In short
Cefditoren pivoxil is a third-generation cephalosporin antibiotic taken by mouth. It is already authorised as a medicine in Spain under the trade name Meiact, and the EU Clinical Trials Information System (CTIS) lists it as the test substance in one Phase 3 trial. That trial is comparing outpatient treatment with antibiotics against treatment without antibiotics in 282 patients with acute uncomplicated diverticulitis.
Key points
- Cefditoren pivoxil is a third-generation cephalosporin antibiotic taken by mouth.
- It is already authorised as a medicine in Spain under the trade name Meiact.
- The CTIS registry lists one Phase 3 trial investigating cefditoren pivoxil.
- The trial studies acute uncomplicated diverticulitis in 282 participants.
- The trial compares outpatient treatment with antibiotics against treatment without antibiotics.
- The main measure is therapeutic failure rate within 48 hours and at one month.
What is cefditoren pivoxil?
Cefditoren pivoxil is a semi-synthetic cephalosporin antibiotic for oral administration. It belongs to the class of third-generation cephalosporins, a group of beta-lactam antibiotics that act mainly on both gram-positive and gram-negative bacteria. The substance is a prodrug: after being taken by mouth, it is converted by enzymes called esterases during absorption, and the active form, cefditoren, is distributed in the bloodstream. In the CTIS registry, cefditoren pivoxil is recorded as a chemically synthesised substance and is authorised as a medicine in Spain, where it is sold under the trade name Meiact 200 mg film-coated tablets. Other trade names include Spectracef.
How does cefditoren pivoxil work?
Cefditoren pivoxil works by interfering with the building of the bacterial cell wall. Its target is a group of proteins called penicillin-binding proteins, which bacteria need to construct the peptidoglycan layer that gives the cell wall its strength. By inhibiting cell wall biosynthesis, the antibiotic causes the bacterial cell to become unstable and die. Cefditoren pivoxil is therefore described as a cell wall biosynthesis inhibitor. The US Food and Drug Administration (FDA) has published interpretive criteria for how well the drug works against specific pathogens, including Streptococcus pneumoniae and Haemophilus influenzae.
Which conditions is it used or studied for?
- Acute uncomplicated diverticulitis — the condition being studied in the CTIS trial, which tests whether outpatient treatment without antibiotics is as effective and safe as treatment with antibiotics.
- Pharyngitis and tonsillitis — listed among the diseases for which cefditoren pivoxil has efficacy, according to the KEGG drug database.
- Bacterial infections caused by susceptible organisms — the FDA notes that the drug should be used only to treat infections proven or strongly suspected to be caused by bacteria.
How is cefditoren pivoxil given?
Cefditoren pivoxil is given by mouth as a film-coated tablet. Tablets are available in strengths of 200 mg and 400 mg of cefditoren as cefditoren pivoxil. In the CTIS trial, the product used is Meiact 200 mg film-coated tablets, given orally at a total daily dose of 400 mg. The tablets contain inactive ingredients including croscarmellose sodium, mannitol, magnesium stearate, sodium caseinate, and sodium tripolyphosphate.
What do the clinical trials show?
The CTIS registry lists one Phase 3 trial for cefditoren pivoxil, the ADIANA Trial. It is an interventional, multicentre study in 282 participants with acute uncomplicated diverticulitis. The trial compares two outpatient strategies: treatment with antibiotics versus treatment without antibiotics. The antibiotic arm includes cefditoren pivoxil as one of several possible oral antibiotics, alongside cefuroxime, metronidazole, ciprofloxacin, and amoxicillin/clavulanic acid. The main outcome is the therapeutic failure rate, measured early (within 48 hours or less) and at one month, for both treatment approaches. The trial is currently authorised, meaning it has received approval to proceed.
What side effects are known?
The sources provided for this page do not include a detailed side-effect profile for cefditoren pivoxil. The DailyMed label mentions that the tablets contain sodium caseinate, a milk protein, which is relevant for people with milk protein allergy, but does not list common or serious adverse reactions in the excerpt provided.