Clinical Trials

Colistin is currently evaluated in numerous clinical trials investigating its safety and efficacy against severe Gram-negative pathogens, including pneumonia, peritonitis, and bloodstream infections caused by multidrug-resistant Klebsiella pneumoniae or Acinetobacter species. Spanning Early Phase 1 through Phase 4, these studies display varied recruitment statuses—ranging from not yet recruiting and active to completed or terminated—and are supported by diverse academic medical institutions and industry sponsors.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07004049 RECRUITING
Bloodstream Infection; Ventilator Associated Bacterial Pneumonia; Hospital Acquired Bacterial Pneumonia; Carbapenem Resistant Bacterial Infection; Multidrug Resistance
National University of Singapore
 2025-04-21 PHASE4
NCT07326540 RECRUITING
Hospital Acquired Bacterial Pneumonia (HABP); Ventilator Associated Bacterial Pneumonia (VABP); Colistin Resistanrt ABC; Acinetobacter Baumannii-calcoaceticus Complex
BioVersys SAS
 2026-03-27 PHASE3
NCT07668141 NOT_YET_RECRUITING
Nephrotoxicity
Helwan University
 2026-06-30 PHASE3
NCT06819462 RECRUITING
Ventilator-Associated Pneumonia (VAP); Inha'le'd
Southeast University, China
 2025-04-01
NCT07089186 RECRUITING
Hospital-acquired Bacterial Pneumonia (HABP); Ventilator-associated Bacterial Pneumonia (VABP); Complicated Intra-abdominal Infection (cIAI); Complicated Urinary Tract Infection (cUTI); Bloodstream Infection (BSI)
Qilu Pharmaceutical Co., Ltd.
 2025-04-12 PHASE3
NCT06834971 RECRUITING
Ventilator-Associated Pneumonia (VAP)
Qilu Hospital of Shandong University
 2025-07-15
NCT07694700 ACTIVE_NOT_RECRUITING
MDR Bacteria
Beni-Suef University
 2025-12-30 PHASE4
NCT07503600 NOT_YET_RECRUITING
Multidrug-Resistant Gram-Negative Bacterial Infections; Antimicrobial Resistance
Ain Shams University
 2026-03-26 PHASE3
NCT07524920 NOT_YET_RECRUITING
MDR Bacteria
Ain Shams University
 2026-04-01 PHASE2
NCT06230614 RECRUITING
Inhalation Pneumonia
Fu Jen Catholic University
 2024-03-10
NCT05922124 RECRUITING
Carbapenem Resistant Bacterial Infection; Acinetobacter Bacteremia; Acinetobacter Pneumonia
Rambam Health Care Campus
 2024-09-01 PHASE4
NCT06650384 COMPLETED
Nephrotoxicity
Ain Shams University
 2024-11-01 PHASE2; PHASE3
NCT06051513 RECRUITING
Carbapenem-Resistant Enterobacteriaceae Infection
Southeast University, China
 2023-11-27
NCT07671755 COMPLETED
Clinical Response; Radiological Response
Shaheed Mohtarma Benazir Bhutto Institue of Trauma
 2025-02-01
NCT06843668 RECRUITING
Critical Ill Patients; Multi Drug Resistant
Mansoura University
 2023-12-25 PHASE2; PHASE3
NCT06893835 ACTIVE_NOT_RECRUITING
Infection in ICU
Beni-Suef University
 2024-12-01 PHASE4
NCT06570850 UNKNOWN
Infection Due to Carbapenem Resistant Acinetobacter
Chiang Mai University
 2023-04-01 PHASE4
NCT05613361 UNKNOWN
Acute Kidney Injury; Drug-Induced Nephropathy
October 6 University
 2023-01-01 PHASE3
NCT05586815 UNKNOWN
Acinetobacter Infections
Mahidol University
 2023-01-10 PHASE4
NCT05542446 TERMINATED
Colistin
St. Anne's University Hospital Brno, Czech Republic
 2022-09-01 PHASE4
NCT06087536 Not yet recruiting
Hospital-acquired Bacterial Pneumonia|Ventilator-associated Bacterial Pneumonia
Omnix Medical Ltd
 2024-01 Phase 2
NCT05258851 TERMINATED
Carbapenem-Resistant Enterobacteriaceae Infection
King Faisal Specialist Hospital & Research Center
 2022-06-01 PHASE3
NCT03329092 COMPLETED
Complicated Intra-abdominal Infection; Hosptial Acquired Pneumonia; Ventilator Associated Pneumonia
Pfizer
 2018-04-05 PHASE3
NCT05279586 UNKNOWN
Hepatic Encephalopathy
Madonna Magdy Fahmy
 2022-03 EARLY_PHASE1
NCT05586438 COMPLETED
Bacterial Infections
Mahidol University
 2021-10-18 PHASE4
NCT05542446 Terminated
Colistin
St. Anne''s University Hospital Brno Czech Republic|Palacky University
 2022-09-01 Phase 4
NCT04633317 COMPLETED
Pneumonia, Bacterial
Chang Gung University
 2020-12-15
NCT04995133 UNKNOWN
Hospital Infection; Multi-antibiotic Resistance; Critically Ill
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2021-07-14 PHASE4
NCT04208763 UNKNOWN
Spontaneous Bacterial Peritonitis
Institute of Liver and Biliary Sciences, India
 2019-12-20
NCT06827756 COMPLETED
Spontaneous Bacterial Peritonitis; Cirrhoses, Liver; Ascites
Tanta University
 2021-03-01 PHASE4
NCT05689229 COMPLETED
Secondary Bacterial Infection in COVID-19 Patients
Beni-Suef University
 2021-08-03 PHASE3
NCT03894046 COMPLETED
Acinetobacter Baumannii-calcoaceticus Complex; Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia; Bacteremia; Colistin Resistant ABC
Entasis Therapeutics
 2019-09-05 PHASE3
NCT04208945 UNKNOWN
Pneumonia, Ventilator-associated; Gram-Negative Pneumonia
University of Thessaly
 2019-12
NCT04775238 Unknown status
Nosocomial Infections
Sohag University
 2021-02-27 Not Applicable
NCT02918409 COMPLETED
Cystic Fibrosis
National Jewish Health
 2016-08-26 PHASE4
NCT01597973 COMPLETED
Pneumonia; Blood Stream Infection
University of Michigan
 2012-10-06 PHASE3
NCT04489459 UNKNOWN
Treatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella Pneumoniae
Al-Azhar University
 2019-09-21 PHASE4
NCT04208945 Unknown status
Pneumonia Ventilator-associated|Gram-Negative Pneumonia
University of Thessaly
 2019-12 Not Applicable
NCT04764058 UNKNOWN
Septicemia; Bacterial Infections
Ain Shams University
 2017-09-01 PHASE1; PHASE2
NCT02894684 COMPLETED
Cystic Fibrosis; Infection; Pseudomonas
Liverpool Heart and Chest Hospital NHS Foundation Trust
 2017-01 PHASE4
NCT03397914 COMPLETED
Gram-Negative Bacterial Infections; Pediatric Cancer; Colistin; Colistin Adverse Reaction; MIC
National Cancer Institute, Egypt
 2017-01 PHASE4
NCT02117986 UNKNOWN
Gram Negative Bacterial Infections
Hospital Barros Luco Trudeau
 2014-04 PHASE4
NCT03622450 COMPLETED
Ventilator Associated Pneumonia
Nourhan Hassan Osama Thuraya Mohamed
 2016-01-02 PHASE2; PHASE3
NCT03007290 COMPLETED
Multidrug-resistant Gram-negative Bacteria Infection
Seoul National University Hospital
 2016-01
NCT02472600 UNKNOWN
Intestinal Colonization With Multidrug-resistant Bacteria
Stephen Harbarth
 2016-02 PHASE2
NCT02806141 TERMINATED
Pneumonia, Ventilator-Associated; Colistin Adverse Reaction; Infection Due to Multidrug Resistant Acinetobacter; Infection Resistant to Multiple Drugs
Hat Yai Medical Education Center
 2016-09 PHASE3
NCT03622918 COMPLETED
Colistin; Rifampin; Acinetobacter Infections
Gangnam Severance Hospital
 2016-10-27
NCT02619786 UNKNOWN
Bronchitis
Mahidol University
 2015-12 PHASE3
NCT01740947 TERMINATED
Colorectal Cancer
H. Jaap Bonjer, PhD
 2013-01 PHASE4
NCT01732250 COMPLETED
Gram-Negative Bacterial Infections
Mical Paul
 2013-03 PHASE4
NCT02162966 UNKNOWN
Infectious Diseases
King Saud Medical City
 2014-05 PHASE4
NCT01970371 COMPLETED
Bloodstream Infections (BSI) Due to CRE; Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE; Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE; Complicated Urinary Tract Infection (cUTI) Due to CRE; Acute Pyelonephritis (AP) Due to CRE
Achaogen, Inc.
 2014-09-16 PHASE3
NCT03341741 COMPLETED
Cystic Fibrosis With Pulmonary Manifestations
University Hospital Tuebingen
 2014-03-11 PHASE3
NCT01292031 COMPLETED
Ventilator-associated Bacterial Pneumonia
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2012-05 PHASE3
NCT00235690 COMPLETED
Bacteremia; Pseudomonas Infections
University of Pittsburgh
 2008-06
NCT02081560 UNKNOWN
Infection
University of Zurich
 2013-11 PHASE4
NCT01798537 UNKNOWN
Bacteremia Associated With Intravascular Line; Ventilator Associated Pneumonia; Bacteremia
Rambam Health Care Campus
 2013-06 PHASE2; PHASE3
NCT02683603 COMPLETED
Pneumonia, Ventilator-Associated
Tunis University
 2013-04 PHASE4
NCT01060891 COMPLETED
Gram-negative Bacteria
Poitiers University Hospital
 2009-05 PHASE1
NCT02156323 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2014-07 PHASE1
NCT01845246 COMPLETED
Multidrug Resistant Gram Negative Bacterial Infections
Parc de Salut Mar
 2012-01
NCT00411736 COMPLETED
Cystic Fibrosis
Rigshospitalet, Denmark
 2008-05 PHASE4
NCT01501968 UNKNOWN
Drug Safety
Mahidol University
 2012-01 PHASE3
NCT02408185 COMPLETED
Critical Illness
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2011-10 PHASE1
NCT01025921 COMPLETED
Tracheobronchitis; Pneumonia
University of Thessaly
 2009-11
NCT01297855 UNKNOWN
Drug Safety
Mahidol University
 2010-06 PHASE3
NCT01297894 UNKNOWN
Drug Safety
Mahidol University
 2010-06 PHASE3
NCT01035853 COMPLETED
Cystic Fibrosis; Pseudomonas Aeruginosa
University of Jena
 2009-12 PHASE2
NCT01577862 COMPLETED
Infection Due to Resistant Bacteria; Pneumonia, Ventilator-Associated; Hospital Acquired Pneumonia; Infection of Bloodstream; Infectious Disease of Abdomen
University of Campania Luigi Vanvitelli
 2008-11 PHASE3
NCT00645723 UNKNOWN
Cross Infection; Pneumonia, Bacterial
Hospitales Universitarios Virgen del Rocío
 2008-04 PHASE3
NCT01631968 COMPLETED
Infection After Primary Total Knee Arthroplasty
Parc de Salut Mar
 2007-09
NCT01266499 COMPLETED
Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia
Rambam Health Care Campus
 2009-07
NCT01449838 COMPLETED
Infections, Pseudomonas
GlaxoSmithKline
 2010-10-23 PHASE1
NCT01400750 COMPLETED
Cystic Fibrosis
Universitaire Ziekenhuizen KU Leuven
 2001-08 PHASE4
NCT00920270 UNKNOWN
Pneumonia
Mahidol University
 2006-06 PHASE3
NCT00300560 UNKNOWN
Infections
Mahidol University
 2006-02 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-06-04)

Check the Colistin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Colistin acts as a polycationic peptide that selectively binds to lipopolysaccharides and phospholipids in the outer membrane of Gram-negative bacteria, displacing divalent cations and destabilizing membrane integrity. This loss of membrane stability leads to intracellular leakage and bacterial cell death, providing essential bactericidal activity against multidrug-resistant pathogens evaluated in trials for ventilator-associated pneumonia and spontaneous bacterial peritonitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.