Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media

2015-12-16 05:08:22 | BioPortfolio


To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days. Investigators will focus on the proportion of subjects who develop protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the prescription of antifungal medication.


Amoxicillin-clavulanate potassium has been shown to be efficacious in eradicating causative pathogens in acute otitis media (AOM) with resulting high clinical cure rates at end-of-treatment (85%). However, relatively high rates (~25%) of clinically significant diarrhea have been reported, the occurrence of which has been directly related to the clavulanate potassium component of the drug combination. A reduced concentration of clavulanate potassium in the drug formulation would be expected to have an improved safety profile regarding the occurrence of diarrhea. This study will examine whether the concentration of the clavulanate potassium component of amoxicillin-clavulanate potassium could be reduced in the treatment of children 6 months through 23 months of age diagnosed with AOM using stringent criteria. A total of 75 participants (n=75) with AOM will receive amoxicillin-clavulanate potassium (600 mg/21.5 mg/5 mL; 28:1) administered at 90/3.2 mg/kg in two divided doses for 10 days.

The primary outcome measure will be rates of clinically significant diarrhea and diaper dermatitis. These rates will be compared with the rate observed in our previous studies of AOM in children who received amoxicillin-clavulanate potassium (600 mg/42.9 mg/5 mL; 14:1) administered at 90/6.4 mg/kg in two divided doses for 10 days.

A subset of this group will have pharmacokinetic studies performed. Each participant that agrees will have a single blood draw (n=50). Investigators will analyze amoxicillin and clavulanate potassium in the blood samples using validated methods.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label


Acute Otitis Media


Amoxicillin-Clavulanate potassium


Children's Hospital of Pittsburgh of UPMC
United States




University of Pittsburgh

Results (where available)

View Results


Published on BioPortfolio: 2015-12-16T05:08:22-0500

Clinical Trials [854 Associated Clinical Trials listed on BioPortfolio]

Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children

This is a randomized, controlled trial studying the effects of various antimicrobial treatments on the intestinal microbiome of small children. The participating children with acute otitis...

Amoxicillin Clavulanate in Treatment of Acute Otitis Media

This is a prospective, randomized, double-blind, placebo controlled one-center study carried out in primary care setting of the health center of City of Turku, Finland. The study patients ...

Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media

The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who...

A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on am...

A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months

The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment o...

PubMed Articles [8482 Associated PubMed Articles listed on BioPortfolio]

Acute Otitis Media and Group A Streptococcal Pharyngitis: A Review for the General Pediatric Practitioner.

For pediatric practitioners, acute otitis media (AOM) and group A streptococcal pharyngitis are two of the most common infections seen in ambulatory practices. The purpose of this article is to review...

Oral amoxicillin and amoxicillin-clavulanate: properties, indications, and usage.

Amoxicillin has been in use since the 1970s; it is the most widely used penicillin both alone and in combination with the beta-lactamase clavulanic acid.

Correlation between Type of Clefting and the Incidence of Otitis Media among Children with Lip and/or Palate Clefts.

Otitis media is a frequent condition among children with high morbidity. Orofacial clefts are undoubtedly one of the most well-established risk factors for otitis media during childhood. The clinical ...

Trend and patterns in the antibiotics prescription for the acute otitis media in Korean children.

The Korean Otologic Society developed guidelines for treatment of acute otitis media (AOM) in 2010, which advocated limiting the prescription of antibiotics. However, it is not known whether this has ...

Can Reflux Symptom Index and Reflux Finding Score Be Used to Guide the Treatment of Secretory Otitis Media in Adults?

At present more attention is paid to the treatment of secretory otitis media in children, but there is also a high incidence of adult patients. The etiology of secretory otitis media in adults is comp...

Medical and Biotech [MESH] Definitions

A fixed-ratio combination of amoxicillin trihydrate (see AMOXICILLIN), an aminopenicillin, and potassium clavulanate (see CLAVULANIC ACID), a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.

Inflammation of the ear, which may be marked by pain (EARACHE), fever, HEARING DISORDERS, and VERTIGO. Inflammation of the external ear is OTITIS EXTERNA; of the middle ear, OTITIS MEDIA; of the inner ear, LABYRINTHITIS.

Inflammation of the middle ear with purulent discharge.

Inflammation of the MIDDLE EAR including the AUDITORY OSSICLES and the EUSTACHIAN TUBE.

Inflammation of the honeycomb-like MASTOID BONE in the skull just behind the ear. It is usually a complication of OTITIS MEDIA.

More From BioPortfolio on "Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media"

Quick Search

Relevant Topics

Dermatitis means an inflammation of the skin. Contact dermatitis is a term used when this inflammation is caused by contact with something in the environment. The changes of dermatitis seen in the skin take the form of eczema; hence it may sometimes be r...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Searches Linking to this Trial