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Azithromycin or placebo tablets
Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit.
Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. Used for Bacterial infections (approved indication), Chronic airway inflammation and bronchiectasis (investigational use at Rigshospitalet).
At a glance
| Generic name | Azithromycin or placebo tablets |
|---|---|
| Also known as | Project number HSA06-20/1 |
| Sponsor | Rigshospitalet, Denmark |
| Drug class | Macrolide antibiotic |
| Target | Bacterial 50S ribosomal subunit |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease; Respiratory/Immunology (in investigational use) |
| Phase | FDA-approved |
Mechanism of action
Azithromycin binds to the bacterial 50S ribosomal subunit and inhibits peptide translocation, preventing protein synthesis and leading to bacteriostatic effects. Beyond its antimicrobial properties, azithromycin has immunomodulatory effects including reduction of inflammatory cytokines and mucus hypersecretion, which may be therapeutically relevant in chronic inflammatory airway diseases.
Approved indications
- Bacterial infections (approved indication)
- Chronic airway inflammation and bronchiectasis (investigational use at Rigshospitalet)
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea, abdominal pain)
- Headache
- QT prolongation
- Vaginitis
Key clinical trials
- Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults (PHASE3)
- Non-Surgical Treatment of Peri-implantitis with Systemic Azithromycin or Placebo (PHASE4)
- Azithromycin-Prevention in Labor Use Study (A-PLUS) (PHASE3)
- Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections (NA)
- Placebo-Controlled Trial of Antibiotic Therapy in Adults With Suspect Lower Respiratory Tract Infection (LRTI) and a Procalcitonin Level (NA)
- Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries (PHASE4)
- Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death (PHASE3)
- Anti-chlamydophila Antibiotic Combination Therapy in the Treatment of Patients With Coronary Heart Disease (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Azithromycin or placebo tablets CI brief — competitive landscape report
- Azithromycin or placebo tablets updates RSS · CI watch RSS
- Rigshospitalet, Denmark portfolio CI