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Last Updated: March 18, 2025

CLINICAL TRIALS PROFILE FOR COLISTIN SULFATE


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All Clinical Trials for COLISTIN SULFATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT02472600 ↗ Eradication of Antibiotic-resistant Bacteria Through Antibiotics and Fecal Bacteriotherapy Unknown status European Commission Phase 2 2016-02-01 This investigator initiated,international, multicenter open-label, randomized controlled trial aims to assess whether a 5 day course of oral nonabsorbable antibiotics (colistin sulfate 2 million IU per os 4x/day and neomycin sulfate 500 mg (salt) per os 4x/day ) followed by fecal microbiota transplantation (administered either via nasogastric administration or via capsules) is effective at eradicating intestinal carriage of beta-lactamase producing Enterobacteriaceae (ESBL-E) and carbapenemase producing Enterobacteriaceae (CPE). compared to no intervention (current standard of care) in adult non-immunosuppressed patients .
NCT02472600 ↗ Eradication of Antibiotic-resistant Bacteria Through Antibiotics and Fecal Bacteriotherapy Unknown status Stephen Harbarth Phase 2 2016-02-01 This investigator initiated,international, multicenter open-label, randomized controlled trial aims to assess whether a 5 day course of oral nonabsorbable antibiotics (colistin sulfate 2 million IU per os 4x/day and neomycin sulfate 500 mg (salt) per os 4x/day ) followed by fecal microbiota transplantation (administered either via nasogastric administration or via capsules) is effective at eradicating intestinal carriage of beta-lactamase producing Enterobacteriaceae (ESBL-E) and carbapenemase producing Enterobacteriaceae (CPE). compared to no intervention (current standard of care) in adult non-immunosuppressed patients .
NCT02482961 ↗ Impact of Plasma Levels of Colistin in Patients With Carbapenem Resistant Acinetobacter Baumannii Infection Completed DongGuk University 2015-05-01 This study purposed to examine the adequate range of therapeutic concentration for Korean people by observing curative effects, side effects, blood concentration, etc. in treating CRAB-infected patients with colistin.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for COLISTIN SULFATE

Condition Name

1110-0.100.10.20.30.40.50.60.70.80.911.1Hepatic EncephalopathyIntestinal Colonization With Multidrug-resistant BacteriaMIC[disabled in preview]
Condition Name for COLISTIN SULFATE
Intervention Trials
Hepatic Encephalopathy 1
Intestinal Colonization With Multidrug-resistant Bacteria 1
MIC 1
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Condition MeSH

2220-0.200.20.40.60.811.21.41.61.822.2Communicable DiseasesInfectionsInfection[disabled in preview]
Condition MeSH for COLISTIN SULFATE
Intervention Trials
Communicable Diseases 2
Infections 2
Infection 2
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Clinical Trial Locations for COLISTIN SULFATE

Trials by Country

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Trials by Country for COLISTIN SULFATE
Location Trials
France 1
Switzerland 1
Egypt 1
Netherlands 1
United States 1
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Trials by US State

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Trials by US State for COLISTIN SULFATE
Location Trials
Pennsylvania 1
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Clinical Trial Progress for COLISTIN SULFATE

Clinical Trial Phase

33.3%33.3%33.3%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 4Phase 2Phase 1/Phase 2[disabled in preview]
Clinical Trial Phase for COLISTIN SULFATE
Clinical Trial Phase Trials
Phase 4 1
Phase 2 1
Phase 1/Phase 2 1
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Clinical Trial Status

50.0%25.0%25.0%0-0.200.20.40.60.811.21.41.61.822.2CompletedNot yet recruitingUnknown status[disabled in preview]
Clinical Trial Status for COLISTIN SULFATE
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 1
Unknown status 1
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Clinical Trial Sponsors for COLISTIN SULFATE

Sponsor Name

trials000001111111Madonna Magdy FahmyEuropean CommissionStephen Harbarth[disabled in preview]
Sponsor Name for COLISTIN SULFATE
Sponsor Trials
Madonna Magdy Fahmy 1
European Commission 1
Stephen Harbarth 1
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Sponsor Type

90.0%10.0%00123456789OtherIndustry[disabled in preview]
Sponsor Type for COLISTIN SULFATE
Sponsor Trials
Other 9
Industry 1
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Clinical Trials Update, Market Analysis, and Projections for Colistin Sulfate

Introduction to Colistin Sulfate

Colistin sulfate is a polymyxin antibiotic that has gained significant attention in recent years due to its effectiveness against multidrug-resistant Gram-negative bacteria, particularly carbapenem-resistant organisms (CROs). Here, we will delve into the latest clinical trials, market analysis, and future projections for this critical antibiotic.

Clinical Efficacy and Safety of Colistin Sulfate

Clinical Trials Overview

Recent clinical trials have provided valuable insights into the efficacy and safety of colistin sulfate. A retrospective study involving 226 patients infected with CROs from June 2020 to June 2023 showed promising results. The clinical efficacy rate of colistin sulfate was 54.87%, while the microbiological efficacy rate was 46.46%[1].

Key Outcomes

  • Clinical Efficacy: Significant reductions in body temperature, white blood cell count, C-reactive protein, and procalcitonin levels were observed, indicating effective treatment in 124 patients out of 226[1].
  • Microbiological Efficacy: Bacterial clearance or reduced bacterial load was achieved in 105 patients by the end of the treatment[1].
  • Mortality Rate: The in-hospital mortality rate was 20.80%, highlighting the severity of the infections being treated[1].
  • Adverse Reactions: Nephrotoxicity was observed in 11.50% of patients, although multifactorial analysis identified that this was often influenced by other factors such as APACHE II scores and vasoactive drug use[1].

Influencing Factors

The study identified several factors that impact the clinical efficacy of colistin sulfate:

  • Treatment Duration: Longer treatment durations (>10 days) were associated with better clinical outcomes[1].
  • Albumin Levels: Higher albumin levels (>34 g/L) correlated with effective treatment[1].
  • APACHE II Scores: Lower APACHE II scores (<13) were predictive of better clinical efficacy[1].
  • Vasoactive Drug Use: The use of vasoactive drugs was an independent predictor of ineffective treatment[1].

Population Pharmacokinetics and PK/PD Analysis

A study focusing on the population pharmacokinetics of colistin sulfate in critically ill patients provided additional insights:

  • Clinical Success: 59.52% of patients achieved clinical anti-infective success, defined by improvements in clinical symptoms and biochemical indicators[4].
  • Mortality Rates: The 30-day mortality rate was 23.81%, and the 14-day mortality rate was 16.67%[4].
  • Bacterial Elimination: 69.05% of patients had successful bacteria elimination by the end of treatment[4].
  • PK/PD Analysis: Monte Carlo simulations indicated that certain dose regimens could achieve high pharmacokinetic/pharmacodynamic (PK/PD) target attainment, especially for pathogens with MICs ≤0.5 μg/ml[4].

Market Analysis and Projections

Current Market Size

As of 2023, the global colistin sulfate market was valued at approximately USD 58 million[2][5].

Growth Projections

The market is expected to grow at a compound annual growth rate (CAGR) of 3.1% from 2024 to 2030, reaching USD 72 million by 2030[2][5].

Key Drivers

The growth of the colistin sulfate market is driven by several factors:

  • Increasing Prevalence of Multidrug-Resistant Infections: The rising incidence of infections resistant to multiple antibiotics has increased the demand for effective alternatives like colistin sulfate[5].
  • Cost-Effectiveness: Colistin sulfate is often more cost-effective compared to other last-resort antibiotics, making it an attractive option for healthcare providers[5].

Key Players

The market is dominated by several key players:

  • Xellia Pharmaceuticals
  • Tecoland
  • Clearsynth
  • JSN Chemicals
  • SNA Health Care
  • HBCChem
  • U.K. Vet Chem
  • Meiji
  • Fengchen Group
  • Fujian Lifecome Biochemistry
  • Sinopharm[2][5].

Market Segmentation

The colistin sulfate market is segmented based on type (minimum purity less than 95% and more than 95%) and application (research, medical, and veterinary)[2][3].

Future Market Opportunities and Challenges

Opportunities

  • Growing Demand: The increasing prevalence of multidrug-resistant infections will continue to drive the demand for colistin sulfate[5].
  • Expanding Applications: Potential expansion into veterinary and research applications could further boost market growth[2].

Challenges

  • Nephrotoxicity: The risk of nephrotoxicity remains a significant concern, necessitating careful patient monitoring and dose adjustment[1][4].
  • Resistance Development: The potential for bacterial resistance to colistin sulfate is a long-term challenge that requires continuous monitoring and research[1].

Key Takeaways

  • Clinical Efficacy: Colistin sulfate has shown significant clinical and microbiological efficacy in treating CRO infections.
  • Safety Profile: While generally safe, colistin sulfate can cause nephrotoxicity, which is influenced by several factors.
  • Market Growth: The global colistin sulfate market is expected to grow at a CAGR of 3.1% from 2024 to 2030.
  • Key Drivers: Increasing prevalence of multidrug-resistant infections and cost-effectiveness are driving market growth.
  • Key Players: Several pharmaceutical companies dominate the market, including Xellia Pharmaceuticals and Sinopharm.

FAQs

What is the current market size of the global colistin sulfate market?

The global colistin sulfate market was valued at approximately USD 58 million in 2023[2][5].

What is the projected growth rate of the colistin sulfate market from 2024 to 2030?

The market is expected to grow at a CAGR of 3.1% from 2024 to 2030[2][5].

What are the main applications of colistin sulfate?

The main applications include research, medical, and veterinary uses[2][3].

Which companies are the key players in the colistin sulfate market?

Key players include Xellia Pharmaceuticals, Tecoland, Clearsynth, JSN Chemicals, SNA Health Care, HBCChem, U.K. Vet Chem, Meiji, Fengchen Group, Fujian Lifecome Biochemistry, and Sinopharm[2][5].

What are the primary factors influencing the clinical efficacy of colistin sulfate?

Factors include treatment duration, albumin levels, APACHE II scores, and vasoactive drug use[1].

Sources

  1. Clinical Effectiveness and Safety of Colistin Sulphate in Treating Infections Caused by Carbapenem-Resistant Organisms - PMC, September 2024.
  2. Global Colistin Sulfate Market Research Report 2024 - Valuates Reports.
  3. Colistin Sulphate Market Report 2024 (Global Edition) - Cognitive Market Research.
  4. Population Pharmacokinetics of Colistin Sulfate in Critically Ill Patients - Frontiers in Pharmacology, June 2022.
  5. Colistin Sulfate Market Size, Share, Growth Research Report, 2032 - Business Research Insights.

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