Mild to Moderate, Community-Acquired Pneumonia (CAP), Antibiotic Therapy, Intravenous, Hospitalisation
Conditions
Keywords
NRICM102, Community-Acquired Pneumonia (CAP), National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Brief summary
The goal of this clinical trial is to learn if NRICM102 (a Traditional Chinese Medicine) works to treat community-acquired pneumonia (CAP) in adults when added to standard antibiotic therapy. It will also learn about the safety of NRICM102. The main questions it aims to answer are: 1. Does NRICM102 help participants reach clinical stability faster compared to placebo? 2. What medical problems do participants have when taking NRICM102? Researchers will compare NRICM102 to a placebo (a look-alike substance that contains no drug) to see if NRICM102 works as an add-on treatment for community-acquired pneumonia. Participants will: 1. Take NRICM102 or a placebo (2 sachets, 3 times daily) in addition to standard intravenous antibiotic treatment for 7 days 2. Be hospitalized and visited by the study team on Day 1, Day 4, and Day 8 for vital sign monitoring, symptom assessments, laboratory tests, and chest X-ray examinations 3. Be contacted by telephone on Day 30 to check if they were readmitted to the hospital after discharge
Interventions
DRUGNRICM102
1. Name: NRICM102 2. Dosage form: Concentrated granules 3. Unit Content: 5 grams/sachet 4. Dosing schedule: Oral administration, 2 sachets per dose, 3 times daily (total daily dose: 30 grams), for a duration of 7 days 5. Mechanism of action: The main ingredients are believed to inhibit the interaction between the SARS-CoV-2 spike protein and the human angiotensin-converting enzyme 2 (ACE2) receptor, thereby reducing viral entry into host cells. Inhibition of the 3CL protease may suppress viral replication. Additionally, the formulation downregulates inflammatory mediators such as IL-6 and TNF-α, and offers lung protection, anti-fibrotic effects, and potential thrombosis modulation. These properties suggest immunomodulatory and pulmonary protective functions, supporting its use as adjunct therapy in pneumonia. 6. Pharmacological Classification: Traditional Chinese Medicine
DRUGPlacebo
Placebo
Intravenous Antibiotic
Sponsors
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
StatPlus,Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Subjects will receive standard intravenous antibiotic treatment and will be randomly assigned (1:1 ratio) to receive either NRICM102 or placebo for 7 days. The investigational product will be administered orally, 2 sachets (10 g total) three times daily. Subjects whose clinical condition meets the definition of clinical stability for more than 24 hours, and who are deemed stable by the principal investigator, may be transitioned to oral antibiotics or discharged.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged 18 to 85 years 2. The subjects are diagnosed with community-acquired pneumonia (CAP) at the time of hospital admission and must meet all of the following criteria: Chest X-ray showing new onset or persistent pulmonary infiltrate At least two of the following abnormal clinical or laboratory findings: (a) Cough, (b) Sputum production, (c) Fever (≥37.8℃) or hypothermia (\<35℃), (d) Auscultatory findings of rales or bronchial breath sounds, (e) White blood cell count greater than 10×10⁹/L or less than 4×10⁹/L 3. Subjects requiring hospitalization and intravenous antibiotic therapy 4. Subjects who have received standard antibiotic therapy for less than 24 hours after hospital admission 5. Subjects who are able to take the investigational product orally 6. Subjects who are able to understand and comply with all study procedures and provide written informed consent
Exclusion criteria
1. Subjects who have received systemic antibiotic treatment within 72 hours prior to screening; routine antibiotics administered after hospital admission are not included in this restriction 2. Subjects who have used oral traditional Chinese medicine (TCM) or traditional Chinese medicine preparations that may affect efficacy assessment within 7 days prior to hospital admission 3. Subjects who have been hospitalized within 15 days prior to current admission 4. Subjects with aspiration pneumonia 5. Subjects requiring admission to the intensive care unit (ICU) 6. Subjects requiring hemodialysis 7. Subjects with any malignancy, except those who have completed curative treatment with no signs of recurrence for more than five years and require no further anticancer therapy (based on medical history) 8. Subjects with human immunodeficiency virus (HIV) infection 9. Subjects requiring long-term use of non-steroidal anti-inflammatory drugs (NSAIDs), steroids, or other immunosuppressants 10. Subjects requiring antiviral agents for COVID-19 infection or influenza 11. Subjects must be on a stable dose of Omeprazole or Warfarin 12. Subjects with alcohol or substance abuse, or other major organic diseases, such as chronic obstructive pulmonary disease (COPD), asthma, cystic fibrosis, tuberculosis (TB), or significant heart, kidney, or other major organ dysfunction or failure (based on medical history) 13. Female subjects who are pregnant, breastfeeding, or of childbearing potential, or those intending to become pregnant between the signing of the Informed Consent Form (ICF) and the final observation/study time point, or who are unwilling to use an appropriate method of contraception. Acceptable highly effective methods of contraception include: 1. Surgical sterilization (male or female), contraceptive implants, or intrauterine devices (IUDs). 2. Injectable contraceptives, oral contraceptives, contraceptive patches, or vaginal rings, used in combination with one barrier method.\* 3. Combination of two barrier methods.\* \*Effective barrier methods include diaphragms, male or female condoms, contraceptive sponges, or spermicides (creams or gels containing spermicidal chemicals). 14. Subjects deemed unsuitable for study participation by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from initiation of treatment to clinical stability | 30 Days | "Clinical Stability" is defined as the maintenance of all the following criteria for more than 24 consecutive hours: Body Temperature \< 37.8 °C Heart Rate \< 100 beats per minute Respiratory Rate \< 24 breaths per minute Systolic Blood Pressure \> 90 mmHg Blood Oxygen Saturation \> 90% on room air (FiO₂: 21%) Able to Eat Orally Alert |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success rate on Day 4 and Day 8 (Clinical Success) | 8 Days | Assessed symptoms include: cough, sputum production, difficulty breathing, and chest pain Clinical success is defined as improvement in at least two of the four assessed symptoms, with no worsening in any symptom Symptom severity is categorized into four levels (None, Mild, Moderate, Severe). An improvement is defined as a decrease of at least one severity level compared to baseline |
| Subjective assessment of clinical success | 8 Days | Subjective symptoms include: cough, sputum production, difficulty breathing, and chest pain Subjects will rate these symptoms using a Visual Analog Scale (VAS) Symptom assessment is based on the change in score from baseline |
| Improvement rate based on chest X-ray findings | 8 Days | — |
| Rate of hospital readmission within 30 days from the initiation of treatment | 30 Days | — |
| Mortality within 30 days from the initiation of treatment | 30 Days | — |
| ICU admission rate within 30 days from the initiation of treatment | 30 Days | — |
| Time to IV switch from intravenous (IV) to oral antibiotics | 30 Days | — |
| Length of hospitalization | 30 Days | — |
Countries
Taiwan
Outcome results
None listed