Severe Pneumonia With Respiratory FailurePhase 4CARP-RFNCT07396701
Chinese Adaptive Randomised Pneumonia Trial With Respiratory Failure
A Phase 4 study testing Trendelenburg Position and Traditional Chinese Medicine Formulation in people with Severe Pneumonia With Respiratory Failure, run by Peking Union Medical College Hospital.
Trial summary
1. Background Severe pneumonia with respiratory failure carries a high mortality rate. Preliminary evidence suggests potential benefits for interventions such as Trendelenburg Position and certain herbal formulations used within an integrative treatment framework. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Pneumonia With Respiratory Failure
- What is being tested?
- Trendelenburg Position and Traditional Chinese Medicine Formulation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2026to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnancy, terminal illness
- Significant pulmonary fibrosis or lung cancer
- Known/suspected intracranial hypertension
- Increased intraocular pressure or recent eye surgery
- Spinal injury
- Severe refractory hemodynamic instability.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- Background Severe pneumonia with respiratory failure carries a high mortality rate. Preliminary evidence suggests potential benefits for interventions such as Trendelenburg Position and certain herbal formulations used within an integrative treatment framework. However, robust evidence from large-scale trials is lacking. This study utilizes an innovative adaptive platform trial design embedded within a continuous cohort to efficiently evaluate the efficacy and safety of these adjunctive interventions combined with standard care, with the inherent flexibility to incorporate future promising therapies.
- Objectives Primary Objective: To evaluate whether adjunctive treatment with either Trendelenburg Position or Traditional Chinese Medicine (TCM) formulation, compared to standard care alone, reduces all-cause mortality at 28 days in patients with severe pneumonia and respiratory failure. Secondary Objectives: To assess the effects on clinical outcomes including incidence of ventilator-associated pneumonia (VAP), ventilator-free days, duration of mechanical ventilation and ICU stay, Sequential Organ Failure Assessment (SOFA) score trajectory, and oxygenation. To evaluate the safety profile of the interventions.
- Study Design CARP-RF is a Chinese adaptive, randomised trial enrolling patients with pneumonia and respiratory failure. A continuously enrolled master cohort of eligible patients will be established. Within this cohort, eligible consenting participants will be centrally randomized in an unbalanced ratio of (1.5:1:1) to one of three parallel groups.
- Participant Population Inclusion Criteria: Adult patients (≥18 years) admitted to the ICU, diagnosed with severe pneumonia per IDSA/ATS criteria (requiring invasive mechanical ventilation or meeting other major/minor criteria), under invasive mechanical ventilation and sedation (Richmond Agitation-Sedation Scale ≤ -1). Exclusion Criteria: Pregnancy, terminal illness, significant pulmonary fibrosis or lung cancer, known/suspected intracranial hypertension, increased intraocular pressure or recent eye surgery, and severe refractory hemodynamic instability.
- Interventions All participants receive guideline-directed standard care for severe pneumonia. Control Group: Standard care only. Intervention Group 1: Standard care plus Trendelenburg Position at -10° for ≥12 hours daily until sedation is discontinued and consciousness is recovered (RASS 0). Intervention Group 2 (TCM): Standard care plus a complementary TCM strategy prescribed by a licensed TCM practitioner. This includes the use of a tailored herbal formulation (Monarch:Trichosanthes 60g, Rhubarb 15g; Minister: Gypsum 30g, Bitter Apricot Seed 10g, Descurainia Seed 30g, Verbena 60g; Assistant: Glehnia 30g, Adenophora 30g, Astragalus 30g, Ophiopogon 15g, Schisandra 6g; Guide: Licorice 10g). One dose twice daily via oral/enteral route for 7 days.
- Outcome Measures Primary Outcome: All-cause mortality at 28 days after randomization. Key Secondary Outcomes: VAP incidence; Ventilator-free days at 28 days; duration of invasive mechanical ventilation; ICU and hospital length of stay; change in PaO₂/FiO₂ ratio; change in SOFA score.
- Sample Size Approximately 1500 participants will be enrolled from multiple tertiary hospitals in China, accounting for consent rates, eligibility within the cohort, and a 5% attrition rate. The sample provides 80% power (alpha=0.05, two-sided) to detect an absolute mortality reduction from 30% to 20%.
- Randomization, Blinding, and Consent Randomization is performed centrally via an Interactive Web Response System (IWRS), stratified by site and baseline SOFA score. The trial is open-label for caregivers and participants. Outcome assessors and data analysts will be blinded to treatment allocation. A two-stage consent process is used: broad consent for cohort data collection, followed by specific consent for the randomized intervention only for those allocated to an intervention group.
- Data and Safety Monitoring An independent Data and Safety Monitoring Board (DSMB) will periodically review unblinded safety and efficacy data. Serious adverse events will be monitored and reported according to regulatory requirements. The DSMB may recommend protocol modifications, including early stopping for efficacy/futility or incorporation of new interventions into the adaptive platform.
- Statistical Analysis The primary analysis will follow the intention-to-treat principle. Given the pragmatic design, a Compiler Average Causal Effect (CACE) analysis will supplement the primary analysis to estimate the effect among participants who adhere to the protocol. Pre-specified subgroup analyses will be conducted.
- Ethical Considerations The protocol will be approved by the Institutional Review Board of the leading center and all participating sites. The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.
- Being tested
- Trendelenburg Position, Traditional Chinese Medicine Formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trendelenburg PositionBehavioural
Trendelenburg Position: Standard care plus Trendelenburg Position at -10° for ≥12 hours daily until sedation is discontinued and consciousness is recovered (RASS 0).
Traditional Chinese Medicine FormulationDrug
Traditional Chinese Medicine: Standard care plus a complementary TCM strategy prescribed by a licensed TCM practitioner. This includes the use of a tailored herbal formulation (Monarch:Trichosanthes 60g, Rhubarb 15g; Minister: Gypsum 30g, Bitter Apricot Seed 10g, Descurainia Seed 30g, Verbena 60g; Assistant: Glehnia 30g, Adenophora 30g, Astragalus 30g, Ophiopogon 15g, Schisandra 6g; Guide: Licorice 10g) One dose twice daily via oral/enteral route for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Receiving standard care alone | No intervention | Receiving standard care alone |
| Trendelenburg Position Group | Active comparator | Trendelenburg Position: Standard care plus maintenance in the Trendelenburg position at -10° for ≥12 hours daily, continuing until sedation is discontinued and the patient regains consciousness (RASS 0). Receives: Behavioral: Trendelenburg Position |
| Traditional Chinese Medicine Formulation | Active comparator | Traditional Chinese Medicine: Standard care plus a complementary TCM strategy prescribed by a licensed TCM practitioner. This includes the use of a tailored herbal formulation (Monarch:Trichosanthes 60g, Rhubarb 15g; Minister: Gypsum 30g, Bitter Apricot Seed 10g, Descurainia Seed 30g, Verbena 60g; Assistant: Glehnia 30g, Adenophora 30g, Astragalus 30g, Ophiopogon 15g, Schisandra 6g; Guide: Licorice 10g) One dose twice daily via oral/enteral route for 7 days. Receives: Drug: Traditional Chinese Medicine Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality rate
28-day mortality rate
Measured: 28day
Secondary outcomes (5)
Incidence of Ventilator-Associated Pneumonia (VAP)
Incidence of Ventilator-Associated Pneumonia (VAP)
Measured: 28days
Ventilator-free days (VFDs) within day 28
Ventilator-free days (VFDs) within day 28
Measured: 28days
Duration of mechanical ventilation (invasive or non-invasive), days
Duration of mechanical ventilation (invasive or non-invasive), days
Measured: 28days
Length of Intensive Care Unit (ICU) stay, days
Length of Intensive Care Unit (ICU) stay, days
Measured: 28days
Change in Sequential Organ Failure Assessment (SOFA) score
The Sequential Organ Failure Assessment (SOFA) score is a validated tool used to quantify the degree of organ dysfunction in critically ill patients. It assesses six organ systems, each scored from 0 (normal) to 4 (most severe), with a total possible score of 0 to 24. A higher score indicates more severe organ failure.
The components are:
- Respiratory System: Based on the PaO₂/FiO₂ ratio (mmHg).
- Coagulation: Based on platelet count (×10³/µL).
- Liver: Based on bilirubin level (mg/dL or µmol/L).
- Cardiovascular System: Based on mean arterial pressure (MAP) or the dose of required vasopressor/inotrope support.
- Central Nervous System: Based on the Glasgow Coma Scale (GCS) score.
- Renal System: Based on creatinine level (mg/dL or µmol/L) or urine output.
Measured: 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start20 Feb 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Severe Pneumonia With Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital of Traditional Chinese Medicine, Beijing Chest Hospital, Longhua Hospital, Tianjin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396701
- Sponsor's protocol ID
- 2025ZD01903003
- Acronym
- CARP-RF
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu TW, Zhang SW, Jiang H, Yang SW, Guo YJ, Ding MY, Li XC, Xu J, Lu HT, Ye HR, Hu YH, Li R, Wei YM, Song MF, Wang S, Zhang J, Feng QS, Xu XL. Effectiveness of Xuanbai Shengmai Decoction, a compound Chinese herbal medicine, on disease progress and viral RNA shedding in COVID-19 patients: A retrospective study of medical chart in China. J Integr Med. 2026 Jan;24(1):115-124. doi: 10.1016/j.joim.2025.10.001. Epub 2025 Oct 13.
PubMed 41177681Choi YS, Bang SO, Shim JK, Chung KY, Kwak YL, Hong YW. Effects of head-down tilt on intrapulmonary shunt fraction and oxygenation during one-lung ventilation in the lateral decubitus position. J Thorac Cardiovasc Surg. 2007 Sep;134(3):613-8. doi: 10.1016/j.jtcvs.2007.05.018.
PubMed 17723807Alsharifi A, Carter N, Irampaye A, Stevens C, Mejia E, Steier J, Rafferty GF. Ventilatory response to head-down-tilt in healthy human subjects. Exp Physiol. 2024 Dec;109(12):2134-2146. doi: 10.1113/EP092014. Epub 2024 Oct 24.
PubMed 39447579Li Bassi G, Panigada M, Ranzani OT, Zanella A, Berra L, Cressoni M, Parrini V, Kandil H, Salati G, Selvaggi P, Amatu A, Sanz-Moncosi M, Biagioni E, Tagliaferri F, Furia M, Mercurio G, Costa A, Manca T, Lindau S, Babel J, Cavana M, Chiurazzi C, Marti JD, Consonni D, Gattinoni L, Pesenti A, Wiener-Kronish J, Bruschi C, Ballotta A, Salsi P, Livigni S, Iotti G, Fernandez J, Girardis M, Barbagallo M, Moise G, Antonelli M, Caspani ML, Vezzani A, Meybohm P, Gasparovic V, Geat E, Amato M, Niederman M, Kolobow T, Torres A; Gravity-VAP Network. Randomized, multicenter trial of lateral Trendelenburg versus semirecumbent body position for the prevention of ventilator-associated pneumonia. Intensive Care Med. 2017 Nov;43(11):1572-1584. doi: 10.1007/s00134-017-4858-1. Epub 2017 Jun 20.
PubMed 29149418Kodamanchili S, Saigal S, Anand A, Panda R, Priyanka TN, Balakrishnan GT, Bhardwaj K, Shrivatsav P. Trendelenburg Ventilation in Patients of Acute Respiratory Distress Syndrome with Poor Lung Compliance and Diaphragmatic Dysfunction. Indian J Crit Care Med. 2022 Mar;26(3):319-321. doi: 10.5005/jp-journals-10071-24127.
PubMed 35519934
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Adaptive Randomised Pneumonia Trial With Respiratory Failure
- ClinicalTrials.gov ID
- NCT07396701
- Acronym / sponsor ID
- CARP-RF / 2025ZD01903003
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital of Traditional Chinese Medicine, Beijing Chest Hospital, Longhua Hospital, Tianjin University
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Feb 2026 (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.
- Background Severe pneumonia with respiratory failure carries a high mortality rate. Preliminary evidence suggests potential benefits for interventions such as Trendelenburg Position and certain herbal formulations used within an integrative treatment framework. However, robust evidence from large-scale trials is lacking. This study utilizes an innovative adaptive platform trial design embedded within a continuous cohort to efficiently evaluate the efficacy and safety of these adjunctive interventions combined with standard care, with the inherent flexibility to incorporate future promising therapies.
- Objectives Primary Objective: To evaluate whether adjunctive treatment with either Trendelenburg Position or Traditional Chinese Medicine (TCM) formulation, compared to standard care alone, reduces all-cause mortality at 28 days in patients with severe pneumonia and respiratory failure. Secondary Objectives: To assess the effects on clinical outcomes including incidence of ventilator-associated pneumonia (VAP), ventilator-free days, duration of mechanical ventilation and ICU stay, Sequential Organ Failure Assessment (SOFA) score trajectory, and oxygenation. To evaluate the safety profile of the interventions.
- Study Design CARP-RF is a Chinese adaptive, randomised trial enrolling patients with pneumonia and respiratory failure. A continuously enrolled master cohort of eligible patients will be established. Within this cohort, eligible consenting participants will be centrally randomized in an unbalanced ratio of (1.5:1:1) to one of three parallel groups.
- Participant Population Inclusion Criteria: Adult patients (≥18 years) admitted to the ICU, diagnosed with severe pneumonia per IDSA/ATS criteria (requiring invasive mechanical ventilation or meeting other major/minor criteria), under invasive mechanical ventilation and sedation (Richmond Agitation-Sedation Scale ≤ -1). Exclusion Criteria: Pregnancy, terminal illness, significant pulmonary fibrosis or lung cancer, known/suspected intracranial hypertension, increased intraocular pressure or recent eye surgery, and severe refractory hemodynamic instability.
- Interventions All participants receive guideline-directed standard care for severe pneumonia. Control Group: Standard care only. Intervention Group 1: Standard care plus Trendelenburg Position at -10° for ≥12 hours daily until sedation is discontinued and consciousness is recovered (RASS 0). Intervention Group 2 (TCM): Standard care plus a complementary TCM strategy prescribed by a licensed TCM practitioner. This includes the use of a tailored herbal formulation (Monarch:Trichosanthes 60g, Rhubarb 15g; Minister: Gypsum 30g, Bitter Apricot Seed 10g, Descurainia Seed 30g, Verbena 60g; Assistant: Glehnia 30g, Adenophora 30g, Astragalus 30g, Ophiopogon 15g, Schisandra 6g; Guide: Licorice 10g). One dose twice daily via oral/enteral route for 7 days.
- Outcome Measures Primary Outcome: All-cause mortality at 28 days after randomization. Key Secondary Outcomes: VAP incidence; Ventilator-free days at 28 days; duration of invasive mechanical ventilation; ICU and hospital length of stay; change in PaO₂/FiO₂ ratio; change in SOFA score.
- Sample Size Approximately 1500 participants will be enrolled from multiple tertiary hospitals in China, accounting for consent rates, eligibility within the cohort, and a 5% attrition rate. The sample provides 80% power (alpha=0.05, two-sided) to detect an absolute mortality reduction from 30% to 20%.
- Randomization, Blinding, and Consent Randomization is performed centrally via an Interactive Web Response System (IWRS), stratified by site and baseline SOFA score. The trial is open-label for caregivers and participants. Outcome assessors and data analysts will be blinded to treatment allocation. A two-stage consent process is used: broad consent for cohort data collection, followed by specific consent for the randomized intervention only for those allocated to an intervention group.
- Data and Safety Monitoring An independent Data and Safety Monitoring Board (DSMB) will periodically review unblinded safety and efficacy data. Serious adverse events will be monitored and reported according to regulatory requirements. The DSMB may recommend protocol modifications, including early stopping for efficacy/futility or incorporation of new interventions into the adaptive platform.
- Statistical Analysis The primary analysis will follow the intention-to-treat principle. Given the pragmatic design, a Compiler Average Causal Effect (CACE) analysis will supplement the primary analysis to estimate the effect among participants who adhere to the protocol. Pre-specified subgroup analyses will be conducted.
- Ethical Considerations The protocol will be approved by the Institutional Review Board of the leading center and all participating sites. The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Receiving standard care alone | No intervention | –Receiving standard care alone |
| Trendelenburg Position Group | Active comparator | Behavioral: Trendelenburg PositionTrendelenburg Position: Standard care plus maintenance in the Trendelenburg position at -10° for ≥12 hours daily, continuing until sedation is discontinued and the patient regains consciousness (RASS 0). |
| Traditional Chinese Medicine Formulation | Active comparator | Drug: Traditional Chinese Medicine FormulationTraditional Chinese Medicine: Standard care plus a complementary TCM strategy prescribed by a licensed TCM practitioner. This includes the use of a tailored herbal formulation (Monarch:Trichosanthes 60g, Rhubarb 15g; Minister: Gypsum 30g, Bitter Apricot Seed 10g, Descurainia Seed 30g, Verbena 60g; Assistant: Glehnia 30g, Adenophora 30g, Astragalus 30g, Ophiopogon 15g, Schisandra 6g; Guide: Licorice 10g) One dose twice daily via oral/enteral route for 7 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Pregnancy, terminal illness
- Significant pulmonary fibrosis or lung cancer
- Known/suspected intracranial hypertension
- Increased intraocular pressure or recent eye surgery
- Spinal injury
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 |
|---|---|---|
| Trendelenburg PositionTrendelenburg Position: Standard care plus Trendelenburg Position at -10° for ≥12 hours daily until sedation is discontinued and consciousness is recovered (RASS 0). | Behavioural | Trendelenburg Position Group |
| Traditional Chinese Medicine FormulationTraditional Chinese Medicine: Standard care plus a complementary TCM strategy prescribed by a licensed TCM practitioner. This includes the use of a tailored herbal formulation (Monarch:Trichosanthes 60g, Rhubarb 15g; Minister: Gypsum 30g, Bitter Apricot Seed 10g, Descurainia Seed 30g, Verbena 60g; Assistant: Glehnia 30g, Adenophora 30g, Astragalus 30g, Ophiopogon 15g, Schisandra 6g; Guide: Licorice 10g) One dose twice daily via oral/enteral route for 7 days. | Drug | Traditional Chinese Medicine Formulation |
Primary outcome
28-day mortality rate
Time frame: 28day
28-day mortality rate
5 secondary outcomes
Incidence of Ventilator-Associated Pneumonia (VAP)
Time frame: 28days
Ventilator-free days (VFDs) within day 28
Time frame: 28days
Duration of mechanical ventilation (invasive or non-invasive), days
Time frame: 28days
Length of Intensive Care Unit (ICU) stay, days
Time frame: 28days
Change in Sequential Organ Failure Assessment (SOFA) score
Time frame: 28days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background: PubMed 41177681Liu TW, Zhang SW, Jiang H, Yang SW, Guo YJ, Ding MY, Li XC, Xu J, Lu HT, Ye HR, Hu YH, Li R, Wei YM, Song MF, Wang S, Zhang J, Feng QS, Xu XL. Effectiveness of Xuanbai Shengmai Decoction, a compound Chinese herbal medicine, on disease progress and viral RNA shedding in COVID-19 patients: A retrospective study of medical chart in China. J Integr Med. 2026 Jan;24(1):115-124. doi: 10.1016/j.joim.2025.10.001. Epub 2025 Oct 13.
- Background: PubMed 17723807Choi YS, Bang SO, Shim JK, Chung KY, Kwak YL, Hong YW. Effects of head-down tilt on intrapulmonary shunt fraction and oxygenation during one-lung ventilation in the lateral decubitus position. J Thorac Cardiovasc Surg. 2007 Sep;134(3):613-8. doi: 10.1016/j.jtcvs.2007.05.018.
- Background: PubMed 39447579Alsharifi A, Carter N, Irampaye A, Stevens C, Mejia E, Steier J, Rafferty GF. Ventilatory response to head-down-tilt in healthy human subjects. Exp Physiol. 2024 Dec;109(12):2134-2146. doi: 10.1113/EP092014. Epub 2024 Oct 24.
- Background: PubMed 29149418Li Bassi G, Panigada M, Ranzani OT, Zanella A, Berra L, Cressoni M, Parrini V, Kandil H, Salati G, Selvaggi P, Amatu A, Sanz-Moncosi M, Biagioni E, Tagliaferri F, Furia M, Mercurio G, Costa A, Manca T, Lindau S, Babel J, Cavana M, Chiurazzi C, Marti JD, Consonni D, Gattinoni L, Pesenti A, Wiener-Kronish J, Bruschi C, Ballotta A, Salsi P, Livigni S, Iotti G, Fernandez J, Girardis M, Barbagallo M, Moise G, Antonelli M, Caspani ML, Vezzani A, Meybohm P, Gasparovic V, Geat E, Amato M, Niederman M, Kolobow T, Torres A; Gravity-VAP Network. Randomized, multicenter trial of lateral Trendelenburg versus semirecumbent body position for the prevention of ventilator-associated pneumonia. Intensive Care Med. 2017 Nov;43(11):1572-1584. doi: 10.1007/s00134-017-4858-1. Epub 2017 Jun 20.
- Background: PubMed 35519934Kodamanchili S, Saigal S, Anand A, Panda R, Priyanka TN, Balakrishnan GT, Bhardwaj K, Shrivatsav P. Trendelenburg Ventilation in Patients of Acute Respiratory Distress Syndrome with Poor Lung Compliance and Diaphragmatic Dysfunction. Indian J Crit Care Med. 2022 Mar;26(3):319-321. doi: 10.5005/jp-journals-10071-24127.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trendelenburg Position and Traditional Chinese Medicine Formulation in people with Severe Pneumonia With Respiratory Failure, run by Peking Union Medical College Hospital.
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 0 inclusion and 6 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: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Weng (+86 010-6915-6105, wengli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality rate (time frame: 28day). 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 NCT07396701, which also lists 5 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 Feb 2026.