#1 Clinical Trials Search in Europe

POTASSIUM CLAVULANATE

Potassium clavulanate is an important component in many antibiotic treatments, most commonly combined with amoxicillin. This combination creates a powerful antibiotic that treats various infections by overcoming bacterial resistance. In clinical trials, potassium clavulanate has been studied for treating conditions ranging from urinary tract infections in pregnant women to ear infections in children and dental infections. This article explores how potassium clavulanate is being used in clinical research, its effectiveness, and what patients might expect when taking medications containing this compound.

# Potassium Clavulanate: Uses, Effectiveness, and Applications Table of Contents – [What is Potassium Clavulanate?](#what-is-potassium-clavulanate) – [How Potassium Clavulanate Works](#how-potassium-clavulanate-works) – [Medical Conditions Treated](#medical-conditions-treated) – [Formulations and Dosing](#formulations-and-dosing) – [Clinical Studies and Evidence](#clinical-studies-and-evidence) – [Side Effects and Safety Concerns](#side-effects-and-safety-concerns) – [Special Populations](#special-populations) – [Preventive Uses](#preventive-uses) What is Potassium Clavulanate? Potassium clavulanate is not typically used as a standalone medication but is instead combined with antibiotics, most commonly amoxicillin. This combination is known by various brand names including Augmentin[1]. Potassium clavulanate itself is not an antibiotic but works as a beta-lactamase inhibitor that helps other antibiotics work more effectively. When bacteria develop resistance to antibiotics like amoxicillin, they often produce enzymes called beta-lactamases that can break down the antibiotic before it kills the bacteria. Potassium clavulanate blocks these enzymes, allowing the antibiotic to work effectively against bacteria that would otherwise be resistant[2]. How Potassium Clavulanate Works Potassium clavulanate functions by inhibiting beta-lactamase enzymes produced by bacteria. These enzymes typically destroy beta-lactam antibiotics (like amoxicillin) by breaking open their chemical structure. When clavulanate is present, it: 1. Binds to the beta-lactamase enzymes 2. Prevents them from breaking down the antibiotic 3. Allows the antibiotic to reach its target and kill the bacteria This mechanism makes the combination of amoxicillin and clavulanate potassium effective against many resistant strains of bacteria that would not respond to amoxicillin alone[3]. Medical Conditions Treated The combination of amoxicillin and potassium clavulanate is used to treat a variety of bacterial infections, including: # Respiratory Tract Infections – Acute bacterial sinusitis – Respiratory tract infections, including those in HIV patients[4] – Acute otitis media (middle ear infection) in children[2] # Skin and Soft Tissue Infections – Uncomplicated skin and soft tissue infections[5] – Infected wounds # Urinary Tract Infections – Recurrent urinary tract infections, particularly in pregnant women[1] – Asymptomatic bacteriuria during pregnancy # Other Conditions – Acute appendicitis (as an alternative to surgery in some cases)[6] – Dental infections, including symptomatic periapical periodontitis[7] Formulations and Dosing Amoxicillin-clavulanate potassium is available in multiple formulations with varying ratios of the two components. Some common formulations include: # Standard Formulations – 875 mg amoxicillin/125 mg clavulanate (7:1 ratio)[5] – 600 mg amoxicillin/42.9 mg clavulanate (14:1 ratio) # Reduced Clavulanate Formulations Recent studies have investigated formulations with lower amounts of clavulanate to reduce side effects: – 600 mg amoxicillin/21.5 mg clavulanate (28:1 ratio)[2] # Extended Release Formulations – Augmentin XR (extended-release) for adolescents and adults[3] Dosing varies based on: – The patient’s age and weight – The type and severity of infection – The specific formulation being used For example, a typical adult dose might be 875 mg amoxicillin/125 mg clavulanate twice daily, while children might receive weight-based dosing calculated as mg per kg of body weight[2]. Clinical Studies and Evidence Several clinical trials have evaluated the effectiveness of potassium clavulanate combined with amoxicillin: # Acute Otitis Media Studies A study investigated reduced clavulanate formulations in children aged 6-23 months with acute otitis media. The research found that formulations with a 28:1 ratio of amoxicillin to clavulanate administered at either 90/3.2 mg/kg/day or 80/2.85 mg/kg/day were effective while potentially reducing gastrointestinal side effects compared to standard formulations[2]. # Appendicitis Treatment A randomized multicenter trial compared antibiotic therapy using amoxicillin/clavulanate potassium versus appendectomy for treating acute non-complicated appendicitis. The study measured outcomes including: – Rate of intra-abdominal infections – Duration of hospitalization – Time away from work – Recurrence rates (for the antibiotic group)[6] # Dental Applications Two separate studies examined the effects of amoxicillin/clavulanic acid on postoperative pain following endodontic treatment for symptomatic periapical periodontitis. One study evaluated a preoperative single dose, while another assessed a 5-day postoperative regimen[7][8]. # Pharmacokinetic Studies Research has been conducted to understand how amoxicillin and clavulanate are absorbed, distributed, and eliminated in different populations, including adolescents. These studies help determine appropriate dosing regimens for different age groups[3]. Side Effects and Safety Concerns While generally safe and effective, amoxicillin/clavulanate potassium can cause several side effects: # Gastrointestinal Effects – Diarrhea (most common side effect, related specifically to the clavulanate component)[2] – Nausea and vomiting – Abdominal discomfort In clinical studies, protocol-defined diarrhea (three or more watery stools in one day or two watery stools daily for two consecutive days) has been reported in approximately 25% of patients receiving standard formulations[2]. # Skin Reactions – Diaper dermatitis in infants and young children – Rash – Allergic reactions # Other Concerns – Antibiotic resistance with improper use – Potential for secondary infections (like yeast infections) – Rarely, more serious allergic reactions or liver effects Research into reduced clavulanate formulations has been driven by the desire to maintain efficacy while reducing these side effects, particularly diarrhea[2]. Special Populations # Pregnant Women Amoxicillin/clavulanate has been studied and used in pregnant women, particularly for treating and preventing urinary tract infections. Research has shown that recurrent bacteriuria during pregnancy can be reduced from 38% to 8% with preventive antibiotic treatment[1]. # Children and Adolescents Special formulations and dosing schedules have been developed for pediatric populations: – For children with acute otitis media, reduced clavulanate formulations have shown promising results with potentially fewer side effects[2] – Pharmacokinetic studies in adolescents have helped establish appropriate dosing for this age group[3] # Breastfeeding Women In studies involving postpartum women, medications were adjusted for breastfeeding mothers to ensure safety for both mother and infant[1]. Preventive Uses Beyond treating active infections, amoxicillin/clavulanate has been studied for preventive (prophylactic) uses: # Postpartum Infection Prevention Research has examined the efficacy of preventive antibiotic treatment during the puerperium (the period immediately after childbirth) in women who had recurrent urinary tract infections or pyelonephritis during pregnancy[1]. # Dental Procedures Single preoperative doses have been studied for preventing post-procedural infections and reducing pain following dental procedures[7]. ### Long-term Prevention In some cases, long-term preventive therapy may be considered for patients with highly recurrent infections, though this must be balanced against the risk of developing antibiotic resistance.
Medical Condition Formulation Used Key Findings/Purpose Patient Population
Urinary Tract Infections Preventive antibiotic treatment including amoxicillin/clavulanate potassium Examining efficacy of preventive treatment during puerperium (post-delivery period) in women with recurrent UTIs during pregnancy Pregnant women with two or more episodes of bacteriuria or one episode of pyelonephritis
Acute Otitis Media Reduced clavulanate formulation (28:1 ratio vs standard 14:1) Testing whether reduced clavulanate content decreases diarrhea and diaper dermatitis while maintaining effectiveness Children 6-23 months with acute ear infections
Respiratory Tract Infections Amoxicillin/clavulanate potassium extended release Determining pharmacokinetic profiles in adolescent patients Adolescents weighing at least 40kg with acute bacterial sinusitis
Acute Appendicitis Amoxicillin/clavulanate potassium Comparing antibiotic therapy versus surgical appendectomy for acute non-complicated appendicitis Adult patients with confirmed non-complicated appendicitis
Skin and Soft Tissue Infections Augmentin 1gm (875mg amoxicillin/125mg clavulanic acid) Evaluating efficacy and safety in uncomplicated skin and soft tissue infections Patients with skin and soft tissue infections in Pakistan
HIV-related Sinusitis Amoxicillin/clavulanate potassium with pseudoephedrine Comparing Traditional Chinese Medicine versus standard antibiotic therapy HIV-infected individuals with chronic sinusitis
Symptomatic Periapical Periodontitis Amoxicillin/clavulanate potassium 875mg-125mg Evaluating effects on post-operative endodontic pain and swelling Adult patients undergoing root canal treatment

FAQ

  • What is potassium clavulanate and how does it work? Potassium clavulanate is not an antibiotic itself, but a beta-lactamase inhibitor that is combined with antibiotics like amoxicillin. Many bacteria have developed resistance to certain antibiotics by producing enzymes called beta-lactamases that break down the antibiotics. Potassium clavulanate blocks these enzymes, allowing the antibiotic to work effectively against bacteria that would otherwise be resistant.
  • What conditions are being treated with potassium clavulanate in clinical trials? According to the clinical trials data, potassium clavulanate (usually combined with amoxicillin) is being studied for treating various conditions including urinary tract infections in pregnant women, acute otitis media (ear infections) in children, skin and soft tissue infections, respiratory tract infections, sinusitis in HIV patients, acute appendicitis, and symptomatic periapical periodontitis (dental infections).
  • What are the common side effects of medications containing potassium clavulanate? From the clinical trials data, common side effects include diarrhea (which is directly related to the clavulanate component), diaper dermatitis in infants and young children, and gastrointestinal discomfort. One study specifically focused on developing a reduced clavulanate formulation to decrease the incidence of diarrhea in children taking amoxicillin-clavulanate for ear infections.
  • How is potassium clavulanate administered to patients? Potassium clavulanate is administered in various forms depending on the condition and patient. In the clinical trials, it was given as oral tablets, oral liquid suspensions for children, and intravenous formulations. Dosing schedules varied from single preoperative doses for dental procedures to twice daily for 10 days for ear infections, or three times daily for certain infections.
  • Is potassium clavulanate being used as an alternative to surgery in any conditions? Yes, one interesting clinical trial is comparing antibiotic therapy (including amoxicillin/clavulanate potassium) versus appendectomy for acute, uncomplicated appendicitis. This trial aims to determine if antibiotic treatment could be as safe and effective as surgery for certain appendicitis cases, potentially offering patients a non-surgical treatment option with fewer risks and shorter recovery time.

Ongoing Clinical Trials on POTASSIUM CLAVULANATE

  • Comparing local gentamicin or vancomycin hydrochloride to a drug combination for patients with diabetic foot osteomyelitis

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

  • Study on Amoxicillin and Potassium Clavulanate for Preventing Anal Fistula in Patients After First Perianal Abscess Surgery

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

References

  1. https://clinicaltrials.gov/study/NCT01507974
  2. https://clinicaltrials.gov/study/NCT02630992
  3. https://clinicaltrials.gov/study/NCT00354965
  4. https://clinicaltrials.gov/study/NCT00002149
  5. https://clinicaltrials.gov/study/NCT00343135
  6. https://clinicaltrials.gov/study/NCT00135603
  7. https://clinicaltrials.gov/study/NCT03033147
  8. https://clinicaltrials.gov/study/NCT03007342