, or anuria for more than 12 hours. Patients currently receiving renal replacement therapy are exempt from this renal exclusion criterion.
  8. Expected survival of no more than 48 hours, as assessed by the attending physician.
  9. Pregnancy, indicated by a positive serum or urine human chorionic gonadotropin (hCG) test, or breastfeeding.
  10. Concurrent participation in another interventional clinical study involving nebulized antibiotics or other ventilator-associated pneumonia prevention interventions.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Nebulized Tobramycin

Participants receive tobramycin inhalation solution, 300 mg in 5 mL per dose, administered through the endotracheal tube using a vibrating mesh nebulizer twice daily for 3 consecutive days (6 planned doses). The intervention is administered to prevent multidrug-resistant ventilator-associated pneumonia (MDR-VAP). Participants also receive standard ventilator-associated pneumonia (VAP) prevention measures.
Medicin: Tobramycin inhalation solution

Tobramycin inhalation solution (300 mg/5 mL) is administered at a dose of 300 mg (5 mL) twice daily for 3 consecutive days, for a total of 6 planned doses. The ready-to-use solution is administered without additional dilution through the endotracheal tube using a vibrating mesh nebulizer connected to the ventilator circuit. Each nebulization continues until the nebulizer reservoir is empty. The intervention is administered to prevent multidrug-resistant ventilator-associated pneumonia (MDR-VAP), in addition to standard VAP prevention measures.
Placebo komparator: Nebulized 0.9% Sodium Chloride Placebo

Participants receive 5 mL of 0.9% sodium chloride solution (normal saline) as a placebo, administered through the endotracheal tube using a vibrating mesh nebulizer twice daily for 3 consecutive days (6 planned doses). Participants also receive standard ventilator-associated pneumonia (VAP) prevention measures.
Medicin: 0.9% Sodium Chloride Placebo

A 5 mL dose of 0.9% sodium chloride solution (normal saline) is administered as a placebo twice daily for 3 consecutive days, for a total of 6 planned doses. The solution is delivered through the endotracheal tube using the same type of vibrating mesh nebulizer, administration schedule, and nebulization procedure as the tobramycin intervention. Each nebulization continues until the nebulizer reservoir is empty. Participants also receive standard VAP prevention measures.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
28-Day Cumulative Incidence of Multidrug-Resistant Ventilator-Associated Pneumonia
Tidsramme: From randomization through Day 28.

Percentage of randomized participants with a first episode of multidrug-resistant ventilator-associated pneumonia (MDR-VAP), adjudicated by an independent blinded endpoint adjudication committee. VAP develops after 48 hours of mechanical ventilation, including within 48 hours after weaning or extubation. Diagnosis requires new or progressive infiltrates, consolidation, or ground-glass opacities on chest X-ray or CT plus at least two of: temperature >38°C, purulent airway secretions, and white blood cell count >10 x 10^9/L or <4 x 10^9/L. MDR-VAP additionally requires a positive quantitative lower respiratory tract culture (tracheal aspirate ≥10^5 CFU/mL; bronchoalveolar lavage ≥10^4 CFU/mL; protected specimen brush ≥10^3 CFU/mL) with a causative bacterium resistant to at least three antimicrobial classes.
From randomization through Day 28.

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence Density of Multidrug-Resistant Ventilator-Associated Pneumonia
Tidsramme: From randomization through Day 28.

Number of first episodes of multidrug-resistant ventilator-associated pneumonia per 1,000 invasive mechanical ventilation days accumulated during the assessment period.
From randomization through Day 28.
28-Day Incidence of Ventilator-Associated Pneumonia From Any Cause
Tidsramme: From randomization through Day 28.

28-Day Incidence of Ventilator-Associated Pneumonia From Any Cause
From randomization through Day 28.
Systemic Antibiotic Use Expressed as Antibiotic-Days
Tidsramme: From randomization through Day 28.

Cumulative systemic antibiotic use during the assessment period, expressed as antibiotic-days.
From randomization through Day 28.
Days of Exposure to Systemic Antibiotics
Tidsramme: From randomization through Day 28.

Number of days on which a participant receives at least one systemic antibiotic during the assessment period. Each day with systemic antibiotic exposure is counted once, regardless of the number of antibiotics administered.
From randomization through Day 28.
Duration of Mechanical Ventilation
Tidsramme: From randomization through Day 28.

Total duration of invasive and noninvasive mechanical ventilation, measured in days, during the assessment period.
From randomization through Day 28.
Intensive Care Unit Length of Stay
Tidsramme: From randomization to ICU discharge, assessed up to Day 90.

Duration of intensive care unit stay, measured in days from randomization to ICU discharge, with follow-up through Day 90.
From randomization to ICU discharge, assessed up to Day 90.
Hospital Length of Stay
Tidsramme: From randomization to hospital discharge, assessed up to Day 90.

Duration of hospital stay, measured in days from randomization to hospital discharge, with follow-up through Day 90.
From randomization to hospital discharge, assessed up to Day 90.
28-Day All-Cause Mortality
Tidsramme: From randomization through Day 28.

Percentage of participants who die from any cause within 28 days after randomization.
From randomization through Day 28.
90-Day All-Cause Mortality
Tidsramme: From randomization through Day 90.

Percentage of participants who die from any cause within 90 days after randomization. Survival status is obtained from hospital records or telephone follow-up.
From randomization through Day 90.
Incidence of Ventilator-Associated Pneumonia Caused by Tobramycin-Susceptible Gram-Negative Bacteria
Tidsramme: From randomization through Day 28.

Percentage of participants who develop ventilator-associated pneumonia caused by gram-negative bacteria that are susceptible to tobramycin on in vitro antimicrobial susceptibility testing.
From randomization through Day 28.
Incidence of Ventilator-Associated Events
Tidsramme: From randomization through Day 28.

Percentage of participants who develop a ventilator-associated event, assessed using the protocol-specified 2023 Centers for Disease Control and Prevention/National Healthcare Safety Network definitions. Assessments include ventilator-associated conditions, infection-related ventilator-associated complications, and possible ventilator-associated pneumonia.
From randomization through Day 28.
Incidence of New-Onset Acute Kidney Injury
Tidsramme: From randomization through Day 28.

Percentage of participants without acute kidney injury at baseline who develop Kidney Disease: Improving Global Outcomes (KDIGO) stage 1 or higher acute kidney injury during the assessment period.
From randomization through Day 28.
Daily Trajectory of the Clinical Pulmonary Infection Score
Tidsramme: Assessed daily from randomization until extubation or Day 28, whichever occurs first.

Daily Clinical Pulmonary Infection Score (CPIS) values and their longitudinal changes during the assessment period, calculated using available clinical data.
Assessed daily from randomization until extubation or Day 28, whichever occurs first.
Time to First Successful Spontaneous Breathing Trial
Tidsramme: From randomization through Day 28.

Time, measured in days, from randomization to the first successful spontaneous breathing trial (SBT) during the assessment period.
From randomization through Day 28.
Detection Rate of Tobramycin-Resistant Bacteria
Tidsramme: From randomization through Day 28.

Rate of isolation of tobramycin-resistant bacteria from respiratory specimens or blood cultures during the assessment period.
From randomization through Day 28.
Composite Incidence of Serious Nebulization-Related Adverse Effects
Tidsramme: From randomization through Day 28.

Percentage of participants experiencing at least one serious adverse effect related to nebulization, including increased expiratory filter resistance, bronchospasm, or endotracheal tube obstruction.
From randomization through Day 28.

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Longitudinal Changes in Respiratory Microbiome Alpha Diversity
Tidsramme: Protocol-specified Days 1, 4, 7, and 14, with additional sampling at VAP onset.

Longitudinal changes in respiratory microbiome alpha diversity, assessed by 16S ribosomal RNA amplicon sequencing in participants enrolled in the microbiome substudy.
Protocol-specified Days 1, 4, 7, and 14, with additional sampling at VAP onset.
Longitudinal Changes in Respiratory Microbiome Beta Diversity
Tidsramme: Protocol-specified Days 1, 4, 7, and 14, with additional sampling at VAP onset.

Longitudinal changes in respiratory microbiome beta diversity, assessed by 16S ribosomal RNA amplicon sequencing in participants enrolled in the microbiome substudy.
Protocol-specified Days 1, 4, 7, and 14, with additional sampling at VAP onset.
Longitudinal Changes in Antibiotic Resistance Gene Abundance
Tidsramme: Protocol-specified Days 1, 4, 7, and 14, with additional sampling at VAP onset.

Longitudinal changes in antibiotic resistance gene abundance in respiratory samples, assessed by metagenomic next-generation sequencing.
Protocol-specified Days 1, 4, 7, and 14, with additional sampling at VAP onset.
Longitudinal Changes in Antibiotic Resistance Gene Diversity
Tidsramme: Protocol-specified Days 1, 4, 7, and 14, with additional sampling at VAP onset.

Longitudinal changes in antibiotic resistance gene diversity in respiratory samples, assessed by metagenomic next-generation sequencing.
Protocol-specified Days 1, 4, 7, and 14, with additional sampling at VAP onset.
Tobramycin Concentration-Time Profile in Epithelial Lining Fluid
Tidsramme: During the 3-day study treatment period.

Tobramycin concentrations in epithelial lining fluid over time in participants enrolled in the pharmacokinetic substudy.
During the 3-day study treatment period.
Plasma Tobramycin Concentration-Time Profile
Tidsramme: During the 3-day study treatment period.

Plasma tobramycin concentrations over time in participants enrolled in the pharmacokinetic substudy.
During the 3-day study treatment period.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Second Affiliated Hospital, Zhejiang University, School of Medicine

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
RenJi Hospital
West China Hospital
Qilu Hospital of Shandong University
Ningbo Medical Center Lihuili Hospital
First Affiliated Hospital of Zhejiang University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Jinhua People's Hospital
Second Affiliated Hospital of Wenzhou Medical University
Sir Run Run Shaw Hospital
Zhejiang Provincial People's Hospital
The First People's Hospital of Huzhou
Jinhua Central Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Second Affiliated Hospital of Nanchang University
Taizhou Hospital
People's Hospital of Quzhou
Weifang People's Hospital
Lishui Country People's Hospital
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Zhengzhou Central Hospital
Zhejiang Hospital
Huang Shan People's Hospital
the second people's of kaifeng

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
7. oktober 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
31. oktober 2028

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
29. januar 2029

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
23. september 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
23. september 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
2. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
23. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 2026-0634

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying the results reported in the primary publication of the TOP-MDRVAP trial will be shared, together with a data dictionary. The dataset will include baseline characteristics, treatment allocation, and data supporting the reported efficacy and safety outcomes. Direct identifiers and the participant identification linkage file will not be shared. Data will be made available through controlled access for approved research proposals, subject to participant consent, institutional and ethics requirements, and applicable data-protection regulations.

IPD-delingstidsramme

Data and supporting documents will be available beginning 6 months after publication of the primary trial results and ending 5 years after that publication.

IPD-delingsadgangskriterier

Access will be available to qualified researchers who submit a methodologically sound proposal for secondary analyses or individual participant data meta-analyses. Requests should be submitted to the principal investigator through the study contact listed in the trial registry. The principal investigator and the study Executive Committee will review the scientific merit, feasibility, and data-protection safeguards of each request. Approved applicants must sign a data use agreement limiting use to the approved research, prohibiting participant re-identification and unauthorized onward sharing, and requiring secure data storage. Data will be provided by secure electronic transfer after any required institutional, ethics, or regulatory approvals have been obtained.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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