Drugs / Azithromycin
Azithromycin
DrugAzithromycin is a macrolide-class antibiotic used to treat bacterial infections, including respiratory, ENT, skin, and sexually transmitted infections. It is available in oral, intravenous, and ophthalmic forms and marketed under brands such as Zithromax. It is a widely prescribed generic medicine.
- Trials
- 524
- Recruiting
- 31
- Completed
- 307
- With results
- 120
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | 3 | 1 | — | 2 | 1 | 7 |
| Phase 1 | 1 | 1 | — | 36 | — | 2 | — | 4 | 44 |
| Phase 1/2 | — | — | 1 | 1 | 2 | 3 | — | 4 | 11 |
| Phase 2 | 4 | 1 | 1 | 40 | 18 | 6 | — | 13 | 83 |
| Phase 2/3 | 3 | — | — | 10 | 5 | 1 | 1 | 2 | 22 |
| Phase 3 | 6 | 2 | 2 | 77 | 13 | 10 | 2 | 11 | 123 |
| Phase 4 | 12 | 6 | 4 | 75 | 9 | 9 | — | 16 | 131 |
| Not applicable | 3 | 4 | 1 | 52 | 6 | 1 | 1 | 13 | 81 |
| Unknown | 2 | — | 1 | 13 | — | — | — | 6 | 22 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| COVID-19 | 2 | 1 | 1 | 15 | 5 | 23 | 3 | 5 | 3 | 58 |
| HIV Infections | — | 3 | — | 3 | — | 3 | — | 11 | 1 | 21 |
| Pulmonary Disease, Chronic Obstructive | 1 | — | — | 4 | — | 6 | 6 | 3 | 1 | 21 |
| Asthma | — | — | — | 3 | — | 5 | 10 | 2 | — | 20 |
| Acquired Immunodeficiency Syndrome | — | 2 | — | 2 | — | 4 | — | 10 | — | 18 |
| Infections | — | 4 | — | 2 | — | 2 | 6 | 2 | 1 | 17 |
| Mycobacterium avium-intracellulare Infection | — | — | — | 3 | 1 | 4 | 1 | 8 | — | 17 |
| Pneumonia | — | — | — | 1 | 2 | 4 | 7 | 1 | 2 | 17 |
| Trachoma | — | — | — | — | 1 | 3 | 12 | 1 | — | 17 |
| Malaria | — | 2 | 1 | 2 | 1 | 5 | 4 | 1 | — | 16 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Pfizer | 41 | 18 |
| 2 | University of California, San Francisco | 26 | 4 |
| 3 | National Institute of Allergy and Infectious Diseases (NIAID) | 21 | 4 |
| 4 | Merck Sharp & Dohme LLC | 9 | 2 |
| 5 | Laboratoires Thea | 8 | 2 |
| 6 | London School of Hygiene and Tropical Medicine | 8 | 6 |
| 7 | Assistance Publique - Hôpitaux de Paris | 6 | 4 |
| 8 | University of Alabama at Birmingham | 6 | 0 |
| 9 | Washington University School of Medicine | 6 | 2 |
| 10 | Assiut University | 5 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Azithromycin | 524 |
| 2 | Hydroxychloroquine | 61 |
| 3 | Doxycycline | 36 |
| 4 | Amoxicillin | 28 |
| 5 | Ceftriaxone | 18 |
| 6 | Erythromycin | 18 |
| 7 | Chloroquine | 16 |
| 8 | Ethambutol | 16 |
| 9 | Clarithromycin | 15 |
| 10 | Levofloxacin | 15 |
Evidence
- Results reported
- 39.1%120 of 307 completed
- Published
- 11.7%36 of 307 completed
- Primary endpoint met
- 26%19 of 73 analyses
- Median months to report
- 14
Documents disclosed
Trial profile
- Median enrollment
- 112
- Median duration
- 22months
- Countries
- 97
- Study sites
- 2443
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 35
- Phase 1
- 40
- Phase 1/2
- 30
- Phase 2
- 63
- Phase 2/3
- 200
- Phase 3
- 264
- Phase 4
- 147
- Not applicable
- 106
- Unknown
- 438
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Birmingham | United States | 29 |
| 2 | San Francisco | United States | 26 |
| 3 | New York | United States | 23 |
| 4 | Baltimore | United States | 22 |
| 5 | New Orleans | United States | 21 |
| 6 | Philadelphia | United States | 21 |
| 7 | Chicago | United States | 20 |
| 8 | Houston | United States | 19 |
| 9 | St Louis | United States | 19 |
| 10 | Cleveland | United States | 18 |
Terminations
- Terminated
- 54
- Withdrawn
- 32
- Suspended
- 6
- Stopped for recruitment
- 3.8%20 of 524 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT06207786 Withdrawn | Withdrawn | Lack of resources to support the trial | 2030-05-31 |
| NCT06289647 Withdrawn | Withdrawn | Study withdrawn (no participants enrolled) due to resources. | 2029-08-31 |
| NCT03523156 Withdrawn | Withdrawn | The Trachoma Elimination Study by Focused Antibiotic (TESFA): The Impact of an Enhanced Antibiotic Treatment Regimen on Trachoma in Amhara, Ethiopia is withdrawn due to severe delays and continued insecurity in the Amhara region of Ethiopia. | 2027-04-30 |
| NCT04669288 Terminated | Terminated | The AZ-SWED trial was stopped by the National Heart, Lung, and Blood Institute (NHLBI) due to futility | 2025-01-08 |
| NCT05345457 Terminated | Terminated | Low enrollment | 2024-02-26 |
| NCT05288023 Terminated | Terminated | AVENIR I demonstrated efficacy of azithromycin MDA targeted to children 1-59 over 1-11 months in July 2023, thus this trial was stopped before outcomes were collected so Niger could expand the program nationally to include children 1-59 months. | 2024-01-15 |
| NCT04186247 Terminated | Terminated | The DSMB concluded that feasibility endpoints were reached in time for Week 4 but no participants receiving standard of care dietary treatment could be randomized based on the at-risk of the microbiome signature. | 2023-12-31 |
| NCT03060473 Terminated | Terminated | Patient population that meets study criteria is insufficient to continue project in a reasonable amount of time. To continue is futile in resources, staff time, and effort. | 2023-12-08 |
| NCT05473234 Terminated | Terminated | Study was halted due to low follow-up rates and issues with data collection | 2023-11-29 |
| NCT04348474 Suspended | Suspended | Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study. | 2023-07-31 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: