A Phase 3 interventional study of Reducing Antibiotics treatment duration and Standard Antibiotics treatment duration in Ventilator Associated Pneumonia and Pneumonia, Bacterial, sponsored by University of Oxford. Completed at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by University of Oxford · Phase 3, Interventional, and Treatment
Among 14 studies in Pneumonia, Ventilator-Associated with a site in Thailand — 1 open to participants now, 1 under way, none of them phase 3. Pneumonia, Ventilator-Associated · Thailand.
Among the 14 studies in Pneumonia, Ventilator-Associated with a site in Thailand, this one is the 2nd largest by enrollment, is one of 2 that started in 2018, is one of 5 in phase 3, and was the 12th registered.
420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 83 are open to participants now.
Browse Pneumonia, Ventilator-Associated studies →1 of the 14 studies in Pneumonia, Ventilator-Associated with a site in Thailand is open now. Recruiting first, the newest first:
National University of Singapore · Sites in Thailand, India, Malaysia and 4 more countries
Ages 18+
A study can be open while its sites in Thailand have not opened yet or have stopped. Only those recruiting at a site in Thailand →
Of the 47 Pneumonia, Ventilator-Associated studies recruiting now, 36 (77%) set no upper age limit and 6 (13%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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14 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2018.
This study's enrollment of 460 is above the median of 115 across 276 interventional studies indexed under Pneumonia, Ventilator-Associated.
Median enrollment 106 across the 14 interventional studies. Of the 13 that completed or were terminated, 5 (38%) have results posted.
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5 of 14 have an industry lead sponsor. The 10 most frequent:
University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
University of Oxford has 1 study filed under Pneumonia, Ventilator-Associated — fewer than ten, so there is no comparison to draw.
1 of the studies in Pneumonia, Ventilator-Associated with a site in Thailand that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05979545National University of SingaporeEaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics | 2027-10-31 |
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Among the 14 studies in Pneumonia, Ventilator-Associated with a site in Thailand, from their registry updates:
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Intensive care units (ICUs), with high antibiotic consumption, are epicentres of antimicrobial resistance (AMR). Ventilator associated pneumonia (VAP) is the commonest hospital-acquired infection (HAI) in ICUs and is associated with a high morbidity and mortality in these vulnerable patients despite antibiotic therapy. No well-designed clinical trials studying antibiotic duration for VAP caused by predominantly non-fermenting Gram-negative bacteria have been conducted to date. Shortening antibiotic duration has the potential to improve individual patient outcomes and indirectly benefit other patients by reducing the selection pressure for multidrug resistant (MDR) bacteria within the ICU.
The study aims to demonstrate clinical non-inferiority-superiority of a short duration of antibiotics (up to 7 days) versus prolonged antibiotic therapy (as per physician preference) in adults with VAP in Asia. Patients who have been ventilated for more than 48 hours will be screened daily for signs and symptoms of VAP according to the US Centers for Disease Control and Prevention VAP criteria. Recruited patients will be reviewed daily for clinical signs of stability including temperature \<38°C for 48 hours, systolic blood pressure >90mmHg without inotropes. Recruited patients will be randomised once they fulfill these clinical criteria of stability. In the intervention arm, antibiotics should be stopped within 7 days once the above criteria are fulfilled. In the control arm, antibiotics should be at least 7 days with the exact duration decided by the managing physicians.
The primary outcome of the study is a combined endpoint of mortality and VAP recurrence at day 60 of recruitment. The study hypothesis is that a shorter duration of treatment for VAP (7 days or less depending on clinical response) is not only noninferior, but may also be superior to a longer duration (8 days or more). The secondary outcomes of the study include clinical parameters such as rate of acquisition of MDRO hospital-acquired infections, duration of ventilation and hospitalization and days of antibiotics use. The study team will also characterise the microbiome changes in study participants according to the type and duration of antibiotics. MDROs collected will undergo whole genome sequencing for transmission dynamics study. The study is a multinational multicenter study involving hospitals in Asia.
Funder: The project will beis partly joinly funded by Medical Research Council/ Department for International Development (MRC/DfID) and Singapore National Medical Research Council (NMRC/CTG).
Grant Ref: MR/K006924/1 and MOH-000470 (MOH-CTGIIT18may-0003)
Conclusions This is a randomised controlled hierarchical non-inferiority-superiority trial being conducted in ICUs across Nepal, Thailand and Singapore. The primary outcome is a composite endpoint of death and pneumonia recurrence at day 60. Secondary outcomes include ventilator-associated events, multidrug-resistant organism infection or colonisation, total duration of antibiotic exposure, mechanical ventilation and hospitalisation. Adult patients who satisfy the US Centers for Disease Control and Prevention National Healthcare Safety Network VAP diagnostic criteria are enrolled. Participants are assessed daily until fever subsides for >48 hours and have stable blood pressure, then randomised to a short duration treatment strategy or a standard-of-care duration arm. Antibiotics may be stopped as early as day 3 if respiratory cultures are negative, and day 5 if respiratory cultures are positive in the short-course arm. Participants receiving standard-of-care will receive antibiotics for at least 8 days. Study participants are followed for 60 days after enrolment. An estimated 460 patients will be required to achieve 80% power to determine non-inferiority with a margin of 12%. All outcomes are compared by absolute risk differences. The conclusion of non-inferiority, and subsequently superiority, will be based on unadjusted and adjusted analyses in both the intention-to-treat and per-protocol populations.
Publication of this study
https://pubmed.ncbi.nlm.nih.gov/33986070/
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Satisfy the US Centers for Disease Control and Prevention National Healthcare Safety Network VAP diagnostic criteria
At least one of the following:
Two or more chest imaging tests demonstrating at least one of the following:
At least two of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Reducing Antibiotics treatment duration
Drug: Standard Antibiotics treatment duration
Antibiotics should be stopped from day 3 to 7 if respiratory cultures are negative and the patients fulfill a set of stringent clinical criteria signifying cardiopulmonary stability for 48 hours. If the respiratory cultures are positive, patients who fulfill the same set of clinical criteria should have their antibiotics stopped from day 5 to 7.
Participants in the control (long duration) arm will receive standard care, which is antibiotic treatment for at least 8 days with the exact duration decided by the primary physician.
Proportion of patients who suffered either death or pneumonia recurrence within 60(±5) days of enrolment
Time frame: 60 days
Proportion of patients who suffered ventilator-associated events within 60(±5) days of enrolment
Time frame: 60 days
Duration of mechanical ventilation
Time frame: 60 days
Duration of hospitalization
Time frame: 60 days
Proportion of patients who acquired multidrug resistant infection or colonisation within 60(±5) days of enrolment
Time frame: 60 days
Number of days of antibiotics during hospitalization
Time frame: From 3 months before to 60 days after enrolment
Number and types of extrapulmonary infections during hospitalisation (determined from cultures taken from sterile sites)
Time frame: 60 days
Characteristics of microbiota in terms of shifts in functional and metabolic capacity by comparing alpha and beta diversity metrics between the groups of patients
Time frame: 3 years
Relative abundance of the genera in the microbiota between the groups of patients
Time frame: 3 years
Route of transmission of MDR Gram-negatives in ICUs by comparing genomic sequencing data
Time frame: 3 years
Quality Adjusted Life Years (QALY) loss
Mathematical modeling of antibiotic utilisation and sequencing data to predict outcomes
Time frame: 3 years
Financial costs
Mathematical modeling of antibiotic utilisation and sequencing data to predict outcomes
Time frame: 3 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The clinical and laboratory data that are stored in our database may be shared with other researchers in the future. However, data will be anonymised and the researchers will not know your identity.
Ran from Feb 2018 to primary completion in Jan 2023, 59 months.
Of 16 phase 3 interventional studies under Pneumonia, Ventilator-Associated, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 59. This study's 59 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Pneumonia, Ventilator-Associated →