Ventilator Associated PneumoniaPhase 3REGARD_VAPNCT03382548
Defining Antibiotic Treatment Duration for Ventilator - Associated Lung Infection
A Phase 3 study testing Reducing Antibiotics treatment duration and Standard Antibiotics treatment duration in people with Ventilator Associated Pneumonia and Pneumonia, Bacterial, run by University of Oxford at 7 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Pneumonia, Bacterial
- What is being tested?
- Reducing Antibiotics treatment duration and Standard Antibiotics treatment duration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 21 Feb 2018to 22 Mar 2023
- Phase
- Phase 3
- 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
- Patients 18 years and older
- Invasive mechanical ventilation ≥ 48 hours
- Satisfy the US Centers for Disease Control and Prevention National Healthcare Safety Network VAP diagnostic criteria
- At least one of the following:
- temperature > 38 °C
- white blood cell count ≥ 12,000 cells/mm3 or ≤ 4,000 cells/mm3
Show all 16Show fewer
- altered mental status with no other causes in >70 year-olds; AND
- Two or more chest imaging tests demonstrating at least one of the following:
- new and progressive OR progressive and persistent infiltrate
- new and persistent OR progressive and persistent consolidation
- new and persistent OR progressive and persistent cavitation, AND
- At least two of the following:
- new onset of purulent sputum, or change in character of sputum, or increased respiratory secretions, or increased in suctioning requirements
- new onset or worsening tachypnea or dyspnea
- rales or bronchial breath sounds
- worsening gas exchange defined by oxygen desaturations (e.g., PaO2/FiO2 <240), increased oxygen requirements or increased ventilation demand
Who cannot join
- Poor likelihood of survival as defined by a Sepsis-related Organ Failure Assessment score (SOFA score) of >11 points
- Immunocompromised patients (HIV with CD4 <200 cells/mm3, corticosteroids> 0.5 mg/kg per day for > 30 days, received chemotherapy in the past 3 months, solid organ or hematopoietic cell transplant)
- Patients receiving antibiotic therapy for any other defined extra-pulmonary infections that warrant a duration of antibiotics longer than 7 days, or complications of pneumonia such as lung abscess or empyema, that warrant a duration of antibiotics longer than 7 days (excluding anti-tuberculosis treatment, antifungal medications, antibiotics meant for chronic suppression of chronic infections or chronic obstructive lung disease)
- Patients who have been treated for VAP for more than 7 days from screening
- Vulnerable population including prisoners and refugees
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Thailand3 sites
Khon Kaen Hospital
Khon Kaen
Srinagarind Hospital
Khon Kaen
Sunpasitthiprasong Hospital
Ubon Ratchathani
Nepal2 sites
Civil Hospital
Kathmandu
Patan Academy of Health Science, Patan Hospital, Kathmandu
Patan
Singapore2 sites
National University Hospital, Singapore
Singapore
Tan Tock Seng Hospital
Singapore
About this study
Official title: Reducing Antibiotics Treatment Duration for Ventilator-Associated Pneumonia
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.
Read more
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/
- Being tested
- Reducing Antibiotics treatment duration, Standard Antibiotics treatment duration
- Keywords
- Ventilator Associated Pneumonia, Pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia, Bacterial, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing Antibiotics treatment durationDrug
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.
Standard Antibiotics treatment durationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Short antibiotic treatment duration for VAP (7 days or less) | Active comparator | Not described Receives: Drug: Reducing Antibiotics treatment duration |
| Long antibiotic treatment duration for VAP ( 8 days or more) | Active comparator | Not described Receives: Drug: Standard Antibiotics treatment duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who suffered either death or pneumonia recurrence within 60(±5) days of enrolment
Measured: 60 days
Secondary outcomes (11)
Proportion of patients who suffered ventilator-associated events within 60(±5) days of enrolment
Measured: 60 days
Duration of mechanical ventilation
Measured: 60 days
Duration of hospitalization
Measured: 60 days
Proportion of patients who acquired multidrug resistant infection or colonisation within 60(±5) days of enrolment
Measured: 60 days
Number of days of antibiotics during hospitalization
Measured: From 3 months before to 60 days after enrolment
Number and types of extrapulmonary infections during hospitalisation (determined from cultures taken from sterile sites)
Measured: 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
Measured: 3 years
Relative abundance of the genera in the microbiota between the groups of patients
Measured: 3 years
Route of transmission of MDR Gram-negatives in ICUs by comparing genomic sequencing data
Measured: 3 years
Quality Adjusted Life Years (QALY) loss
Mathematical modeling of antibiotic utilisation and sequencing data to predict outcomes
Measured: 3 years
Financial costs
Mathematical modeling of antibiotic utilisation and sequencing data to predict outcomes
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start21 Feb 2018
- Primary completion23 Jan 2023
- Study completion22 Mar 2023
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 Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation will be done via stratified block randomisation by the study sites to ensure participants with similar characteristics such as gender and age are distributed equally in the intervention and control groups. Randomisation will be done with a computer programme with a seed to allow reproducibility. Randomisation will be done with a 1:1 ratio. To prevent predictability of the random sequence, generation of the randomisation sequence is performed by an independent statistician and details of the randomisation generation is unavailable to all investigators. Randomisation will be allocated using sequentially numbered opaque envelopes. Fitness criteria for randomisation must be met prior to randomisation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Department for International Development, United Kingdom, Mahidol Oxford Tropical Medicine Research Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382548
- Sponsor's protocol ID
- BAC17008
- Acronym
- REGARD_VAP
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2017
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Mo Y, Booraphun S, Li AY, Domthong P, Kayastha G, Lau YH, Chetchotisakd P, Limmathurotsakul D, Tambyah PA, Cooper BS; REGARD-VAP investigators. Individualised, short-course antibiotic treatment versus usual long-course treatment for ventilator-associated pneumonia (REGARD-VAP): a multicentre, individually randomised, open-label, non-inferiority trial. Lancet Respir Med. 2024 May;12(5):399-408. doi: 10.1016/S2213-2600(23)00418-6. Epub 2024 Jan 22.
PubMed 38272050Mo Y, West TE, MacLaren G, Booraphun S, Li AY, Kayastha G, Lau YH, Chew YT, Chetchotisakd P, Tambyah PA, Limmathurotsakul D, Cooper B. Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trial. BMJ Open. 2021 May 13;11(5):e050105. doi: 10.1136/bmjopen-2021-050105.
PubMed 33986070
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Antibiotics Treatment Duration for Ventilator-Associated Pneumonia
- ClinicalTrials.gov ID
- NCT03382548
- Acronym / sponsor ID
- REGARD_VAP / BAC17008
- Keywords
- Ventilator Associated Pneumonia, Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Medical Research Council, Department for International Development, United Kingdom, Mahidol Oxford Tropical Medicine Research Unit
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 26 Dec 2017 (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.
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/
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomisation will be done via stratified block randomisation by the study sites to ensure participants with similar characteristics such as gender and age are distributed equally in the intervention and control groups. Randomisation will be done with a computer programme with a seed to allow reproducibility. Randomisation will be done with a 1:1 ratio. To prevent predictability of the random sequence, generation of the randomisation sequence is performed by an independent statistician and details of the randomisation generation is unavailable to all investigators. Randomisation will be allocated using sequentially numbered opaque envelopes. Fitness criteria for randomisation must be met prior to randomisation.
| Arm | Type | Receives |
|---|---|---|
| Short antibiotic treatment duration for VAP (7 days or less) | Active comparator | Drug: Reducing Antibiotics treatment duration |
| Long antibiotic treatment duration for VAP ( 8 days or more) | Active comparator | Drug: Standard Antibiotics treatment duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients 18 years and older
- Invasive mechanical ventilation ≥ 48 hours
- Satisfy the US Centers for Disease Control and Prevention National Healthcare Safety Network VAP diagnostic criteria
Key exclusion criteria (5 listed)
- Poor likelihood of survival as defined by a Sepsis-related Organ Failure Assessment score (SOFA score) of >11 points
- Immunocompromised patients (HIV with CD4 <200 cells/mm3, corticosteroids> 0.5 mg/kg per day for > 30 days, received chemotherapy in the past 3 months, solid organ or hematopoietic cell transplant)
- Patients receiving antibiotic therapy for any other defined extra-pulmonary infections that warrant a duration of antibiotics longer than 7 days, or complications of pneumonia such as lung abscess or empyema, that warrant a duration of antibiotics longer than 7 days (excluding anti-tuberculosis treatment, antifungal medications, antibiotics meant for chronic suppression of chronic infections or chronic obstructive lung disease)
- Patients who have been treated for VAP for more than 7 days from screening
- Vulnerable population including prisoners and refugees
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 |
|---|---|---|
| Reducing Antibiotics treatment durationAntibiotics 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. | Drug | Short antibiotic treatment duration for VAP (7 days or less) |
| Standard Antibiotics treatment durationParticipants 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. | Drug | Long antibiotic treatment duration for VAP ( 8 days or more) |
Primary outcome
Proportion of patients who suffered either death or pneumonia recurrence within 60(±5) days of enrolment
Time frame: 60 days
11 secondary outcomes
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
Time frame: 3 years
Financial costs
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 38272050Mo Y, Booraphun S, Li AY, Domthong P, Kayastha G, Lau YH, Chetchotisakd P, Limmathurotsakul D, Tambyah PA, Cooper BS; REGARD-VAP investigators. Individualised, short-course antibiotic treatment versus usual long-course treatment for ventilator-associated pneumonia (REGARD-VAP): a multicentre, individually randomised, open-label, non-inferiority trial. Lancet Respir Med. 2024 May;12(5):399-408. doi: 10.1016/S2213-2600(23)00418-6. Epub 2024 Jan 22.
- Derived from this study: PubMed 33986070Mo Y, West TE, MacLaren G, Booraphun S, Li AY, Kayastha G, Lau YH, Chew YT, Chetchotisakd P, Tambyah PA, Limmathurotsakul D, Cooper B. Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trial. BMJ Open. 2021 May 13;11(5):e050105. doi: 10.1136/bmjopen-2021-050105.
- Mo Y, West TE, MacLaren G, et alReducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trialBMJ Open 2021;11:e050105. doi: 10.1136/bmjopen-2021-050105Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reducing Antibiotics treatment duration and Standard Antibiotics treatment duration in people with Ventilator Associated Pneumonia and Pneumonia, Bacterial, run by University of Oxford at 7 sites in 3 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 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Thailand, Nepal, Singapore. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who suffered either death or pneumonia recurrence within 60(±5) days of enrolment (time frame: 60 days). 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 NCT03382548, 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 18 Jan 2024.