5 completed, 5 recruiting, 5 unknown, 2 not yet recruiting. 5 Phase 2, 5 Phase 3, 4 Phase 1, 3 Not applicable, 2 Early Phase 1.
Follow Polymyxin B: new trials by email Literature Review of Polymyxin B trials Research Report on Polymyxin B
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex BV100 with 50 mg polymyxin B plus ceftazidime/avibactam, BV100 with 50 mg polymyxin B plus cefiderocol, Best Available Therapy (BAT) - Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP) | Phase 2 | Not yet recruiting | BioVersys AG | 120 | 2026-07-01 | 2026-02-24 |
| A Phase I Study Comparing the Safety, Pharmacokinetics and Renal Effects of VRP-034 and Marketed Polymyxin B in Healthy Volunteers VRP-034 (Polymyxin B 500,000 IU), Commercially available Polymyxin B 500,000 IU (Poly-MxB) - Healthy Volunteers | Phase 1 | Not yet recruiting | Venus Remedies Limited | 48 | 2026-04-01 | 2026-03-30 |
| Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex BV100 (300 mg), Polymyxin B, Colistin - Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP) | Phase 3 | Recruiting | BioVersys SAS | 248 | 2026-03-27 | 2026-05-04 |
| ASK0912 Versus Polymyxin B for Injection in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia ASK0912 for Injection, Polymyxin B Sulfate for Injection - Ventilator-associated Bacterial Pneumonia (VABP), Hospital-acquired Bacterial Pneumonia (HABP) | Phase 2 | Recruiting | Jiangsu Aosaikang Pharmaceutical Co., Ltd. | 60 | 2026-03-25 | 2026-08-12 |
| A Single Centre, Open-label, 2-period Fixed-sequence, Phase I Clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Polymyxin B in Healthy Volunteers BV100 (300 mg), Polymyxin B (50 mg) - Healthy Adult Participants | Phase 1 | Recruiting | BioVersys SAS | 16 | 2026-03-22 | 2026-05-12 |
| Optimising TREATment for Severe Gram-Negative Bacterial Infections Colistin/Polymyxin B + Sulbactam, Colistin/Polymyxin B + Tigecycline/Eravacycline, Colistin/Polymyxin B + Meropenem - Bloodstream Infection, Ventilator Associated Bacterial Pneumonia | Phase 4 | Recruiting | National University of Singapore | 600 | 2025-04-21 | 2025-06-04 |
| Intraventricular Administration of Intracranial Infections Caused by （Carbapenem-resistant Gram-negative Bacilli）CRGNB Polymyxin B - Intracranial Infections | Recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 222 | 2024-06-25 | 2024-09-19 | |
| PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB BV100 plus Polymyxin B, BAT - Ventilator Associated Pneumonia | Phase 2 | Completed | BioVersys AG | 39 | 2023-04-20 | 2025-01-14 |
| A Pharmacokinetic Study of Polymyxin B in Healthy Subjects and Subjects With Renal Insufficiency Polymyxin B - Antibiotic Toxicity | Phase 1 | Completed | TTY Biopharm | 22 | 2022-07-26 | 2023-04-27 |
| Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6h, Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6h, Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qd - Pneumonia, Ventilator-Associated, Pneumonia | Not applicable | Unknown | MEDSI Clinical Hospital 1, ICU | 60 | 2021-05-01 | 2021-06-08 |
| Study of Subretinally Injected ATSN-101 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D ATSN-101, ATSN-101 Diluent Solution, Prednisone - Leber Congenital Amaurosis, LCA | Phase 1 / Phase 2 | Active not recruiting | Atsena Therapeutics Inc. | 15 | 2019-10-22 | 2026-08-03 |
| The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae Fosfomycin, Tigecycline, Polymyxin B - Antibiotic Resistant Infection | Early Phase 1 | Unknown | Shanghai 10th People's Hospital | 80 | 2019-01-01 | 2019-05-15 |
| Polymyxin B Monotherapy vs Combination Therapy in Critically Ill Patients With Multi-drug Resistant Pathogens Polymyxin B - Trauma, Resistant Infection | Phase 3 | Unknown | University of Puerto Rico | 40 | 2017-05-25 | 2019-02-08 |
| Randomized-controlled Trial (RCT) on Combination Antibiotic for Infections Caused by Gram-negative Bacteria Polymyxin B, Polymyxin B + Doripenem - Bacteremia, Healthcare-associated Pneumonia | Phase 2 / Phase 3 | Withdrawn | Tan Tock Seng Hospital | 2015-01-01 | 2019-10-09 | |
| Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria Polymyxin B - Hospital Infection | Phase 4 | Unknown | Mahidol University | 100 | 2014-12-01 | 2015-09-01 |
| Antibiotic Irrigation for Pancreatoduodenectomy Polymyxin B in Normal Saline, Placebo: Normal Saline - Surgery, Infection | Not applicable | Completed | Indiana University | 190 | 2014-11-01 | 2022-02-23 |
| Patients Response to Early Switch To Oral:Osteomyelitis Study oral antibiotics, intravenous antibiotics - Osteomyelitis | Early Phase 1 | Terminated | Julio Ramirez | 11 | 2014-03-06 | 2021-04-06 |
| Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous polymyxin B sulphate + prednisolone + benzocaine + clioquinol, betamethasone + gentamicin + tolnaftato + cleoquinol - Eczema | Phase 3 | Completed | EMS | 76 | 2012-05-01 | 2021-02-24 |
| The Effect of Glaucoma Drops on of the Duration of a Pure Intraocular Gas Bubble Timolol-dorzolamide (Glaucoma drops), standard post-operative topical drops - Scleral Buckling | Not applicable | Completed | Jason Hsu, MD | 21 | 2011-06-01 | 2018-05-30 |
| Comparison of Combination Antibiotics Eyedrop to Artificial Tear in Hordeolum After Incision and Curettage neomycin sulfate, polymyxin B sulfate and gramicidin, Artificial tear - Hordeolum | Phase 3 | Unknown | Chulalongkorn University | 120 | 2007-09-01 | 2010-11-23 |
Pneumonia, Ventilator-Associated (3) · Critical Illness (2) · Sepsis (2) · Acute Kidney Injury (1) · Bacteremia (1) · Central Nervous System Infections (1) · Cerebral Ventriculitis (1) · Coinfection (1) · Cross Infection (1) · Dermatitis (1) · Dermatitis, Atopic (1) · Eczema (1) · Healthcare-Associated Pneumonia (1) · Hordeolum (1) · Infections (1)
BioVersys AG (2) · BioVersys SAS (2) · Atsena Therapeutics Inc. (1) · Chulalongkorn University (1) · EMS (1) · Indiana University (1) · Jason Hsu, MD (1) · Jiangsu Aosaikang Pharmaceutical Co., Ltd. (1) · Julio Ramirez (1) · MEDSI Clinical Hospital 1, ICU (1) · Mahidol University (1) · National University of Singapore (1) · Second Affiliated Hospital, Zhejiang University, School of Medicine (1) · Shanghai 10th People's Hospital (1) · TTY Biopharm (1)
China (4) · United States (4) · Thailand (3) · Georgia (2) · Singapore (2) · Australia (1) · Austria (1) · Greece (1) · Hungary (1) · India (1) · Lebanon (1) · Malaysia (1) · Puerto Rico (1) · Qatar (1) · Russia (1)
David Lye, MBBS, FRACP (1) · David Seligson, MD (1) · Dmitry Azovskiy, MD, phD (1) · Hiren Prajapati, MD Pharmacology (1) · Jason Hsu, MD (1) · Juan M Maldonado Lozada, PharmD (1) · Julio Ramirez, MD (1) · Li Hua, master (1) · Lisa Husband, MD (1) · Michael House, MD (1) · Parima Hirunwiwatkul, MD (1) · Visanu Thamlikitkul, MD (1)
PMID 15269195, PMID 15276398, PMID 15840453, PMID 17121631, PMID 17291803, PMID 18199038, PMID 18444865, PMID 18625681, PMID 19374579, PMID 19588358, PMID 20175247, PMID 21793988, PMID 22252816, PMID 22530208, PMID 22752516, PMID 23394211, PMID 23616495, PMID 23697744, PMID 24191943, PMID 24514083, PMID 24700659, PMID 25430979, PMID 25461655, PMID 26259799, PMID 27418577, PMID 35046672, PMID 3752106, PMID 39673151, PMID 4902833, PMID 8948280, PMID 9727997