Community Acquired PneumoniaPhase 4NCT02913118
Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia
A Phase 4 study testing Andrographolid Sulfonate Injection (AS Injection), Cephalosporin and Azithromycin, Minocycline or Doxycycline in people with Community Acquired Pneumonia, run by Qingfeng Pharmaceutical Group at 16 sites in China.
Trial summary
Adjunctive Therapy of AndrographolidSulfonate in Community Acquired Pneumonia: A Multicenter, Randomized,Double-blinded, Placebo Controlled Clinical Trial. The hypothesis is that combination therapy with Andrographolid Sulfonatein injection and antibacterial is significantly better than antibacterial alone in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- Andrographolid Sulfonate Injection (AS Injection), Cephalosporin and Azithromycin, Minocycline or Doxycycline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 462 participants
- Where
- 16 sitesChina
- Study dates
- Jul 2016to 30 Jun 2019
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18-75 years, no gender restrictions.
- Voluntary participation, all participants provide written informed consent.
- Volunteers are hospitalized patients
- Patients are hospitalized for community acquired pneumonia with T≥38°C within 24 hours before being enrolled Diagnosis of CAP(Chinese Guideline for Diagnosis and Management of Community Acquired Pneumonia in Adults 2016)
- Pneumonia that is acquired in community
- Symptoms and signs of pneumonia:
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- Presence of cough, expectoration or exacerbation of chronic airways disease, with or without purulent sputum/chest pain/dyspnea/hemoptysis.
- Presence offever.
- Lung consolidation and/or moist rales.
- Peripheral blood（WBC）>10×109/L or <4×109/L, with or without nuclear left shift; 3. Chest radiograph shows new ground-glass opacity, patchy infiltration, consolidation or interstitial changes, with or without pleural effusion.
- Patients who meet 1,3 and any one item in 2, exclude one of the following are clinically classified as CAP: pulmonary tuberculosis, cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophilia and pulmonary vasculitis.
- CURB 65≥1 point,Each risk factor scores one point, for a maximum score of 5:
- Confusion of new onset
- Blood Urea nitrogen greater than 7 mmol/l (19 mg/dL)
- Respiratory rate of 30 breaths per minute or greater
- Blood pressure less than 90 mmHg systolic or diastolic blood pressure 60 mmHg or less
- Age 65 or older
- Within 72 hours after symptom onset
Who cannot join
- Known allergy to AS
- Pregnant or breast-feeding
- Heart dysfunction, NYHA III-IV class
- Hematological system diseases, such as lymphoma, leukemia, agranulocytosis (neutrophil count< 0.5×109/L).
- Autoimmune diseases and disease active
- Terminal malignant tumor
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- Long-term treatment of high dose corticosteroids (prednisone 10mg/d ≥2 weeks) or immunosuppressive agents
- Inflammatory bowel disease, such as Crohn's disease, ulcerative colitis
- Chronic renal failure, eGFR<50 ml/min/1.73m2
- Severe liver function damage, ALT or AST greater than or equal to 2 times the upper limit of normal
- Hypernatremia, serum sodium≥145mmol/L
- Diagnosis as severe pneumonia:
- Diagnostic criteria of severe pneumonia: patients who meet one major criteria or at least 3 of these minor criteria are classified as severe cases: Major criteria:①the need for invasive mechanical ventilation②sepsis shock after active fluid resuscitation still need vasoactive drugs; Minor criteria:①respiratory rate >30 breaths/min, ②PaO2/FiO2≤250mmHg（1mmHg=0.133kPa）, ③multilobar infiltrates, ④confusion or/andunorientation, ⑤bloodurea nitrogen level≥20mg/dl（7.14mmol/L）, ⑥systolic pressure <90mmHg need active fluid resuscitation
- Defervescence by using corticosteroid after symptom onset.
- Patients who participated another intervention study within a month
- Other conditions not suitable for inclusion according to the investigator' judgment.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites, 2 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Xiaojing Cui, MD, +86 10 84206269, cuixiaojing86@163.com
Bin Cao, MD, +86 13911318339, caobin_ben@163.com
- Active, not recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality
- Active, not recruiting
Beijing Hospital of TCM
Beijing, Beijing Municipality
- Active, not recruiting
Beijing LuHe Hospital, Capital Medical University
Beijing, Beijing Municipality
- Recruiting
Fu Xing Hospital, Capital Medical Unviersity
Beijing, Beijing Municipality
Jin Chen, MD
- Active, not recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
- Active, not recruiting
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi
- Active, not recruiting
Nanjing General Hospital
Nanjing, Jiangsu
- Active, not recruiting
Qingdao Municipal Hospital
Qingdao, Shandong
- Active, not recruiting
First Hospital of QinHuangDao
Qinhuangdao, Hebei
- Active, not recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
- Active, not recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
- Active, not recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi
- Active, not recruiting
The General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
- Active, not recruiting
The First Affiliated Hospital of Wenzhou University
Wenzhou, Fujian
- Active, not recruiting
The Central Hospital of ZiBo City
Zibo, Shandong
About this study
Official title: Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia: A Multicenter Randomized Controlled Clinical Trial
Adjunctive Therapy of AndrographolidSulfonate in Community Acquired Pneumonia: A Multicenter, Randomized,Double-blinded, Placebo Controlled Clinical Trial. The hypothesis is that combination therapy with Andrographolid Sulfonatein injection and antibacterial is significantly better than antibacterial alone in achieving clinical stability among hospitalized CAP patients.
- Conditions
- Community Acquired Pneumonia
- Being tested
- Andrographolid Sulfonate Injection (AS Injection), Cephalosporin, Azithromycin, Minocycline or Doxycycline, Amoxicillin-clavulantic acid, Fluoroquinolones
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andrographolid Sulfonate Injection (AS Injection)Drug
CephalosporinDrug
Azithromycin, Minocycline or DoxycyclineDrug
Amoxicillin-clavulantic acidDrug
FluoroquinolonesDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| standard antibiotic treatment +AS injection | Experimental | Andrographolid Sulfonate Injection (AS Injection) plus one of 3 antibiotics in China CAP Guideline Receives: Drug: Andrographolid Sulfonate Injection (AS Injection); Drug: Cephalosporin; Drug: Azithromycin, Minocycline or Doxycycline; Drug: Amoxicillin-clavulantic acid; Drug: Fluoroquinolones |
| standard antibiotic treatment + AS placebo | Placebo comparator | AS placebo (NS injection) plus one of 3 antibiotics in China CAP Guideline Receives: Drug: Cephalosporin; Drug: Azithromycin, Minocycline or Doxycycline; Drug: Amoxicillin-clavulantic acid; Drug: Fluoroquinolones; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to clinical stability
Measured: 14 days
number of study participants with treatment-related adverse events as assessed by CTCAE v4.0
symptoms and signs, blood and urine routine, liver and kidney function monitoring, ECG, side effects of long-time using of antibiotics
Measured: 14 days
Secondary outcomes (6)
the duration of fever
Measured: 14 days
the initial treatment failure rate
Measured: 14 days
length of stay in hospital
Measured: 14 days
questionnaire for hospitalization expenses
Measured: 14 days
the duration of intravenous antibiotic treatment
Measured: 14 days
the rate of diarrhea and intestinal dysbacteriosis
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 462 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingfeng Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen Wang, Professor, Principal investigator, China-Japan Friendship HospitalBin Cao, Professor, Principal investigator, China-Japan Friendship HospitalJin Chen, Professor, Principal investigator, Fu Xing Hospital, Capital Medical UniversityYuguang Wang, Professor, Principal investigator, Beijing Hospital of TCMLi Gu, Professor, Principal investigator, Beijing Chao Yang HospitalZhenyang Xu, Professor, Principal investigator, Capital Medical UniversityYan Yi, Professor, Principal investigator, First Hospital of China Medical UniversityWei Zhang, Professor, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913118
- Sponsor's protocol ID
- QF-CAP-20160402
- Status last verified
- Apr 2018
- First submitted
- 12 Sep 2016
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shang LH, Fan GH, Chen LP, Liu JH, Wang XG, Liu B, Tian GZ, Chen XS, Yu JX, Yang GR, Su X, Liu XD, Li YP, Xu SF, Lin YH, Cao J, Zhang W, Feng WS, Cai ZG, Wang QH, Wang JX, Wang YG, Chen J, Zhang YX, Cui XJ. Andrographolide Sulfonate Injection for Adjunctive Treatment of Non-severe Community-Acquired Pneumonia in Adults: A Multicenter, Double-Blind, Randomized Controlled Trial. Chin J Integr Med. 2026 Sep;32(9):771-779. doi: 10.1007/s11655-025-3932-8. Epub 2026 Jan 5.
PubMed 41489779
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia: A Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02913118
- Acronym / sponsor ID
- QF-CAP-20160402
- Conditions
- Community Acquired Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 462 participants (estimated)
- Lead sponsor
- Qingfeng Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 23 Sep 2016 (estimated)
- 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.
Adjunctive Therapy of AndrographolidSulfonate in Community Acquired Pneumonia: A Multicenter, Randomized,Double-blinded, Placebo Controlled Clinical Trial. The hypothesis is that combination therapy with Andrographolid Sulfonatein injection and antibacterial is significantly better than antibacterial alone in achieving clinical stability among hospitalized CAP patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard antibiotic treatment +AS injection | Experimental | Drug: Andrographolid Sulfonate Injection (AS Injection), Drug: Cephalosporin, Drug: Azithromycin, Minocycline or Doxycycline, Drug: Amoxicillin-clavulantic acid, Drug: FluoroquinolonesAndrographolid Sulfonate Injection (AS Injection) plus one of 3 antibiotics in China CAP Guideline |
| standard antibiotic treatment + AS placebo | Placebo comparator | Drug: Cephalosporin, Drug: Azithromycin, Minocycline or Doxycycline, Drug: Amoxicillin-clavulantic acid, Drug: Fluoroquinolones, Drug: PlaceboAS placebo (NS injection) plus one of 3 antibiotics in China CAP Guideline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age of 18-75 years, no gender restrictions.
- Voluntary participation, all participants provide written informed consent.
- Volunteers are hospitalized patients
- Patients are hospitalized for community acquired pneumonia with T≥38°C within 24 hours before being enrolled Diagnosis of CAP(Chinese Guideline for Diagnosis and Management of Community Acquired Pneumonia in Adults 2016)
- <!-- -->
Key exclusion criteria (16 listed)
- Known allergy to AS
- Pregnant or breast-feeding
- Heart dysfunction, NYHA III-IV class
- Hematological system diseases, such as lymphoma, leukemia, agranulocytosis (neutrophil count< 0.5×109/L).
- Autoimmune diseases and disease active
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 |
|---|---|---|
| Andrographolid Sulfonate Injection (AS Injection) | Drug | standard antibiotic treatment +AS injection |
| Cephalosporin | Drug | standard antibiotic treatment + AS placebo, standard antibiotic treatment +AS injection |
| Azithromycin, Minocycline or Doxycycline | Drug | standard antibiotic treatment + AS placebo, standard antibiotic treatment +AS injection |
| Amoxicillin-clavulantic acid | Drug | standard antibiotic treatment + AS placebo, standard antibiotic treatment +AS injection |
| Fluoroquinolones | Drug | standard antibiotic treatment + AS placebo, standard antibiotic treatment +AS injection |
| Placebo | Drug | standard antibiotic treatment + AS placebo |
Primary outcome
time to clinical stability
Time frame: 14 days
number of study participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 14 days
symptoms and signs, blood and urine routine, liver and kidney function monitoring, ECG, side effects of long-time using of antibiotics
6 secondary outcomes
the duration of fever
Time frame: 14 days
the initial treatment failure rate
Time frame: 14 days
length of stay in hospital
Time frame: 14 days
questionnaire for hospitalization expenses
Time frame: 14 days
the duration of intravenous antibiotic treatment
Time frame: 14 days
the rate of diarrhea and intestinal dysbacteriosis
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Derived from this study: PubMed 41489779Shang LH, Fan GH, Chen LP, Liu JH, Wang XG, Liu B, Tian GZ, Chen XS, Yu JX, Yang GR, Su X, Liu XD, Li YP, Xu SF, Lin YH, Cao J, Zhang W, Feng WS, Cai ZG, Wang QH, Wang JX, Wang YG, Chen J, Zhang YX, Cui XJ. Andrographolide Sulfonate Injection for Adjunctive Treatment of Non-severe Community-Acquired Pneumonia in Adults: A Multicenter, Double-Blind, Randomized Controlled Trial. Chin J Integr Med. 2026 Sep;32(9):771-779. doi: 10.1007/s11655-025-3932-8. Epub 2026 Jan 5.
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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.
Chen Wang, Professor principal investigator
China-Japan Friendship Hospital
Bin Cao, Professor principal investigator
China-Japan Friendship Hospital
Jin Chen, Professor principal investigator
Fu Xing Hospital, Capital Medical University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Andrographolid Sulfonate Injection (AS Injection), Cephalosporin and Azithromycin, Minocycline or Doxycycline in people with Community Acquired Pneumonia, run by Qingfeng Pharmaceutical Group at 16 sites in China.
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 19 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Wang, Professor (+86 13901122992, cyh-birm@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to clinical stability (time frame: 14 days). The study lists 2 primary outcomes in all. 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 NCT02913118, which also lists 1 linked publication.
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 10 Apr 2018.