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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER


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All Clinical Trials for Clindamycin Phosphate In Dextrose 5% In Plastic Container

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00160394 ↗ Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris Completed GlaxoSmithKline Phase 4 2004-12-01 Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
NCT00160394 ↗ Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris Completed Stiefel, a GSK Company Phase 4 2004-12-01 Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
NCT00219570 ↗ Dalacin-T Gel Post Approval Study Completed Acronet Phase 4 2005-01-01 To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify the clinical positioning of Dalacin T Gel.
NCT00219570 ↗ Dalacin-T Gel Post Approval Study Completed Bellsystem24 , Inc. Phase 4 2005-01-01 To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify the clinical positioning of Dalacin T Gel.
NCT00219570 ↗ Dalacin-T Gel Post Approval Study Completed Mitsubishi Kagaku Bio-Clinical Laboratories, inc Phase 4 2005-01-01 To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify the clinical positioning of Dalacin T Gel.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Clindamycin Phosphate In Dextrose 5% In Plastic Container

Condition Name

Condition Name for Clindamycin Phosphate In Dextrose 5% In Plastic Container
Intervention Trials
Acne Vulgaris 18
BACTERIAL VAGINOSIS 3
Acne 2
Skin Toxicity 1
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Condition MeSH

Condition MeSH for Clindamycin Phosphate In Dextrose 5% In Plastic Container
Intervention Trials
Acne Vulgaris 20
Vaginosis, Bacterial 3
Vaginal Diseases 2
Hyperpigmentation 1
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Clinical Trial Locations for Clindamycin Phosphate In Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Clindamycin Phosphate In Dextrose 5% In Plastic Container
Location Trials
United States 90
India 19
China 10
Russian Federation 4
Puerto Rico 2
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Trials by US State

Trials by US State for Clindamycin Phosphate In Dextrose 5% In Plastic Container
Location Trials
Pennsylvania 6
New York 6
Texas 5
Florida 5
California 5
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Clinical Trial Progress for Clindamycin Phosphate In Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Clindamycin Phosphate In Dextrose 5% In Plastic Container
Clinical Trial Phase Trials
Phase 4 10
Phase 3 9
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Clindamycin Phosphate In Dextrose 5% In Plastic Container
Clinical Trial Phase Trials
Completed 25
Unknown status 4
Recruiting 1
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Clinical Trial Sponsors for Clindamycin Phosphate In Dextrose 5% In Plastic Container

Sponsor Name

Sponsor Name for Clindamycin Phosphate In Dextrose 5% In Plastic Container
Sponsor Trials
GlaxoSmithKline 6
Stiefel, a GSK Company 4
Daré Bioscience, Inc. 2
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Sponsor Type

Sponsor Type for Clindamycin Phosphate In Dextrose 5% In Plastic Container
Sponsor Trials
Industry 35
Other 16
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Clindamycin Phosphate in Dextrose 5%: Clinical Trials, Market Analysis, and Projections

Introduction to Clindamycin Phosphate in Dextrose 5%

Clindamycin phosphate in 5% dextrose is a potent antibiotic used to treat a variety of serious bacterial infections. This formulation is particularly useful for intravenous administration, making it a critical component in the treatment of severe infections.

Clinical Pharmacology and Mechanism of Action

Clindamycin phosphate is a biologically inactive compound that is converted to active clindamycin in the body. It works by inhibiting bacterial protein synthesis, thereby preventing the growth and multiplication of bacteria. Peak serum concentrations of active clindamycin are reached by the end of a short-term intravenous infusion, and within 3 hours after intramuscular injection in adults[1][3][4].

Indications and Usage

Clindamycin in 5% dextrose injection is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria, streptococci, pneumococci, and staphylococci. These include lower respiratory tract infections, skin and skin structure infections, gynecological infections, intra-abdominal infections, and septicemia. It is particularly useful for patients allergic to penicillin or when penicillin is deemed inappropriate by the physician[1][3][4].

Clinical Trials and Efficacy

While specific recent clinical trial data may not be readily available, the efficacy of clindamycin phosphate in treating bacterial infections is well-established. Clinical trials have consistently shown that clindamycin is effective in maintaining serum concentrations above the minimum inhibitory concentrations for most indicated organisms, ensuring effective treatment of infections[1][3].

Safety and Side Effects

Clindamycin phosphate carries a risk of antibiotic-associated pseudomembranous colitis, a condition highlighted in the BOXED WARNING. Physicians must consider the nature of the infection and the suitability of less toxic alternatives before prescribing clindamycin. Bacteriologic studies are essential to determine the causative organisms and their susceptibility to clindamycin[1][3][4].

Market Analysis

Current Market Size

The global market for clindamycin phosphate injection is substantial and growing. As of 2024, the market size is estimated to be around $486.4 million[5].

Growth Projections

The market is expected to grow at a compound annual growth rate (CAGR) of 7.7% from 2024 to 2030, reaching $759.1 million by the end of the forecast period. This growth is driven by the rising prevalence of bacterial infections, the increasing incidence of antibiotic-resistant bacterial infections, and the expanding healthcare infrastructure in emerging economies[5].

Trends and Drivers

Several trends are driving the growth of the clindamycin phosphate market:

  • Rising Cases of Bacterial Infections: The increase in bacterial skin infections such as acne and cellulitis, as well as other severe infections, is a significant driver[2].
  • Antibiotic Resistance: The growing problem of antibiotic resistance among bacterial strains like Staphylococcus aureus necessitates the use of effective antibiotics like clindamycin[2].
  • Advancements in Formulations: The development of more efficient topical and injectable formulations of clindamycin is enhancing its market appeal[2].
  • Healthcare Infrastructure Expansion: The growth in healthcare infrastructure in developing regions is increasing the demand for effective antibiotic treatments[2].

Market Players and Recent Developments

Hikma Pharmaceuticals

Hikma Pharmaceuticals recently launched Clindamycin in 5% Dextrose Injection in the US, available in 300mg/50mL, 600mg/50mL, and 900mg/50mL doses. This launch expands the availability of this critical antibiotic in the market[4].

Global Market Outlook

The global clindamycin phosphate market is expected to see significant growth, driven by the increasing demand for effective treatments for bacterial infections. The topical clindamycin phosphate market, for instance, is projected to grow from $0.94 billion in 2023 to $1.07 billion in 2024 and further to $1.86 billion by 2028, at a CAGR of 14.8%[2].

Compatibility and Administration

Clindamycin in 5% dextrose injection is compatible with various IV solutions, including those containing sodium chloride, glucose, calcium, potassium, and vitamin B complex. It has also been shown to be compatible with other antibiotics such as cephalothin, kanamycin, gentamicin, penicillin, and carbenicillin[4].

Preparation and Administration

The solution should be inspected visually for particulate matter and discoloration before administration. It is crucial to check for minute leaks in the container and ensure the solution is clear and the seal is intact. The administration set should be attached according to the complete directions accompanying the set[3].

Key Takeaways

  • Efficacy: Clindamycin phosphate in 5% dextrose is effective in treating serious bacterial infections, including those caused by anaerobic bacteria, streptococci, pneumococci, and staphylococci.
  • Market Growth: The global market for clindamycin phosphate injection is expected to grow significantly, driven by rising bacterial infections and antibiotic resistance.
  • Trends: Advancements in formulations, expanding healthcare infrastructure, and the adoption of clindamycin-based combination therapies are key trends.
  • Safety: The risk of antibiotic-associated pseudomembranous colitis must be considered, and bacteriologic studies are essential to determine susceptibility.

FAQs

What is Clindamycin Phosphate in 5% Dextrose used for?

Clindamycin Phosphate in 5% Dextrose is used to treat serious infections caused by susceptible anaerobic bacteria, streptococci, pneumococci, and staphylococci, including lower respiratory tract infections, skin and skin structure infections, gynecological infections, intra-abdominal infections, and septicemia[1][3][4].

How is Clindamycin Phosphate administered?

Clindamycin Phosphate in 5% Dextrose is administered intravenously using sterile equipment. It is available in vials and plastic containers, and the solution should be inspected for particulate matter and discoloration before use[1][3][4].

What are the potential side effects of Clindamycin Phosphate?

Clindamycin Phosphate carries a risk of antibiotic-associated pseudomembranous colitis, a condition highlighted in the BOXED WARNING. Other potential side effects include gastrointestinal disturbances and allergic reactions[1][3][4].

Is Clindamycin Phosphate compatible with other antibiotics?

Yes, Clindamycin Phosphate in 5% Dextrose is compatible with various IV solutions and other antibiotics such as cephalothin, kanamycin, gentamicin, penicillin, and carbenicillin[4].

What is the market outlook for Clindamycin Phosphate?

The global market for Clindamycin Phosphate injection is expected to grow at a CAGR of 7.7% from 2024 to 2030, driven by the rising prevalence of bacterial infections and the increasing incidence of antibiotic-resistant bacterial infections[5].

Sources

  1. Drugs.com: Clindamycin in Dextrose Injection: Package Insert / Prescribing Info.
  2. The Business Research Company: Global Clindamycin Phosphate Topical Market Report 2024.
  3. Baxter PI: Clindamycin Injection USP in 5% Dextrose.
  4. Hikma: Hikma launches Clindamycin in 5% Dextrose Injection in the US.
  5. GII Research: Clindamycin Phosphate Injection Market Forecasts to 2030.

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