Not yet recruitingNCT07396701CARP-RFUpdated Feb 9, 2026

Chinese Adaptive Randomised Pneumonia Trial With Respiratory Failure

A Phase 4 interventional study of Trendelenburg Position and Traditional Chinese Medicine Formulation in Severe Pneumonia With Respiratory Failure, sponsored by Peking Union Medical College Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 1,500
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

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.

Conditions studied

Severe Pneumonia With Respiratory Failure

In context

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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
Spinal injury
Severe refractory hemodynamic instability.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,500 participants (estimated)

Study arms

No intervention
Receiving standard care alone
Receiving standard care alone
Active comparator
Trendelenburg Position Group
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).
Behavioral: Trendelenburg Position
Active comparator
Traditional Chinese Medicine Formulation
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.
Drug: Traditional Chinese Medicine Formulation

Interventions

BehavioralTrendelenburg Position
Trendelenburg Position: Standard care plus Trendelenburg Position at -10° for ≥12 hours daily until sedation is discontinued and consciousness is recovered (RASS 0).
DrugTraditional Chinese Medicine Formulation
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.

What researchers measure

Primary outcomes

28-day mortality rate
28-day mortality rate
Time frame: 28day

Secondary outcomes

Incidence of Ventilator-Associated Pneumonia (VAP)
Incidence of Ventilator-Associated Pneumonia (VAP)
Time frame: 28days
Ventilator-free days (VFDs) within day 28
Ventilator-free days (VFDs) within day 28
Time frame: 28days
Duration of mechanical ventilation (invasive or non-invasive), days
Duration of mechanical ventilation (invasive or non-invasive), days
Time frame: 28days
Length of Intensive Care Unit (ICU) stay, days
Length of Intensive Care Unit (ICU) stay, days
Time frame: 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: 1. Respiratory System: Based on the PaO₂/FiO₂ ratio (mmHg). 2. Coagulation: Based on platelet count (×10³/µL). 3. Liver: Based on bilirubin level (mg/dL or µmol/L). 4. Cardiovascular System: Based on mean arterial pressure (MAP) or the dose of required vasopressor/inotrope support. 5. Central Nervous System: Based on the Glasgow Coma Scale (GCS) score. 6. Renal System: Based on creatinine level (mg/dL or µmol/L) or urine output.
Time frame: 28days

Study locations

No study locations are listed for this record.

References and documents

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 41177681 ↗
Choi 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 17723807 ↗
Alsharifi 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 39447579 ↗
Li 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 29149418 ↗
Kodamanchili 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 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07396701
Lead sponsor: Peking Union Medical College Hospital
Collaborators: Beijing Hospital of Traditional Chinese Medicine, Beijing Chest Hospital, Shanghai University of Traditional Chinese Medicine, Tianjin University
Responsible party: Sponsor
First posted: Feb 9, 2026
Start date: Feb 20, 2026 (estimated)
Primary completion: Jun 30, 2028 (estimated)
Completion: Dec 31, 2028 (estimated)
Last update: Feb 9, 2026

Study contacts

Li Weng

Contact

wengli@gmail.com

+86 010-6915-6105

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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