Azithromycin: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Azithromycin appears in the FDA drug-label database. Marketed as Azithromycin.
FDA-approved use
Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2) ] Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: • Acute bacterial exacerbations of chronic bronchitis in adults () • Acute bacterial sinusitis in adults () • Uncomplicated skin and skin structure infections in adults () • Urethritis and cervicitis in adults () • Genital ulcer disease in men () • Acute otitis media in pediatric patients (6 months of age and older) ( 1.2 ) • Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (, 1.2 ) • Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (, 1.2 ) Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness o…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| cGMP deviations: Temperature abuse — Mckesson Medical-Surgical Inc. Corporate Office | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-04-13 |
| Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant. — Pfizer Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2014-01-02 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Asthma | 2 |
| Asthma Attack | 1 |
| Asthma Exacerbations | 1 |
| Critical Illness | 1 |
| Labor Complication | 1 |
| Obesity | 1 |
| Obesity in Pregnancy | 1 |
| Pediatric Asthma | 1 |
Recruiting trials involving Azithromycin
- Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0
- Azithromycin for Critical Asthma - Pediatrics
- Individualizing Treatment for Asthma in Primary Care (Full Study)
Common questions
Is Azithromycin FDA-approved?
Yes, marketed as Azithromycin.
How many recruiting trials involve Azithromycin?
3 recruiting trials across 8 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.